BioCentury This Week

AbbVie's $10.9 billion deal to acquire Apogee will expand its immunology pipeline by delivering assets for atopic dermatitis and asthma. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the takeout and the assets AbbVie gains. The analysts then discuss moves by FDA to reverse controversial setbacks that occurred under the agency’s former leadership and assess Acting CDER Director Michael Davis’ memo outlining how his predecessor repeatedly overruled career staff to quash a drug approval. The analysts also discuss continuing signs of political involvement at FDA. Finally, they discuss China NMPA’s first-ever approval of a CAR T for solid tumors, satricabtagene autoleucel (satri-cel) from Carsgen. View full story: https://www.biocentury.com/article/659864 #BiotechMA #Immunology #FDA #CART #ChinaBiotech 00:59 - AbbVie Buys Apogee 05:20 - uniQure U-turn 09:02 - FDA Reversals 12:32 - Tzield Memo 20:53 - Solid Tumor CAR T Approval To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Biotech IPOs that are getting out remain hot — but will that continue into the fall? On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for fresh biotech paper on NASDAQ, including the $770 million debut by  Parabilis, the largest IPO in the sector’s history. The analysts also discuss the Biosecure Act and U.S. policy toward China; the cachexia pipeline; and BioCentury’s updated Innovation Distillery. View full story: https://www.biocentury.com/article/659773 #BiotechIPO #NASDAQ #BiosecureAct #Cachexia #ChinaBiotech  00:36 - Innovation Distillery 03:56 - Biotech IPOs 10:13 - Biosecure Act, WuXi AppTec 16:03 - Cachexia Pipeline 22:03 - Ouster for RFK Jr.? To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Getting into the clinic fast to de-risk assets has become the name of the game in biotech, and at the academia-industry interface, too. From AI to NAMs to starting a Phase I trial in the U.S., BioCentury’s 3rd Grand Rounds-U.S. conference brought together academic innovators, biopharma leaders and early-stage investors to debate key bottlenecks in translation and how to make early-stage R&D investible. Sam Blackman, entrepreneur in residence at GV and co-founder of Day One Biopharmaceuticals, and Aaron Coe, managing director of innovation for the Allen Institute, joined BioCentury’s analysts on stage last week in Seattle for a podcast recording to wrap up Grand Rounds and discuss key takeaways from the event. Editor’s note: We invite you to join BioCentury and Regional Host Chairs Forbion and BGV at our next edition of BioCentury Grand Rounds, scheduled for Sept. 23-25 in Amsterdam. View full story: https://www.biocentury.com/article/659729 #TranslationalScience #DrugDevelopment #BiopharmaInnovation #AcademicInnovation #GrandRoundsUS 00:53 - World-Class Regional Hosts 02:56 - Building Grand Rounds Community 05:21 - Two Nobels, One City 07:43 - AI Goes End-to-End 09:47 - The Data Problem 14:12 - AI, Animals, Australia 19:53 - Study Startup Bottlenecks 26:11 - Early Science Investability To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

FDA’s new leadership is sailing the agency into calmer waters amid a search for a permanent commissioner and permanent center directors. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses how FDA’s new, interim leaders have changed the tone at the agency and why they are putting medicines derailed under former FDA Commissioner Marty Makary back on track. Usdin also highlights FDA’s new real-time clinical trials initiative. BioCentury’s analysts then turn to deals, including an analysis of the 20 deals Eli Lilly has done this year; Servier’s move to expand in neurology via BD; and Monday’s billion-dollar deals by Incyte, which will acquire Vega Therapeutics, and Johnson & Johnson, which is buying Firefly Bio. The team also discusses Grand Rounds U.S., held last week in Seattle, including the conference’s Rising Star prize winner Sylvain Simon of Fred Hutchinson Cancer Center. View full story: https://www.biocentury.com/article/659699 #FDA #BiopharmaDeals #ClinicalTrials #BiotechMA #GrandRoundsUS 01:23 - Grand Rounds Seattle Takeaways 04:43 - FDA's New Leaders 11:48 - FDA's Real Time Trials Pilot 20:40 - Servier Bets on Neuro 25:33 - Lilly's Deal Spree 30:21 - Dealmaking Roundup To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Revolution Medicines continues to impress with more pancreatic cancer data, earning a standing ovation at ASCO over the weekend. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the detailed data for the company’s daraxonrasib, Akeso’s Harmoni-6 readout, as well as other results from the meeting. BioCentury’s analysts then argue that U.S. biotech executives and policymakers should embrace the challenges and opportunities that come with the rise of innovation in China — rather than sticking their heads in the sand. They also discuss why leaders of the U.S.’s biggest drug companies should use their influence to stop an OMB proposal that threatens the foundations of U.S. science. Plus: takeaways from BioCentury's conversation with Alkermes CEO Richard Pops on The BioCentury Show. View full story: https://www.biocentury.com/article/659629 #ASCO #PancreaticCancer #BiotechInnovation #ChinaBiotech #DrugDevelopment 00:00 - Introduction 01:49 - ASCO: RevMed 06:50 - ASCO: Akeso 16:33 - China U.S. Biotech Rivalry 24:15 - Science Under Threat 36:29 - Richard Pops Takeaways To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

At ASCO among presentations focused on pancreatic cancer innovation beyond KRAS; however, abstracts for the cancer conference also highlight ADCs, bispecifics and diagnostics that are broadening the field’s approach to the cancer. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Revolution’s daraxonrasib, other readouts to watch for in pancreatic cancer and what else is on BioCentury’s radar at this year’s American Society of Clinical Oncology meeting. BioCentury’s analysts also discuss a push by China hawks in Congress to get the Trump administration to invoke national security powers to narrow Chinese life sciences companies’ access to U.S. markets, technology and capital; an initiative by Rep. Jake Auchincloss (D-Mass.) that seeks to modernize how clinical trials are conducted in the U.S.; and a BioCentury analysis on new antibody-drug conjugate linker techniques. This episode of the BioCentury podcast is brought to you by Jeito Capital. View full story: https://www.biocentury.com/article/659581  #Biopharma #ASCO2026 #PancreaticCancer #ClinicalTrials #ADCInnovation 00:01 - Sponsor Message: Jeito Capital 02:26 - ASCO Preview 14:24 - U.S. China Policy 22:48 - Modernizing U.S. trials 27:17 - Optimizing ADC Linkers To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Marty Makary wasn’t the only official on the outs at FDA last week in another tumultuous turn of events for the regulatory agency. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses who’s in, who’s out and what’s next at FDA — and why the changes may mean more conservative decision-making at the agency in the near term. BioCentury’s analysts also discuss the new obesity targets that came to light at last week’s annual meeting of the European Congress on Obesity, the market for biotech IPOs, and the emergence of degrader-antibody conjugates. DACs pair the tissue-targeting logic of antibody-drug conjugates (ADCs) with the catalytic activity of protein degraders. 3C Therapeutics is the latest entrant to the field, pitching its TriCore platform as a modular backbone for DAC generation. This episode of the BioCentury podcast is brought to you by Jeito Capital. View full story: https://www.biocentury.com/article/659510 #FDA #ObesityDrugDevelopment #BiotechIPO #DACs #Biopharma 00:01 - Sponsor Message: Jeito Capital  02:53 - FDA Leadership Shakeup 10:35 - Obesity Target Hunt 16:07 - Biotech IPOs 20:02 - Degrader-antibody Conjugates 28:42 - Serif: Non-viral DNA To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

China’s speed in generating first-in-human data has catalyzed a race across the globe to reshape regulatory requirements to compete. BioCentury’s analysts, along with special guests Detlev Mennerich, head of Boehringer Ingelheim Venture Fund, and Mehdi Ainouche, partner at Jeito Capital, discussed where Europe fits in that landscape and other takeaways from the 26th annual Bio€quity Europe conference in Prague. This special episode of BioCentury This Week has been brought to you by Jeito Capital. View full story: https://www.biocentury.com/article/659450 #EuropeanBiotech #ClinicalDevelopment #BiopharmaInnovation #DrugDevelopment #LifeSciencesStrategy 00:01 - Sponsor Message: Jeito Capital  03:14 - China’s Speed Challenge 04:08 - Europe’s Clinical Trial Opportunity 11:48 - Speed vs. Capital Efficiency 15:52 - Takeaways from Richard Pazdur 19:58 - FDA Uncertainty and Global Alternatives 26:50 - Biopharma M&A Outlook 33:34 - The Next Wave of Science To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Marty Makary’s hold on the top job at FDA is slipping, with White House leaks about President Donald Trump’s displeasure with the FDA commissioner shifting the question from whether he will be fired to when. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin discusses the pressures on Makary, how long he will hold onto his post, and the leading candidates to succeed him. BioCentury’s analysts then discuss solutions to AAV’s redosing problem, which could reignite industry interest in a modality that has fallen out of favor, and other topics in the spotlight at this week’s American Society of Gene and Cell Therapy annual meeting. The analysts also discuss opportunities to attend and present academic posters at the third BioCentury Grand Rounds U.S. conference June 3-5 in Seattle. This episode of the BioCentury This Week podcast has been brought to you by Jeito Capital. View full story: https://www.biocentury.com/article/659426 #FDA #GeneTherapy #AAV #CellTherapy #Biopharma 00:01 - Sponsor Message: Jeito Capital 01:43 - Bio€quity Europe Prague Highlights 04:54 - Makary on Thin Ice 14:37 - Grand Rounds Poster Pitch 16:40 - AAVs at ASGCT To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

UCB is the latest biopharma player to consummate a multibillion-dollar deal amid a surge in biotech M&A activity, acquiring Ken Song’s Candid Therapeutics, one of the leading T cell engager companies. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the $2 billion takeout and the opportunity in the TCE space. They also assess the drug development landscape for leukodystrophies and the market for biotech IPOs on NASDAQ, where a trio of biotechs exceeded expectations last week, lifting hopes that the window for new listings is broadening. Looking ahead to June, the analysts also preview the third BioCentury Grand Rounds U.S. conference. This episode of the BioCentury This Week podcast was brought to you by Jeito Capital. View full story: https://www.biocentury.com/article/659365 #BiotechMA #TCellEngagers #Leukodystrophy #BiotechIPO #TranslationalScience 00:01 - Sponsor Message: Jeito Capital 02:19 - Grand Rounds Seattle 12:47 - UCB’s Candid Buy 20:27 - Leukodystrophies Pipeline 27:22 - Biotech IPOs To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

More than 175 new oncology targets surfaced at this year’s American Association for Cancer Research annual meeting in San Diego, with the focus on new ways to enhance the immune response against solid tumors and to make existing immunotherapies more effective. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the new targets identified among the thousands of abstracts at AACR, as well as emerging pan-RAS inhibiting antibody-drug conjugates. The analysts also discuss Eli Lilly's latest deal — for a JAK-2 inhibitor from Ajax — and what the current pace of M&A and partnerships says about the state of biopharma dealmaking. This episode also features Kurma Partners’ new venture fund and the latest in BioCentury’s Emerging Company Profile series, spotlighting U.K.-based rheumatoid arthritis company Elevara Medicines. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech. View full story: https://www.biocentury.com/article/659298 #AACR #OncologyTargets #Immunotherapy #BiotechMA #ADC 00:01 - Sponsor Message: IQVIA Biotech 02:50 - AACR: New Targets 11:08 - AACR: Pan-RAS Inhibitor ADCs 15:35 - Biopharma Deals 23:53 - Kurma's New Venture Fund 27:28 - Emerging Company Profile: Elevara To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Bispecific antibodies and dual-payload antibody-drug conjugates were in the spotlight at this year’s American Association for Cancer Research meeting in San Diego as biotechs unveiled their latest preclinical and first-in-human oncology data. On a special edition of the BioCentury This Week podcast, IQVIA Biotech CMO James Kyle Bryan joins BioCentury’s analysts to discuss what AACR revealed about modalities gaining traction, plus shares his perspective on de-risking clinical development and eliminating the “white space” that delays biotechs’ timelines in the clinic. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech. View full story: https://www.biocentury.com/article/659235 #AACR #BispecificAntibodies #ADC #OncologyData #ClinicalDevelopment  00:01 - Sponsor Message: IQVIA Biotech 01:43 – AACR Early Signals 05:17 – Antibody Innovation 09:22 – Dual Payload ADCs 13:48 – De-Risking Drug Development 19:16 – Looking Ahead to ASCO To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The past week has delivered the largest M&A deal ever for a private, venture-backed biopharma, the second-largest follow-on ever for a NASDAQ-traded biotech and what could soon become the largest biotech IPO ever on NASDAQ. On the latest BioCentury This Week, BioCentury’s analysts discuss Eli Lilly's $3.25 billion takeout of in vivo CAR T company Kelonia, the market debut by obesity play Kailera and an upsized follow-on by Revolution on the back of its pancreatic cancer data. The analysts also discuss how autoimmune T cell engagers are diverging from their oncology roots and the potential implications of President Donald Trump’s executive order on psychedelic therapies. BioCentury’s analysts also take time to remember Sofinnova Partners’ Denis Lucquin, father of French biotech. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech. View full story: https://www.biocentury.com/article/659183 #BiotechMA #BiotechIPO #CART #TCellEngagers #PsychedelicMedicine 00:01 - Sponsor Message: IQVIA Biotech 04:20 - Lilly's Kelonia Buy 10:31 - T Cell Engagers 23:07 - Psychedelics Executive Order 35:14 - CBER Director Search 37:37 - Public Markets Roundup 42:14 - Remembering Denis Lucquin To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

A pathway proposed by FDA to cut the time it takes biopharma companies to get to first-in-human trials is more ambitious than similar policies in Australia, China and the U.K. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the proposal, as well as a concession for the biopharma industry on first-in-human studies in PDUFA reauthorization negotiations with FDA. The analysts also discuss the latest pair of billion-dollar biotech deals: Gilead's $3.2 billion takeout of antibody-drug conjugate company Tubulis and the acquisition of Soleno by Neurocrine for $2.9 billion for its Prader-Willi asset. Finally, BioCentury’s analysts discuss the new $6.3 billion Blackstone Life Sciences fund and the €1 billion vehicle unveiled last week by European VC Jeito Capital. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech. View full story: https://www.biocentury.com/article/659127 #FDA #FirstInHuman #BiotechMergers #BiotechInvesting #LifeSciencesVC 00:01 - Sponsor Message: IQVIA Biotech 03:24 - FDA First-in-Human 11:44 - America First PDUFA Policy 17:43 - Gilead Buying Tubulis 23:41 - Blackstone's New Fund 28:37 - Jeito Capital 30:44 - Parker Institute To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Biotech has been resilient as the financial markets teeter under global volatility. For now, M&A and financings, if not IPOs, are continuing, but will the Mideast conflict halt biotech’s recovery? On the latest BioCentury This Week podcast, BioCentury’s Stephen Hansen breaks down the near-term and long-term outlook for a biotech industry hoping to continue the growth of 2H25. BioCentury’s analysts also discuss the impact of the Trump administration’s tariffs on the biopharma industry and last week’s biggest deals: the pending $6.3 billion takeout of Centessa  by Eli Lilly and the proposed $5.6 billion acquisition of Apellis by Biogen. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech. Register now as a delegate or apply to join the 2026 Presenting Company Class before the 26th Bio€quity Europe May 4-6 in Prague sells out. View full story: https://www.biocentury.com/article/659040 #BiotechMarkets #BiotechMA #GlobalVolatility #DrugPricingPolicy #BiopharmaStrategy 00:01 - Sponsor Message: IQVIA Biotech 05:09 - 2Q26 Preview 17:09 - Pharma Tariffs 24:04 - C-Path Initiative 26:32 - Lilly Deal 32:19 - Biogen Deal To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Biotech innovators around the world are finding speed to be the driver for investment and partnering — speed to early human data and speed to de-risk assets. The new momentum from Asia, in particular China, has added a fresh challenge for European biotech on top of falling equity and R&D investment in Europe and a complex drug pricing landscape. On a special edition of the BioCentury This Week podcast on the eve of the 26th Bio€quity Europe conference, EQT Life Sciences' Christoph Broja and Prague Bio CEO Petra Kinzlová join BioCentury’s analysts to discuss the challenges faced by European biotech today and what the best strategy is to compete in this new era. Kinzlová also describes a growing biotech ecosystem in the Czech Republic, which will host Bio€quity Europe May 4-6. View full story: https://www.biocentury.com/article/659002 #EuropeanBiotech #ClinicalDevelopmentSpeed #ChinaBiotech #DrugPricing #BiotechInvestment 01:10 - Bio€quity Europe Preview 04:32 - Czech Innovation Hubs 09:52 - Pricing, Trials, Funding 13:07 - Fixing Trial Bottlenecks 17:49 - Pension Capital and Risk To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

A flurry of deals, several with sizable upfront payments, has energized the biotech sector in March. On the latest BioCentury This Week podcast, BioCentury’s Paul Bonanos assesses last week’s deals by Merck, which is laying out $6.7 billion to acquire Terns, and Gilead, which is buying Ouro for about $1.7 billion up front. Gilead’s deal comes as the Foster City, Calif.-based biotech is looking to defend its position in HIV while resetting in inflammation and immunology and growing its oncology footprint through business development. BioCentury’s Lauren Martz analyzes the company’s pipeline following her recent conversation with CMO Dietmar Berger. Turning to the U.K., Editor in Chief Simone Fishburn details her conversation with CEO of MHRA, Lawrence Tallon, regarding what new reforms in the U.K. mean for drug developers and how he views initiatives helping to build the sector and place the U.K. in the race to become a destination for clinical trials. Rates for the 26th Bio€quity Europe May 4-6 in Prague increase after this week. Register now as a delegate or apply to join the 2026 Presenting Company Class before the conference sells out. View full story: https://www.biocentury.com/article/658974 #BiotechMA #BiopharmaStrategy #DrugDevelopment #UKBiotech #ClinicalTrials 00:00 - Introduction 01:09 - Merck Buying Terns 04:31 - Gilead, Galapagos Deal 09:35 - Growing Gilead 19:20 - Tallon's Vision for U.K. Biotech To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

After 20 years of platform building and resets, Arrowhead Pharmaceuticals is making a bid to become a large-cap biotech. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the company has built a pipeline and set of enabling technologies that could enable a steep period of value creation based on RNAi. The team then analyzes the $2 billion deal between Synnovation and Novartis for a pan-mutant-selective PI3Kα inhibitor. The analysts also assess where AI is integrating into the biotech venture funnel and provide insights into ultra-rare disease advocacy, FDA’s search for a successor to CBER Director Vinay Prasad, and the Trump administration’s most-favored nation (MFN) drug pricing policy. View full story: https://www.biocentury.com/article/658892 #RNAiTherapeutics #BiotechMA #PI3KAlpha #AIDrugDiscovery #DrugPricingPolicy 00:00 - Introduction 01:14 - Bio€quity Europe 05:33 - Arrowhead 16:49 - Synnovation Novartis 20:00 - AI in Biotech Venture 27:07 - Rare Disease Advocacy 31:22 - MFN Pricing Policy To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Biotechs have been pricing follow-ons at a steady pace, with some companies parlaying data into upsized deals, and others even beginning to debut on NASDAQ — but will geopolitical tensions and war in the Middle East scuttle the forward momentum? On the latest BioCentury This Week podcast, BioCentury’s analysts take the temperature of the markets for biotech." They also discuss last week’s late-stage epilepsy data from Xenon Pharmaceuticals, which revived the biotech’s stock and the Kv7 target. And, in a Rare Disease Spotlight, BioCentury’s analysts discuss how Friedreich ataxia is moving into a mechanistic second act, with biotechs pivoting from stabilizing the mitochondrial damage caused by frataxin loss to developing therapies designed to fix the gene itself. View full story: https://www.biocentury.com/article/658810 #BiotechMarkets #EpilepsyResearch #Kv7 #RareDisease #GeneTherapy 00:00 - Introduction 03:23 - Market Sentiment 09:58 - Xenon Phase III Win 18:03 - Friedreich Ataxia Pipeline To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Biotechs in South Korea and other regions of Asia outside of China need to lean into innovation to distinguish themselves from their Chinese counterparts. On a special edition of the BioCentury This Week podcast, BioCentury’s analysts are joined by industry guests Ya-Ting Lei and Luther (Ruizhe) Zhao to discuss why the best path for biotechs in Korea and Japan is to lean into target, biology and modality risk, as well as other takeaways from the fifth BioCentury-BayHelix Biopharma Summit, which ran March 9-12 in Seoul and Daejeon, South Korea. Lei is director of BD Asia at Merck KGaA, and Zhao is VP, China clinical analytics at Caidya. View full story: https://www.biocentury.com/article/658776 #AsiaBiotech #SouthKoreaBiotech #BiopharmaSummit #BiotechInnovation #DrugDevelopmentStrategy 00:00 - Introduction 02:32 - Key Takeaways 05:46 - Faster Trials, Better Data 08:19 - Global Diligence, Local Success 15:13 - Cross Border Synergies 17:34 - Korean Biotech To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The second ousting of Vinay Prasad from FDA in the past eight months won’t lead to major changes at the agency, other than selecting a successor tasked with keeping FDA out of the news ahead of the coming midterm elections. On the latest BioCentury This Week podcast, Washington editor Steve Usdin lays out why the former CBER director was pushed out at FDA and what’s next for the agency following his departure. BioCentury’s editors also discuss the next wave of therapies for idiopathic pulmonary fibrosis, including whether new candidates might go beyond slowing disease to halt or even reverse progression, the biological complexity that makes fibrosis so challenging, and what the 20-plus Phase II programs could teach the field about fibrosis biology. Also up for discussion were recent clinical wins — as well as more complicated readouts — from psychedelic therapies; plus the latest data updates from obesity treatments, with a focus on amylin agonists. View full story: https://www.biocentury.com/article/658698 #FDA #IdiopathicPulmonaryFibrosis #PsychedelicTherapies #ObesityDrugs #AmylinAgonists 00:00 - Introduction 01:56 - Prasad's Departure 15:27 - Fibrosis Therapies 23:35 - Psychedelics Clinical Catalysts 28:24 - Obesity Updates To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Can a strong U.S. biopharma industry be reconciled with the successful emergence of China? And can China be a catalyst of positive change across the global industry, even if this implies some level of rebalancing away from the U.S.? On the latest BioCentury This Week podcast, BioCentury’s analysts discuss a Guest Commentary by McKinsey Senior Partner Emeritus Franck Le Deu, who argues that a multipolar biopharma world in which the U.S. continues to thrive even as China becomes meaningfully stronger can emerge. The analysts also discuss BioCentury’s latest Rare Disease Spotlight, which focuses on a wave of therapies aiming to activate retinal function in Stargardt disease patients. Turning to FDA, BioCentury Washington Editor Steve Usdin discusses recent public statements by FDA Commissioner Marty Makary, questions about Vinay Prasad’s future, and the plausible mechanism pathway. View full story: https://www.biocentury.com/article/658606  #GlobalBiopharma #ChinaBiotech #RareDisease #StargardtDisease #FDAPolicy  00:00 - Introduction 02:47 - Multipolar Biopharma World 13:39 - Rare Disease Spotlight 25:15 - Makary Remarks 31:14 - Plausible Mechanism Framework To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Gilead is acquiring Arcellx for $7.8 billion up front three years after forging a partnership with the biotech around a cell therapy for multiple myeloma. On the latest BioCentury This Week podcast, BioCentury’s analysts assess what the deal does for the Foster City, Calif.-based biotech’s pipeline. The analysts also discuss the case for using ctDNA as a surrogate endpoint for early cancer trials. Turning to Washington, Steve Usdin offers his takeaways from last week’s PhRMA Forum, which focused on China and the Trump administration’s most favored nation (MFN) drug pricing policy, and on the lessons that can be drawn from FDA’s about-face on the recent vaccine application from Moderna. View full story: https://www.biocentury.com/article/658516 #BiotechMA #MultipleMyeloma #ctDNA #DrugPricingPolicy #FDA 00:00 - Introduction 02:34 - Gilead's Arcellx Buy 11:14 - ctDNA Surrogate Endpoints 21:59 - PhRMA Forum Takeaways 29:19 - FDA Moderna U-turn To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

As targeted protein degradation gains momentum, oral selective estrogen receptor degraders are emerging as one of its most advanced proving grounds. On the latest BioCentury This Week podcast, BioCentury’s Lauren Martz assesses how the oral SERD landscape is evolving. Washington Editor Steve Usdin then discusses setbacks at FDA for an orphan therapy from Disc Medicine and a vaccine from Moderna, and why he is calling on life sciences industry leaders to publicly demand the dismissal of Vinay Prasad, FDA’s CSO, CMO, and director of CBER. View full story: https://www.biocentury.com/article/658455 #TargetedProteinDegradation #OralSERDs #OncologyDrugDevelopment #FDASetbacks #CBER 00:00 - Introduction 03:12 - Oral SERD Spotlight 11:40 - Setbacks at FDA 15:12 - Disc Medicine CRL To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

2025 marked the end of a four-year slide in series A financings for biotechs, with 144 biotechs raising an aggregate of $8 billion, up $1 billion from the prior two years. On the latest BioCentury This Week podcast, BioCentury’s Danielle Golovin assesses which companies VCs backed last year and what their investments say about where technology is headed. Washington Editor Steve Usdin offers a perspective on why compounded Wegovy is an assault on the biopharma industry and also explains how the spending bill signed into law last week is a rebuke to proposed White House biomedical cuts. And Executive Editor Selina Koch unpacks her interview on The BioCentury Show podcast with neuroscientist and Seaport Chair Steven Paul, noting that while serendipity drives drug discovery in psychiatry, it’s engineering that gets it across the finish line. View full story: https://www.biocentury.com/article/658367 #BiotechFinancing #SeriesAFunding #VentureCapital #DrugDiscovery #BiopharmaPolicy 00:00 - Introduction 02:15 - Start-up Spotlight 11:03 - Compounded Wegovy 18:10 - Congress Rebuffs Trump Cuts 23:50 - Steve Paul on Neuropsychiatry To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

RNAi and exon-skipping therapies headline the list of regulatory and pivotal data catalysts in 2026, while new lipid-lowering mechanisms, modalities, and precision medicines define cardiovascular disease catalysts this year. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the most important milestones of the year in new modalities, CV and renal diseases. The analysts also discuss a new regulation in China introducing orphan drug exclusivity that could incentivize development of rare disease therapies. Dig into the BioCentury’s catalyst picks and the new China policy below • 2026 Catalysts: The rise of RNAi • 2026 Cardiovascular Catalysts: Lp(a) on the Horizon • 2026 Obesity Catalysts: Launches, readouts and challengers • 2026 Catalysts: Breakthrough progress in renal disease • AZ signals all-in on obesity via CSPC deal for $1.2B up front • China’s orphan drug exclusivity could bolster market, incentivize development View full story: https://www.biocentury.com/article/658286 00:00 - Introduction 02:28 - RNAi and Antisense Therapies 06:37 - Neuromuscular and Musculoskeletal 10:33 - Renal Disease Catalysts 22:26 - China's New Orphan Rules To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

New rules in China will accelerate the country’s cell and gene therapy sector by reshaping how investigator-initiated trials are conducted and commercialized. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the new framework and why it will create a powerful incentive for deploying new gene and cell therapies. Executive Editor Selina Koch discusses which milestones she is watching in neurology in the year ahead, from psychedelics to Alzheimer's disease. Finally, Senior Biopharma Analyst Danielle Golovin discusses a pair of stories from BioCentury’s Emerging Company Profile series: one focused on Yale spinout Bexorg Inc., which is rethinking CNS drug discovery with a whole-human-brain model, and another on Elkedonia S.A.S., a French start-up aiming at ELK1 to reboot neuroplasticity in depression. View full story: https://www.biocentury.com/article/658189 00:00 - Introduction 03:14 - Speeding China's Innovation 10:36 - Neuro Catalysts 22:01 - Newcos To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The biotech bull is back, and buysiders believe this market has staying power for the first time in nearly five years. On a special episode of the BioCentury This Week podcast, Director of Biopharma Intelligence Stephen Hansen and colleagues discuss Hansen’s 2026 Public Markets Preview, which found interest rates, policy in Washington and fundamentals finally aligning and a wave of launches and M&A that could keep capital flowing into the sector. View full story: https://www.biocentury.com/article/658154 #BiotechBullMarket #PublicMarkets #BiotechMA #IPOOutlook #FDApolicy 00:00 - Introduction 00:41 - Market Sentiment 07:55 - Biotech's Next Wave 14:47 - Lingering Concerns 23:29 - IPOs 26:47 - M&A To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Next-generation induced proximity technologies are coming of age after a decade of industry focus on PROTACs. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Senior Biopharma Analyst Danielle Golovin’s four-part analysis of how next-generation targeting chimeras (TACs) are evolving. The analysts assess the $2.2 billion takeout of Rapt Therapeutics by GSK, which gave the pharma an allergy asset that the biotech sourced in China in 2024, and movement in Washington on priority review vouchers, NIH’s budget and the White House’s “most favored nation” drug pricing policy. The analysts also discuss takeaways from their meetings on the sidelines of the J.P. Morgan Healthcare Conference. View full story: https://www.biocentury.com/article/658112 #InducedProximity #TargetingChimeras #BiotechMA #DrugPricingPolicy #JPMHealthcare 00:00 - Introduction  03:17 - JPM Highlights 09:17 - GSK's Acquisition of RAPT 14:46 - Next-Generation Targeting Chimeras 21:41 - MFN and Pediatric PRVs To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The J.P. Morgan Healthcare Conference kicked off this week with sunny skies over San Francisco and more financial momentum than the biotech industry has seen in years. On a special “on the road” edition of the BioCentury This Week podcast, recorded on the sidelines of the annual JPM conference, special guests joined BioCentury’s analysts to discuss the biotech ecosystems in Asia. The wide-ranging conversation spans dealmaking, including the pricing dynamics of assets in China and RNAi’s prospects of becoming the region’s next hot modality; plus the state of the capital markets, the global implications of “China speed” in the clinic, and what’s changing for start-ups in Japan. Joining BioCentury were Panacea Venture’s James Huang, MayTech Global Investments’ Ingrid Yin, DLA Piper’s Ting Xiao and CBRE’s Matt Gardner. The podcast was recorded at the 12th East-West Healthcare Reception, hosted by BioCentury, MayTech Global and Panacea. View full story: https://www.biocentury.com/article/658081 #JPMHealthcare #AsiaBiotech #ChinaBiotech #RNAiTherapeutics #BiotechCapitalMarkets 00:00 - Introduction 02:02 - Split Screen 2026  05:57 - China's Rapid Progress 08:01 - AI and Biotech 16:58 - Deal Prices 22:56 - Public Markets 28:47 - Innovation Across Asia To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Riding the tailwind of a strong 2H25, the days leading up to biotech’s annual kickoff meeting in San Francisco delivered billions in capital raised and more than two dozen deals announced. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss two of the largest deals announced at the start of the J.P. Morgan Healthcare Conference, a partnership for a bispecific between AbbVie and RemeGen and the launch of “NewCo” AirNexus Therapeutics by Haisco Pharmaceutical and a syndicate led by Frazier Life Sciences. The analysts also discuss Washington Editor Steve Usdin’s policy outlook for the year ahead, and Executive Director of Biopharma Intelligence Lauren Martz’s analysis of trends in FDA’s 2025 approvals. View full story: https://www.biocentury.com/article/658052 #JPMHealthcare #BiotechFinancing #BiopharmaPartnerships #FDAApprovals #BiotechPolicy 00:00 - Introduction 01:55 - JPM Deals 11:49 - Policy Outlook 19:30 - Trends in Drug Approvals To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The New Year begins with biotech running along parallel storylines. There’s cause for optimism as the industry’s financing gears have begun to churn again and innovation remains as strong as it has ever been, while there's cause for concern as the world’s most stable, progressive, science-based regulatory system has become unpredictable amid new leadership at HHS, FDA, and NIH. On the first episode of the BioCentury This Week podcast’s seventh year, BioCentury’s analysts assess the state of play for biotech in the U.S., Europe, and Asia. The discussion ranges from recent changes at NIH to what’s next for rare pediatric disease priority review vouchers, and from Europe’s opportunity as FDA enters uncertain terrain to Japan’s evolving biotech landscape. Early bird rates for BioCentury and BayHelix’s fifth East-West Biopharma Summit end Friday. Act now to join investors, dealmakers and innovators in Seoul this March to source innovation from Asia, or accelerate your own pipeline by finding the right Asia partner. View full story: https://www.biocentury.com/article/657978 #BiotechOutlook #FDAUncertainty #GlobalBiotech #RarePediatricDiseasePRV #NIHLeadership 00:00 - Introduction 01:46 - 2026 Outlook 03:56 - Policy Landscape 11:48 - Priority Review Vouchers 15:03 - Global Perspectives 16:57 - Spotlight on Japan 21:55 - European Biotech Opportunities To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

This past year was an inflection point for biotech: The markets woke up, M&A and China had strong showings, drug development offered key trends, and new leadership at FDA shuffled the regulatory deck. On the latest BioCentury This Week podcast, BioCentury’s analysts make their picks for the biggest biopharma readouts, deals and regulatory and policy moves of 2025 and what they are forecasting for the year ahead. The analysts also recap biotech highlights of the past two weeks, including the $4.8 billion takeout of Amicus Therapeutics by BioMarin Pharmaceutical. View full story: https://www.biocentury.com/article/657933 #BiotechOutlook2026 #BiopharmaTrends #BiotechMA #FDALeadership #ChinaBiotech 00:00 - Introduction  02:31 - BioMarin's $4.8B Amicus Deal 06:07 - Year-end Biotech Highlights 16:37 - Analyst Picks and Predictions 30:01 - Policy and Regulatory Landscape To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Obesity readouts continue to be hot for biotech with new top-line data from both injectable and oral therapies pushing the boundaries on efficacy. On the latest BioCentury This Week podcast, BioCentury’s analysts break down last week’s readouts from Eli Lilly, Structure  and Wave Life Sciences, and discuss a deal in the space by Pfizer. Lilly reported the latest for its triple agonist contender retatrutide for best-in-class weight loss, while strong Phase IIb data put Structure back in the oral GLP-1 race. Meanwhile, Pfizer added an oral GLP-1R agonist via a deal). Structure and Wave parlayed their data into follow-on cash, as did Kymera after posting data for its STAT6 program KT-621 that hints at a new era for degraders in immunology. The analysts then detailed the results of BioCentury’s industry sentiment survey on FDA, which found that politicization of the agency’s leadership, volatility and uncertainty are casting a long shadow over investor and drug developer sentiment. Finally, they discuss the impact of the congressional stalemate over the U.S. Small Business Innovation Research (SBIR) program. View full story: https://www.biocentury.com/article/657880 #ObesityDrugDevelopment #TargetedProteinDegradation #STAT6 #FDARegulation #SBIRFunding 00:00 - Introduction 01:45 - Obesity Data 12:17 - Kymera's Breakthrough 21:45 - FDA Survey Results 29:41 - SBIR Funding Stalemate To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Fueled by cancer, obesity and cardiovascular deals, $1 billion-plus takeouts in biotech are at their highest level in a decade with three weeks to go in the year. On the latest BioCentury This Week, BioCentury’s analysts discuss the rise in large M&A deals and what the trends among the 37 acquisitions say about biopharma dealmaking. The analysts assess first-in-human in vivo CAR T data at the American Society of Hematology meeting from Kelonia Therapeutics, which showcase the promise of the modality and justify the growing pipeline. They also break down readouts from Praxis in developmental and epileptic encephalopathy from the American Epilepsy Society Annual Meeting and from Novo Nordisk, which presented full data at the Clinical Trials on Alzheimer’s Disease meeting on semaglutide’s failure to treat Alzheimer’s disease. Washington Editor Steve Usdin analyzes a roller-coaster week at FDA in which Richard Pazdur resigned as director of FDA’s Center for Drug Evaluation and Research and Tracy Beth Høeg became acting CDER director, a move that Usdin says will prompt staff departures, ease restraints on FDA leaders View full story: https://www.biocentury.com/article/657781 #BiotechMA #CARTTherapy #EpilepsyResearch #AlzheimersDisease #FDA 02:37 - Biotech M&A 06:39 - In vivo CAR T 10:08 - Semaglutide for Alzheimer's 16:17 - Praxis 22:11 - FDA To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Novo Nordisk’s highly anticipated data for semaglutide in Alzheimer’s dashed hopes that the GLP-1 therapy could become a game changer in the disease. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses the Phase III readout including what it says about the mechanism’s use in the neurodegenerative disease, Novo’s decision to skip Phase II and enroll a large patient group in a later stage trial, and what other datasets for GLP-1s in the indication have shown. Washington Editor Steve Usdin explains why FDA’s new vaccine policies, driven by CBER Director Vinay Prasad, could have impacts more far-reaching than expected, including making it more difficult to develop or modify vaccines. And Lauren Martz, Executive Director of Biopharma Intelligence, analyzes the bleak investment outlook for cell and gene therapy companies in the U.S. and why China’s biotech ecosystem offers a glimmer of hope for sponsors of these assets. View full story: https://www.biocentury.com/article/657721 #Semaglutide #GLP1Therapies #VaccinePolicy #CellAndGeneTherapy #AlzheimersResearch 00:00 - Introduction 01:53 - Novo's Alzheimer’s Miss 13:19 - FDA's New Vaccine Policy 19:53 - Funding C&GT Biotechs To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

A baffling decision by FDA to issue a complete response letter for a pediatric medicine the medical community stood behind is just the latest example raising concerns that the agency is shifting the regulatory goalposts amid a lack of transparency. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains how the absence of advisory committee meetings at FDA is in part to blame for a lack of consistency in decision-making and divergence from decisions taken by other global regulatory agencies. VP and Editor-in-Chief Simone Fishburn then discusses the takeaways from Franck Le Deu’s guest commentary on how China’s biotech ecosystem is evolving, and whether government support for the sector is helping or hindering its overall health. BioCentury’s analysts also discuss whether conventional CRISPR therapies will ever be commercially successful, and what’s next for NLRP3 inhibitors to treat obesity following the first set of Phase II data for the class. We'd also like to invite our listeners to participate in our important survey about their experiences interacting with FDA. To take the survey, please go to BioCentury's FDA Sentiment Survey. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics. View full story: https://www.biocentury.com/article/657698 #FDARegulation #CRISPRTherapies #NLRP3Inhibitors #ChinaBiotech #DrugApproval 00:01 - Sponsor Message: Voyager Therapeutics 01:31 - FDA Sydnexis CRL 07:36 - CDC Vaccine Claims 09:55 - China’s Innovation Arc 16:49 - CRISPR Commercial Viability  26:39 - NLRP3 for Obesity To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

There is cautious optimism around continued M&A momentum and the public equities markets as biotech heads into the New Year. On a special edition of the BioCentury This Week podcast recorded in London during London Life Sciences Week, BioCentury’s Simone Fishburn and Stephen Hansen were joined by a trio of guests to discuss their key takeaways from the week and expectations for next year, including trends in M&A and creative deal structures for business development. The group also discussed the potential for biotech venture investing to make a comeback as a key asset class for LPs, especially in the U.K., as the government continues to encourage pension funds to invest more broadly. The three guests joining BioCentury included Luciana Griebel from law firm Morgan Lewis, James Critchley from PJT Partners, and Carmine Circelli from the British Business Bank. The podcast was recorded Nov. 19 on stage at the Victoria House in London as part of the 3rd Biotech CEO & Investor Reception. BioCentury’s next recording “on the road” will take place on the sidelines of the annual J.P. Morgan Healthcare Conference in San Francisco in January at the 11th East West Healthcare Reception hosted by BioCentury, Panacea Venture and Maytech Global Investments. View full story: https://www.biocentury.com/article/657686 #BiotechMandA #DrugDevelopment #VentureCapital #LifeSciences #LondonLifeSciencesWeek 00:00 - Introduction 02:24 - Market Recovery 08:02 - Growth and Influence 16:24 - Creative Dealmaking 21:40 - Role of CVRs 25:52 - Pension Funds and Venture Capital 30:09 - AI Bubble 34:17 - Accelerating Clinical Trials Morgan Lewis has prepared its materials for this podcast for general informational purposes only. They do not and are not intended to constitute legal advice. This podcast was recorded on Nov. 19. Morgan Lewis does not guarantee the accuracy or timeliness of the information contained in these materials and disclaims any obligation to advise you of any changes in the law. You should always refer to original source documents for complete information and consult directly with an attorney for advice, including on the latest developments in this rapidly changing area of the law. To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Voyager CEO and former head of R&D at Biogen Al Sandrock is more optimistic than ever about the prospect of bringing clinically meaningful solutions to patients with Alzheimer’s disease and other neurodegenerative disorders. The threads of progress are finally coming together, he said in a special episode of the BioCentury This Week podcast. From the first disease-modifying therapies for Alzheimer’s disease, to a growing biomarker toolkit, to an expanding set of genetically validated targets in other neurodegenerative conditions — and, crucially, to delivery vehicles capable of broadly and deeply penetrating the brain — neurology drug development may be poised to accelerate. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics. View full story: https://www.biocentury.com/article/657678 #AlzheimersDisease #AAVGeneTherapy #BloodBrainBarrier #TauTargeting #Neurodegeneration 00:01 - Sponsor Message: Voyager Therapeutics  03:41 - Voyager's Approach to Gene Therapy 15:07 - Alzheimer's Disease 25:25 - Big Biotech to Small Biotech 29:21 - Neurodegenerative Diseases 31:19 - FDA Flexibility To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Richard Pazdur took the top job at FDA’s Center for Drug Evaluation and Research after receiving vows that he would be leading CDER free from political interference. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the issues that could prove to be flashpoints between Pazdur and the heads of FDA and HHS, including personnel, RSV mAbs, puberty blockers and SSRIs. BioCentury's analysts assess bispecific innovation at the annual meeting of the Society for Immunotherapy of Cancer (SITC) and the growing field of companies pursuing RNAi, many of which have multiple unpartnered assets. Also featured in this week's episode: new funds from European VCs Medicxi and Sofinnova Partners, FDA’s new plausible mechanism pathway and the Trump administration’s “most favored nation” drug-pricing plan, which is turning out to be much more less onerous to drug companies than its original description suggested. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics. View full story: https://www.biocentury.com/article/657631 #RNAiTherapeutics #BispecificAntibodies #CD3TCellEngagers #MechanismOfAction #ImmunoOncology #PlausibleMechanismPathway #RegulatoryScience #ClinicalTranslation 00:01 - Sponsor Message: Voyager Therapeutics  03:08 - FDA's Richard Pazdur 13:08 - Plausible Mechanism Pathway 19:30 - Most Favored Nation 23:12 - Takeaways from SITC 28:05 - RNAi in China 33:21 - European VCs To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Today’s South Korean biotechs have a risk-on mentality, a willingness to partner, and strategies focused on globalization. On a special edition of the BioCentury This Week podcast recorded at Venture Café Cambridge, BioCentury is joined by a quartet of investors and executives with deep knowledge of Korea’s life sciences ecosystem to discuss Korea biotech’s push to globalize and the opportunities in the country for Western companies. The four guests joining BioCentury were Aram Hong, CEO of Korean start-up Apollon; investors Spencer Nam and Debra Peattie; and Boehringer Ingelheim GmbH's Andy Whittle. The podcast was recorded Nov. 6 on stage at the Venture Café Cambridge during the K-Blockbuster Night hosted by KHIDI, the Korea Health Industry Development Institute. BioCentury analyses discussed during the podcast include one on Asian deals and another on the speed of clinical trials in China. BioCentury returns to Asia early next year for the 5th East-West Summit, March 9-11 in Seoul. This episode of the BioCentury This Week podcast is brought to you by KHIDI. View Full story: https://www.biocentury.com/article/657558 #KoreaBiotech #Globalization #LifeSciences #BiotechEcosystem #PharmaDeals #ClinicalDevelopment #Innovation #BiotechLeadership 00:01 - Sponsor Message: KHIDI 05:08 - Asia Deals and Korea's Role 09:12 - Boehringer's Perspective 13:51 - Apollon's Journey 17:24 - Building Relationships 23:20 - Investors' View  To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

With ObesityWeek yielding eye-catching amylin data and a bidding war that ran to $10 billion for Metsera, weight loss companies were center stage in biotech last week. On the latest edition of the BioCentury This Week podcast, BioCentury’s analysts explained why Pfizer's victory for the start-up over European rival Novo Nordisk doesn’t necessarily mean a broader U.S. policy shift against foreign acquisitions of domestic biotechs. Turning to ObesityWeek readouts, they discuss Eli Lilly's data for amylin monotherapy eloralintide, arguing that just as Lilly did with GLP-1 agonists, the company is again setting the benchmark by which all other molecules in the class will be measured. BioCentury's analysts also discuss takeaways from Washington Editor Steve Usdin's Commentary, which finds FDA in a crisis of politicized decisions, plummeting morale, and a hollowed workforce, and highlights from BioCentury's interview with gene therapy pioneer Jim Wilson as he rethinks the funding model for ultrarare disease therapies to keep his mission on track. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics. View full story: https://www.biocentury.com/article/657545 #ObesityWeek #Amylin #GLP1 #Eloralintide #DrugMechanism #FDA #RareDisease #GeneTherapy 00:01 - Sponsor Message: Voyager Therapeutics  01:53 - Pfizer Wins Metsera 08:48 - Lilly's Amylin Data 13:06 - Funding Ultrarare Therapies 20:51 - What's Next for FDA To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Novo Nordisk’s unsolicited $8.5 billion bid for Metsera has thrown a wrench into Pfizer’s plans to return to the obesity race via its acquisition of the New York-based start-up. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the details of the competing bids and what’s at stake for the pair of suitors. The analysts also assess the reasons behind the abrupt departure of Center for Drug Evaluation and Research Director George Tidmarsh from FDA and a surge in activity on the Hong Kong stock exchange. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics. View full story: https://www.biocentury.com/article/657475 #Biotech #PharmaDeals #ObesityDrugs #MergersAndAcquisitions #FDA #LifeSciences #GlobalBiotech #HongKongMarket 00:01 - Sponsor Message: Voyager Therapeutics 01:53 - Metsera M&A 15:23 - Tidmarsh Ouster 25:12 - Hong Kong IPOs To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

China is setting a new bar for the speed of clinical development and redefining the time it takes an asset to get to the clinic. On a special edition of the BioCentury This Week podcast recorded on stage at the 12th BioCentury BayHelix China Healthcare Summit in Shanghai, BioCentury's Simone Fishburn argued that China’s emerging new standard for swift entry to the clinic could upend the bottleneck of translational development and usher in a new paradigm that could have a “massive impact globally.” Fishburn and her BioCentury colleagues Joshua Berlin and Jeff Cranmer were joined by a trio of cross-border KOLs — John Zhu, CEO of antibody-drug conjugate company DualityBio; Matt Hewitt, CTO of  Charles River Laboratories' manufacturing business division; and Bing Wang, CFO of Akeso — to discuss the speed of generating first-in-human data, Innovent’s $1.2 billion deal with Takeda, an evolving biotech talent pool, and the state of the financial markets. “For me, it really feels like 2025 is the year that biotech globally woke up to China,” Fishburn said. BioCentury returns to Asia early next year for the 5th East-West Summit, March 9-11 in Seoul. Register today as a delegate or apply to join the Presenting Company Class to take advantage of early bird rates. #ChinaInnovation #DrugDevelopment #PharmaDeals #GlobalBiotech #PharmaInnovation #siRNA #BrainToVein 00:00 - Introduction 02:49 - China Speed 12:27 - Clinical Trails  17:34 - Global Strategy 26:59 - Financial Markets IPOs 36:52 - Talent To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Novartis’ biggest deal in more than a decade gives the Swiss pharma three programs for muscular dystrophies that are close to the finish line. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the $12 billion deal for Avidity in the context of Novartis’ recent acquisitions and the antibody-oligonucleotide conjugate platform it is gaining. The team dives into RNA versus DNA modalities, noting antisense and siRNA approaches appear to be gaining traction with major pharmas as traditional gene therapy and gene editing approaches hit rocky times. Still, they note hopeful progress among base editing therapies given the promising early track records of over a dozen base editors in the clinic. They also discuss BioCentury’s conversation with base editing inventor David Liu; Alkermes’ $2.1 billion acquisition of Avadel; and β-catenin data from Parabilis. This episode of BioCentury This Week is sponsored by Evotec. View full story: https://www.biocentury.com/article/657412 #AntibodyOligonucleotideConjugates #RNAtherapeutics #BaseEditing #MuscularDystrophy #WntPathway #BetaCatenin #Orexin2Receptor #PrecisionMedicine 00:01 - Sponsor Message: Evotec  02:04 - 12th China Healthcare Summit 08:11 - Novartis' $12B Deal 16:58 - Alkermes M&A 20:01 - David Liu Base Editing 25:02 - Parabilis' Data To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Next-generation platforms and technologies are getting closer to cracking one of biopharma’s biggest problems: delivering medicines, and mAbs in particular, to the brain. On the latest BioCentury This Week podcast, BioCentury’s Selina Koch details the latest innovations in blood-brain-barrier shuttles and how the technologies could transform the treatment of neurological diseases. BioCentury’s Lauren Martz discusses her conversation with Tony Wood, CSO of GSK, which included the pharma’s strategy for indication expansion, why it prefers RNA modalities over AAV-based gene therapies, and how its quest for causal biology has evolved over the years. Washington Editor Steve Usdin discusses the first set of FDA’s new commissioner’s national priority review vouchers, and why the voucher program is unlikely to function as an incentive capable of steering future behavior. Usdin also discusses the potential impact of FDA staffing reductions on the sector. This episode of BioCentury This Week is sponsored by Evotec. View full story: https://www.biocentury.com/article/657326 #BloodBrainBarrier #Neurology #DrugDelivery #MonoclonalAntibodies #RNAtherapeutics #CausalBiology #FDA 00:01 - Sponsor Message: Evotec 01:57 - Brain Shuttles 13:57 - GSK Q&A 20:08 - FDA Vouchers To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

It’s been a tough year for cell and gene therapy — patient deaths, high-profile companies pulling out of the space, and sour investment sentiment. But the field has had some promising readouts in the clinic recently, and it continues to mature, showing steady progress despite challenging market conditions. On the latest BioCentury This Week podcast, Evotec’s Bernd Mühlenweg joins BioCentury’s analysts to give his view of the field and offer takeaways from this month’s Cell & Gene Meeting on the Mesa in Phoenix. This episode of BioCentury This Week is sponsored by Evotec.  View full story: https://www.biocentury.com/article/657278 To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Biotech’s fourth quarter began with a familiar feeling, with indicators pointing toward an improving public market even as political and regulatory uncertainty has buysiders reluctant to say industry has returned to sustainable growth. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the state of biotech’s public markets. The analysts discuss the Senate’s move to limit access to Chinese CDMOs, the latest developments in the White House’s “most favored nation” drug pricing negotiations, and the U.K.'s attempt to win over pharma companies via adjusting thresholds at NICE. Finally, they analyze a pair of billion-dollar-plus M&A deals: the $4.7 billion deal by Novo Nordisk to acquire liver disease company Akero and the $1.5 billion takeout of in vivo cell therapy company Orbital by Bristol Myers. This episode of BioCentury This Week is sponsored by Evotec. View full story: https://www.biocentury.com/article/657260 #biotech #biopharma #pharma #lifescience #drugpricing #MFN 00:01  Sponsor Message: Evotec 02:12  4Q Markets Preview 13:25  China CDMOs 24:35  Drug Pricing Deals NHS 31:22  Drug Pricing Deals M&A To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The short-term consequences for Pfizer from its “most favored nation” drug pricing deal with the White House are negligible, but the long-term effects on the industry could be profound and permanent. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses why the deal by Pfizer Inc. (NYSE:PFE) changes everything — and nothing — and what’s next in wrangling over drug pricing between industry and the Trump administration. The analysts also discuss PDUFA negotiations between FDA and leaders of BIO and PhRMA, how multi-site IITs could help bridge the academia-industry gap, and how TCG X plans to deploy its new $1.3 billion fund. This episode of BioCentury This Week is sponsored by Evotec. View full story: https://www.biocentury.com/article/657192 #biotech #biopharma #pharma #lifescience #financialmarkets #drugpricing #MFN 00:01  Sponsor Message: Evotec 03:31  Pfizer MFN Deal 16:05  PDUFA Reauthorization 20:31  Investigator-Initiated Trials To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Genmab's $8 billion acquisition of multispecifics company Merus is the Danish biotech’s largest step toward marketing its own pipeline. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the evolution of Genmab, which, for many years, relied on a partnership model that delivered blockbuster revenues but now is making a change as a patent cliff looms. The analysts also assess the tenure of Emma Walmsley the longtime CEO of GSK, and what’s next for the U.K. pharma under incoming CEO Luke Miels. Turning to the U.S., Washington Editor Steve Usdin discusses President Donald Trump’s looming tariff threat on imports of branded drugs, which Usdin says would hurt small biotechs the most. Usdin also analyzes the response of multinational pharmaceutical companies to the president’s demand that they make “most favored nation” price concessions, now that Monday’s deadline has passed. This episode of BioCentury This Week is sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/657131 #biotech #pharma #deals #FGF21 #MASH #Interleukin5 #asthma #PhRMA #PBM #tarriff #MFN 00:01 - Sponsor Message: IQVIA Biotech 02:26 - Genmab's Merus Buy 09:43 - CEO Switch at GSK 17:22 - Trump Tariff Threat 21:17 - MFN Drug Pricing To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

AI is bringing sweeping changes to drug development, from how targets are discovered to optimizing clinical trials to maximize an asset’s chance for success. On a special edition of the BioCentury This Week podcast, IQVIA’s Greg Lever joins BioCentury’s analysts to discuss agentic AI’s short- and long-term prospects to help biotechs discover new targets, predict success in preclinical development, and enhance clinical operations. This episode of BioCentury This Week is sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/657086 #Biotech #Biopharma #DrugDevelopment #ClinicalTrials #TargetDiscovery #AgenticAI #GraphRAG #DeRisking 00:01 - Sponsor Message: IQVIA Biotech 01:22 - AI in Biotech 05:01 - Machine Learning 06:21 - Generative AI and Language Models 08:37 - Agentic AI 12:43 - AI in Target Discovery 23:44 - AI in Clinical Trial Design To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Is this the U.K.’s moment to capitalize on its biotech ecosystem? That was one of the primary themes discussed at the debut Grand Rounds — Europe conference last week in Cambridge, U.K. BioMarin's James Sabry and Astex's Michelle Jones joined BioCentury’s analysts on a special edition of the BioCentury This Week podcast recorded live at the event to discuss their key takeaways from the two-day conference. Beyond the state of the U.K. biopharma ecosystem, the analysts discussed the meeting’s major science themes, including what’s next for DNA damage repair pathway targets, both inside and outside of cancer; whether obesity should be recast as a brain disease; and the cutting edge of small molecule design. View full story: https://www.biocentury.com/article/657082 #UKBiotech #TranslationalMedicine #DrugPricing #GlobalCollaboration #Aging #Biologics #SmallMolecules #Biobanking 00:00 - Introduction 00:35 - Key Takeaways 02:14 - The State of the U.K. Biotech Ecosystem 09:01 - Scientific Highlights & Panel Takeaways 22:44 - Closing Remarks and Future Events To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

A takeout that could be worth as much as $7.3 billion has Pfizer back in the obesity drug development race. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Pfizer’s acquisition of Metsera and its obesity assets. Plus: Editor in Chief Simone Fishburn gives a recap of BioCentury’s Grand Rounds — Europe meeting, which included a fireside chat with Patrick Vallance on the state of the life sciences ecosystem in the country. The BioCentury analysts also assess the state of hot-button policy issues in Washington, such as drug pricing and China. Finally, they analyze the state of play among therapies for narcolepsy on the heels of the World Sleep Congress in Singapore. Check out BIO Chairman Fritz Bittenbender’s conversation with BioCentury Washington Editor Steve Usdin on BioCentury This Week’s sister podcast, The BioCentury Show. This episode of BioCentury This Week is sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/657065 #ObesityDrugs #PharmaDeals #BiotechDeals #MergersAndAcquisitions #DrugDevelopment #Narcolepsy 00:01 - Sponsor Message: IQVIA Biotech 03:46 - Pfizer’s Obesity M&A 14:54 - U.K. in Focus 28:20 - U.S. Drug Pricing, China Policy 40:07 - Narcolepsy Pipeline To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Merck's announcement that it is moving its R&D out of the U.K. highlights concerns about the country’s life sciences policies. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the life sciences ecosystem in the U.K., including MHRA CEO Lawrence Tallon’s plans to create a world-class regulatory environment. They also discuss a bill passed by the U.S. House of Representatives that would end most U.S.-China academic research collaborations, and the recent success of 40-year-old biotech Insmed. This episode of BioCentury This Week is sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/656997 #biotech #biopharma #pharma #lifescience #MHRA #China #RandD #DrugDevelopment 00:01 - Sponsor Message: IQVIA Biotech 01:25 - U.K. Biopharma 04:40 - Grand Rounds Cambridge 09:45 - SAFE Research Act 18:01 - Spotlight on Insmed 26:32 - Sen. Cassidy's Vaccine Callout To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Molecular biologist and Nobel Prize winner David Baltimore made foundational contributions to the biopharma industry and was the essential figure behind such research institutions as the Whitehead Institute for Biomedical Research and the Broad Institute. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the legacy of Baltimore, who passed away this past weekend at 87. The analysts also discuss Atlas Venture’s new $400 million opportunity fund, the clinical development pipelines for metabolic-associated steatohepatitis (MASH) and chronic urticaria, and late-stage atopic dermatitis data from Sanofi. This episode of BioCentury This Week is sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/656942 #biotech #biopharma #DavidBaltimore #ReverseTranscriptase #MASH #Rezdiffra #GLP1 #ChronicUrticaria #Dupixent 00:01 - Sponsor Message: IQVIA Biotech 03:19 - Remembering David Baltimore 06:26 - Atlas's New Opportunity Fund 09:22 - The Growing MASH Pipeline 16:03 - Sanofi's Atopic Dermatitis Data 18:57 - Exploring Chronic Urticaria Treatments To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Two veteran biotech leaders are launching a new company with ambitions in the cardiovascular disease space. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the debut of Corsera Health, a biotech led by John Maraganore and Clive Meanwell that is developing an AI-guided early risk assessment tool alongside dual-acting therapy that could stave off heart disease. The team then discusses how FDA has been quietly positioning itself to disrupt the childhood vaccine schedule, as well as the effects of changes to the Medicare drug negotiation program that were included in the tax and budget bill Congress passed in July. View full story: https://www.biocentury.com/article/656897 #Corsera #DiseaseInterception #CardiovascularHealth #HeartDisease #FDA #VaccinePolicy #Medicare #DrugPricing 00:00 - Introduction 01:26 - Maraganore, Meanwell Newco 09:17 - BioCentury's Back to School 14:51 - Vaccine Disruption at FDA 26:01 - Medicare Drug Negotiations To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

There’s been a rare IPO filing on NASDAQ as LB Pharma looks to test the market during a year that has seen little activity among U.S. biotechs even as green shoots continue to appear on the Hong Kong stock exchange. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for biotech IPOs on NASDAQ and in Hong Kong. The analysts then assess FDA’s about-face on Stealth BioTherapeutics' Barth syndrome therapy, putting the decision in the context of a changing regulatory agency; and a BioCentury Guest Commentary that argues that the university-industry engine that drives U.S. innovation is under attack. Also mentioned on this week’s podcast: BioCentury’s 33rd Back to School package, which reimagines FDA; the upcoming 12th China Healthcare Summit in Shanghai; the evolution of dealmaking in China; and Annalisa Jenkins’ take on MHRA and the U.K. biotech ecosystem on The BioCentury Show. View full story: https://www.biocentury.com/article/656849 #Biotech #IPO #Pharma #FDA #RareDisease #Biopharma #DrugDevelopment #HealthcareInnovation #HongKongIPO 00:00 - Introduction  02:48 – LB Pharma Tests IPO Market 07:01 – Hong Kong IPO Momentum 09:53 – China Summit Preview 13:40 – FDA Reversal on Stealth Bio 18:15 – Bayh-Dole Clash & Innovation Threats To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

BioCentury’s third annual analysis of pharma company deals finds that bispecifics and degraders are in, cell and gene therapies are out, and China is bringing much more than me-too assets to cross-border deals. On the latest BioCentury This Week podcast, BioCentury’s analysts assess a year’s worth of deals between pharmas and biotechs to tease out emerging trends. The analysts also discuss last week’s FDA approval of a vector-based immunotherapy from Precigen to treat a rare respiratory disease and whether the decision will set a precedent of more flexibility for rare disease therapies. They then take stock of recent translational coverage in BioCentury, including a report by Denali of a way to avoid a key safety issue of anti-amyloid-targeting mAbs. BioCentury’s Grand Rounds — Europe will take place in Cambridge, U.K., Sept. 17-19. The conference seeks to bridge academia, industry and investors for breakthrough innovation. View full Story: https://www.biocentury.com/article/656802 #PharmaDeals #CrossBorderDeals #Bispecifics #TargetedProteinDegradation #RareDisease #Neurodegeneration 00:00 - Introduction 01:38 - Pharma Deals 10:41 - Precigen 14:40 - Denali's BBB Tech 25:20 - Grand Rounds Europe To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Dealmaking between Western and Chinese biopharmas has been one of the year’s bright spots, as a maturing biotech landscape in China converges with Western demand for innovative assets, driving record deal flow. At the same time, the Hong Kong stock exchange has emerged as the hottest market for biotech IPOs, at a time when the NASDAQ window remains shut. These themes will be in the spotlight at the 12th BioCentury-BayHelix China Healthcare Summit Oct. 22-24 in Shanghai. On this special edition of the BioCentury This Week podcast, a trio of biopharma leaders join BioCentury’s analysts to discuss the landscape: McKinsey's Franck Le Deu, former BD executive Ji Li, and HBM Holdings' Mike Patten. BioCentury, BayHelix and Insights Partner McKinsey & Company invite you to visit Shanghai for the 12th China Healthcare Summit at the St. Regis Shanghai Jingan. For more information, click here; to apply to join the 2025 Class of Presenting Companies click here. View full story: https://www.biocentury.com/article/656773 #ChinaBiotech #CrossBorderDeals #HongKongIPO #BiotechInvesting #LifeSciencesFinance 00:00 - Introduction 02:09 – Key Trends 06:03 – View from McKinsey 13:36 – Evolution of Deal Landscape 20:24 – Learning from China 24:00 – China-China M&A & NewCos To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Phase III data from Lilly’s orforglipron in obesity fell short of investor expectations, but they appear to be enough to obtain approval and wide use. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss why the first-in-class oral small molecule GLP-1R agonist’s clean safety profile and clear manufacturing advantage over oral peptides give the product a leg-up in the market. They then discuss Vinay Prasad’s return to FDA after a brief hiatus, the revamped strategy of 32-year-old San Diego biotech Acadia Pharmaceuticals, and an attempt in the Senate to revive the Biosecure Act targeting China biotechs. Finally, the analysts preview this year’s Back to School package, which reimagines FDA. At a time of unprecedented change in government agencies, BioCentury’s 33rd Back to School asks what FDA could look like if it were reorganized from the ground up to create the regulator patients deserve and industry needs. View full story: https://www.biocentury.com/article/656727 #orforglipron #CBER #VinayPrasad #AcadiaPharmaceuticals 00:00 - Introduction 00:49 - Prasad 07:09 - Back to School 12:29 - Lilly Obesity 21:58 - Acadia's Comeback 28:50 - Biosecure Act To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The ouster of Vinay Prasad after three months running FDA’s Center for Biologics Evaluation and Research could signal a reset is ahead for CBER. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what the latest shakeup at the regulatory agency says about what’s next for FDA. The analysts also assess two leading European pharmas: obesity and diabetes company Novo Nordisk, which named a new CEO last week while cutting its 2025 forecast, and Bayer, which is gearing up for launches and is revamping its pipeline to restart growth. Finally, they discuss the promising clinical data that’s reviving interest in masking technologies that conditionally activate biologics. View full story: https://www.biocentury.com/article/656649 #FDA #CBER #NovoNordisk #ObesityDrugs #Bayer 01:05 - Prasad's Ouster 14:59 - Novo's New CEO 21:14 - Bayer's Growth Strategy 26:05 - Masked Biologics To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

A handful of encouraging signals is cause for cautious optimism for biotech headed into the second half of the year — companies have been able to parlay strong data into follow-on capital and M&A activity is picking up. That said, the IPO market continues to be closed and concerns about U.S. drug pricing and FDA stability continue to weigh on expectations for a robust near-term sector recovery. Special guest Megan Hooton from IQVIA Biotech joins BioCentury’s analysts on a special edition of the podcast to discuss key indicators of progress for the biopharma sector. Hooton is president of IQVIA Biotech, which sponsored this episode of the pod. View full story: https://www.biocentury.com/article/656614 #biotech #biopharma #pharma #lifescience #BiotechTrends #ClinicalTrials #GeneTherapy #CellTherapy 00:01 – Sponsor Message: IQVIA Biotech 02:37 – Biotech Markets 06:41 – Clinical Highlights 10:26 – Insights from Meg Hooton 23:10 – Advanced Therapies To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

This week’s deal between GSK and Jiangsu Hengrui is a prime example of how Western biopharmas have begun to recognize the innovation and opportunities being fostered in China — and how it’s no longer all about fast followers. On the latest BioCentury This Week podcast, BioCentury’s analysts put the collaboration between GSK and Jiangsu Hengrui Pharmaceuticals, two of the most active cross-border dealmakers, into the context of East-West dealmaking over the past 30 months, assessing the innovation that is driving the rush to partner with biotechs in China, Japan, South Korea and beyond, and the types of companies looking to Asia for assets. BioCentury’s analysts also discuss Steve Bates’ outsized role in building the U.K. biotech hub, as he readies to take on a new role in the U.K. government. They examine new VC funds from Omega Funds and Brandon Capital, FDA’s new national priority voucher pilot program, and fallout from how FDA and  Sarepta Therapeutics handled the deaths of four patients who had received the biotech’s gene therapies. This episode of BioCentury This Week is sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/656592 #biotech #biopharma #pharma #lifescience #EastWestDealmaking #ChinaBiotech #UKBiotech #FDAPolicy 00:01 - Sponsor Message: IQVIA Biotech 02:48 - Asia Deals Landscape 17:32 - Steve Bates & U.K. Biotech 25:46 - FDA's New Voucher Pilot 31:01 - New VC Funds 35:28 - Sarepta To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Last week’s public disclosure that a gene therapy from Sarepta had caused a third death led FDA to ask the company to stop distributing its DMD gene therapy Elevidys, a move the biotech has resisted. The deaths, and disputes between FDA and Sarepta, raise questions about the future of AAV gene therapies, as well as the future of FDA’s platform technology designation. On the latest BioCentury This Week podcast, BioCentury’s analysts unpack the events surrounding Sarepta’s gene therapies and discuss how FDA, industry and patient groups should come together to learn the lessons from the tragic, avoidable deaths. BioCentury’s analysts also assess Monday’s appointment of Stanford professor and biotech executive George Tidmarsh to lead FDA’s Center for Drug Evaluation and Research, and check in on the latest trends in venture financings. This episode of BioCentury This Week is sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/656537 #biotech #biopharma #pharma #lifescience #GeneTherapy #AAVTherapy #Sarepta #Elevidys 00:01 - Sponsor Message: IQVIA Biotech 02:03 - Gene Therapy 17:59 - Leading CDER 27:00 - Venture Report To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Chinese biotech is the lone bright spot for the biopharma financial markets in 1H25, as macro concerns about the most favored nation (MFN) pricing policy and FDA weigh on the prospects for biotech elsewhere. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the positives — and negatives — impacting investor sentiment headed into the second half of the year. The team also discuss where the quantum computing revolution could have its biggest impact on drug development, and review the proposals and accomplishments of FDA Commissioner Marty Makary over his first 100 days in office. This episode of BioCentury This Week was sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/656482 #biotech #biopharma #pharma #lifescience #financialmarkets #FDA #quantumcomputing 00:01 - Sponsor Message: IQVIA Biotech 04:43 - Q25 Financial Markets Preview 22:20 - Quantum Computing Impact on Biopharma 30:07 - Makary's First 100 Days To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

There are many reasons why it may be the European biomedical ecosystem’s moment to shine, and advances at the academia-industry interface are a core part of that story, particularly in Cambridge, U.K. — the site of the inaugural BioCentury Grand Rounds – Europe conference. On a special edition of the BioCentury This Week podcast, BioCentury’s analysts are joined by four leaders in the Cambridge, U.K., life sciences community to preview the Sept. 17-19 meeting: Kathryn Chapman, executive director of Innovate Cambridge; Anne Horgan, partner, Cambridge Innovation Capital; Sally Mardikian, business development director, Astrazeneca; and Kristin-Anne Rutter, executive director of Cambridge University Health Partners. The BioCentury team and its Cambridge counterparts discuss the conference’s themes and how they relate to the region’s strengths, and offer both some tough love and a warm invitation to early-stage innovators looking for science-forward investors and partners. View full story: https://www.biocentury.com/article/656373 #biotech #biopharma #pharma #lifescience #Discovery #Translation #BioCenturyGrandRoundsEurope 00:00 - Introduction 01:53 - Grand Rounds Cambridge Themes 10:14 - Why Cambridge? 23:43 - Tough Love 28:02 - Join us at GlastonGeek To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Oncology regulation has been less affected by recent changes in FDA leadership than other parts of the agency. On a special sponsored edition of the BioCentury This Week podcast, BioCentury’s analysts assess what has and hasn’t changed at FDA when it come to regulating cancer therapeutics. Special Guest Liz O’Brien joins BioCentury’s analysts to discuss how biotechs can navigate FDA’s Project Optimus and EMA’s Joint Clinical Assessment as well as the differences between the two agencies. O’Brien is a former EMA regulator who is now therapeutic expert, oncology and women’s health, drug development solutions at BioCentury This Week sponsor ICON Biotech. View full story: https://www.biocentury.com/article/656371 #biotech #biopharma #pharma #lifescience #FDA #cancer #CAR_T 00:01 - Sponsor Message: ICON Biotech 02:30 - FDA Cancer Regulations 07:48 - Project Optimus 25:12 - CAR T REMS Removal To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Treg-based cell therapies are nearing a clinical proof-of-concept inflection point, but in an environment that has dramatically shifted with the advent of CAR T therapies for autoimmune diseases. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what these cell therapies need to show to be relevant in the fast-changing I&I world, and which types of indications may best suit the cells’ unique profile. The team also explores the biotech sector’s ongoing struggle to capture the interest of generalist investors, and what the next major theme might be to draw them back. The analysts then break down the key provisions in the recently passed U.S. reconciliation tax bill, highlighting the positive and negative developments, as well as the missed opportunities for the industry. This episode of BioCentury This Week was sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/656376 #biotech #biopharma #pharma #lifescience #CellTherapy #TregTherapy #CAR_T 00:01 - Sponsor Message: IQVIA Biotech 01:19 - Treg Inflection Point 10:57 - Biotech's Next Big Story 22:36 - Tax Bill Consequences To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The Trump administration’s overhaul of FDA is still underway, but the agency has already veered away from its decades-long trajectory in ways that will profoundly reshape medical product development and the lives of U.S. patients. On the latest BioCentury This Week podcast, BioCentury’s analysts assess who the winners and losers are likely to be as FDA changes shape. The analysts discuss a pair of in vivo CAR T companies: Esobiotec, whose story offers a case study in product-focused strategy, and Capstan Therapeutics, whose in vivo CAR T platform for immunological disorders attracted a buyer in Abbvie. The team also analyzes why data from Compass Pathways for psilocybin therapy COMP360 disappointed investors despite hitting the endpoint, and how molecular glues could be the future of selective CDK2 targeting. This episode of BioCentury This Week was sponsored by ICON Biotech. View full story: https://www.biocentury.com/article/656341 #biotech #biopharma #pharma #lifescience #RandD #drugapproval 00:01 - Sponsor Message: ICON Biotech 02:26 - BioCentury Grand Rounds Europe 05:02 - FDA's Future 15:03 - Psychedelics 22:53 - Esobiotech's Fast Exit 31:37 - Molecular Glues and CDK2 34:43 - Abbvie's Capstan Buy To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Publicly traded U.K. investment firm and company builder Syncona is restructuring its fund amid ongoing market challenges in the biopharma industry. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the firm will steer its portfolio toward returns for shareholders, while aiming to build a new fund away from public markets. The analysts then assess Eli Lilly's takeout of cardiovascular base editing company Verve, and what Washington Editor Steve Usdin calls FDA’s new “two-track” future for evaluating new therapies for approval — those with clear-cut benefits and those with ambiguous efficacy safety and efficacy profiles — in light of the many departures of senior FDA staff. They also discuss NASDAQ’s largest biopharma IPO — by Caris —  in two years, the latest obesity readouts, FDA Commissioner Marty Makary’s priority pathway and Usdin’s Q&A with new BIO Chair Fritz Bittenbender. This episode of BioCentury This Week was sponsored by ICON Biotech. View full story: https://www.biocentury.com/article/656266 #biotech #biopharma #pharma #lifescience #finance #CV #FDA 00:01 - Sponsor Message: ICON Biotech 02:14 - Syncona Restructures Fund 10:08 - Lilly's $1B Verve Takeout 21:45 - FDA's 2-Track Future To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The tragic death of a second non-ambulatory DMD patient treated with Sarepta's Elevidys gene therapy marks a turning point for the field and should drive all stakeholders to come together to figure out how to safely treat patients with this new modality. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the opportunity FDA, companies and patient advocates have to share data and identify a safe path forward for the gene therapy field, both in DMD and beyond. The analysts also review promising early data for amylin agonists to treat obesity from Metsera and Eli Lilly, and discuss the vision for FDA’s future laid out by Commissioner Marty Makary and CBER director Vinay Prasad. This episode of BioCentury This Week was sponsored by ICON Biotech. View full story: https://www.biocentury.com/article/656214 #biotech #biopharma #pharma #lifescience #obesity #FDA #DMD 00:01 - Sponsor Message: ICON Biotech 01:19 - Gene Therapy Safety 11:55 - Amylin in Obesity 18:17 - FDA's Future To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

With federal funding at risk and VCs increasingly focused on de-risked assets, academia is facing unprecedented headwinds despite rapid advancements in innovation. One potential bright spot: Pharma, which is turning to academia to access first-in-class innovation. But many in pharma complain it is difficult to work with academia. On a special Grand Rounds edition of the BioCentury This Week podcast, BioCentury analysts and special guests discuss a new way of thinking and a new era of collaboration between academia and industry. View full story: https://www.biocentury.com/article/656177 #biotech #biopharma #pharma #lifescience #Discovery #Translation #BioCenturyGrandRounds 00:00 - Introduction 02:38 - Key Findings 07:42 - Collaboration and Opportunities 25:52 - BioCentury Grand Rounds Europe To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Translational trends at this year’s ASCO meeting featured new and selective ways to target cell surface receptors on solid tumors. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the findings from Executive Director of Biopharma Intelligence Lauren Martz’s deep dive into first-in-human studies at the American Society of Clinical Oncology meeting, including how immunocytokines, solid tumor CAR Ts and Chinese innovation are thriving in early trials. The analysts also examine the signs of strain and resilience in biotech’s crossover investors, as well as FDA’s plans for revamping rare disease regulation. This episode of BioCentury This Week was sponsored by ICON Biotech. View full story: https://www.biocentury.com/article/656139 #biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment 00:01 - Sponsor Message: ICON Biotech 02:11 - ASCO’s First-in-Human Trials 12:46 - Crossover Investor Health Check 22:54 - FDA's Rare Disease Plans To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Dealmaking by a pair of pharmas has given the biotech industry its best day of transactions in months, tallying nearly $13 billion in guaranteed payments across two deals. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the takeout of Blueprint Medicines for $9.1 billion up front gives Sanofi a drug for a rare immunological disorder and bolsters the French pharma’s already strong presence in immunology. The analysts also assess the $3.5 billion partnership between BioNTech and Bristol Myers Squibb for an asset targeting cancer’s hottest target, PD-(L)1 x VEGF, and underwhelming data from the leading asset against the target, PD-1 x VEGF bispecific ivonescimab, from Summit and Akeso Inc. Those data coincided with the kick-off of the American Society of Clinical Oncology (ASCO) meeting in Chicago, where almost a dozen companies were presenting readouts for another hot target, CLDN18.2. Evopoint is among the companies; its program recently attracted Astellas as a partner. Meanwhile, the biopharma industry is racing to counter the White House’s most favored nation drug pricing strategy. BioCentury’s Washington analyst, Steve Usdin, explains the urgency and details some of industry’s options. View full story: https://www.biocentury.com/article/656097 #biotech #biopharma #pharma #lifescience #deals 00:00 - Introduction 04:39 - Sanofi Buys Blueprint 09:22 - BMS-BioNTech 20:01 - Hot Targets 23:40 - Drug Pricing To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Dutch biotech Merus’ EGFR x LGR5 bispecific antibody has caught investors’ attention in the run-up to ASCO as a new approach to block EGFR signaling. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Phase II data from Merus for petosemtamab as they preview the American Society of Clinical Oncology’s upcoming annual meeting. The analysts also assess a setback in a gene therapy trial for Rocket Pharmaceuticals, renewed interest in cancer target EpCAM, and a flurry of biopharma activity on the Hong Kong stock exchange. Finally, the team previews BioCentury’s second annual Grand Rounds R&D meeting, which takes place next week in Chicago. This episode was sponsored by Jeito Capital. View full story: https://www.biocentury.com/article/656038 #biotech #biopharma #pharma #lifescience #RandD #DrugDevelopment 00:01 - Sponsor Message: Jeito Capital 24:52 - HK IPOs 07:12 - ASCO 16:37 - EpCAM 20:16 - Rocket To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Political and market turmoil has raised questions whether the U.S. can retain its biopharma leadership position, and in turn presents Europe with an opportunity to attract talent back to the continent with an offer of a more stable biomedical funding and regulatory environment. Jeito Capital’s Ksenija Pavletic and Cambridge Innovation Capital’s Anne Horgan join BioCentury’s analyst to wrap up the 25th annual Bio€quity Europe conference in Bruges, Belgium, by discussing their key takeaways from the two-day event. This episode was sponsored by Jeito Capital. View full story: https://www.biocentury.com/article/655998 #biotech #biopharma #pharma #lifescience #networking 00:01 - Sponsor Message: Jeito Capital 02:10 - Key Takeaways 09:13 - Challenges and Opportunities for Europe 19:23 - Capital Efficiency and Success Stories 28:27 - Leadership, Teams & Talent To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The turbulence that has come with the Trump administration’s policies related to the U.S. biopharmaceutical industry is creating an opening for Europe to bolster its life sciences industry. On the latest BioCentury This Week podcast, BioCentury’s editors look at how Europe can capitalize on staffing cuts at FDA and NIH and an uncertain policy environment to lure back talent to bolster regulatory agencies and biotech R&D engines and attract assets and partners from China. The editors also discuss two biotech deals driven by former leaders of BD at Roche, Biomarin's James Sabry and Sophie Kornowski at Boston Pharmaceuticals. Under the leadership of Sabry and CEO Alexander Hardy, Biomarin delivered its first takeout in a decade by acquiring Inozyme as it positions itself to take advantage of a regulatory and policy environment that they believe is favorable to their rare disease strategy. CEO Kornowski, meanwhile, executed on a plan to focus her company on a single liver disease asset that GSK acquired for $1.2 billion up front. Finally, BioCentury’s editors discuss the management shake-up at obesity company Novo Nordisk, where Lars Fruergaard Jørgensen, the leader who spearheaded Novo Nordisk’s transformation into a dominant player in obesity, is stepping down. Chan Zuckerberg Chicago Biohub is hosting an exclusive, invite-only reception on June 3 — the eve of BioCentury's Grand Rounds conference — gathering top voices in biotech innovation and investment to exchange bold ideas, spark new collaborations and channel the energy of Chicago’s thriving innovation ecosystem. If you’re interested in attending, please register here. This episode was sponsored by Jeito Capital. View full story: https://www.biocentury.com/article/655964 #biotech #biopharma #pharma #lifescience #politics #policy #law 00:01 - Sponsor Message: Jeito Capital 05:05 - European Biotech's Moment? 19:00 - Boston Pharma, Biomarin Deals 29:41 - Novo Nordisk CEO To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Biopharmas developing therapies for obesity are looking to a future where the quality of weight loss matters as much as the quantity — what targets and programs could help realize that vision? On the latest BioCentury This Week podcast, BioCentury’s editors discuss the signaling pathways that may exclusively target fat mass while preserving, or even increasing, lean mass — and which companies are playing in the space. The editors also assess what Vinay Prasad’s past comments say about how he might lead FDA’s Center for Biologics Evaluation and Research (CBER) — and examine how investors are evaluating the possibility that he might move the bar for regulatory approvals. The team then introduces the first in a new BioCentury series, with a look at a Literature Dive into ovarian cancer “atlases” — large-scale molecular profiling studies that point to predictive signatures and patient stratification strategies. This episode was sponsored by Jeito Capital. View full story: https://www.biocentury.com/article/655898 #biotech #biopharma #pharma #obesity #FDA #CBER #LifeScience #OvarianCancer 00:01 - Sponsor Message: Jeito Capital 03:22 - Obesity: Quality over Quantity 15:47 - Prasad at FDA 27:58 - Ovarian Cancer Atlases To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

This year’s Bio€quity Europe conference — the 25th edition of the event — will focus on what’s next for Europe amid biotech’s current complex moment, Editor in Chief Simone Fishburn said on a special edition of the BioCentury This Week podcast previewing the meeting, which kicks off May 12 in Bruges, Belgium. McKinsey & Co.’s Alexandra Zemp and Henk Joos, an investment specialist at Medvia, which fosters health innovation in Flanders, joined BioCentury to discuss the state of Belgium’s biopharma ecosystem and preview some of the conference’s networking events, fireside chats and panel discussions. Claire Macht, portfolio director, Europe, of BioCentury’s conference partner EBD Group, also joined the podcast to detail what to expect in terms of one-on-one partnering meetings at the event. Bio€quity Europe 2025 is sold out, but space on the waitlist remains, and digital passes are available. See the conference website for more information. View full story: https://www.biocentury.com/article/655883 #biotech #biopharma #pharma #networking #LifeScience 00:00 - Introduction 01:25 - What's Next for Europe? 06:58 - Belgium's Biotech Ecosystem 10:29 - McKinsey on European Biotech 15:27 - Partnering, Panels of Note To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Among the formerly undruggable targets gaining translational momentum, SMARCA2 has intrigued researchers for its potential to treat challenging solid tumors. On the latest BioCentury This Week podcast, BioCentury's editors zero in on preclinical research supporting different degraders of SMARCA2 at this year’s American Association for Cancer Research (AACR) annual meeting. They also discuss takeaways from Editor in Chief Simone Fishburn’s conversation with David Baker, the Nobel-prizewinning pioneer in protein design, and Steve Usdin reports that pharmaceutical industry executives are in a state of alarm over President Trump’s push to include a “most favored nation” policy for Medicaid drug purchases in budget reconciliation legislation. Usdin also discusses why industry executives are confident of a fix for the Inflation Reduction Act’s “pill penalty” and FDA Commissioner Marty Makary’s decision to reject proposals to reorganize the agency. This episode was sponsored by Jeito Capital. View full story: https://www.biocentury.com/article/655851 #biotech #biopharma #pharma #LifeScience #RandD #DrugDevelopment #AACR #SMARCA2 00:01 - Sponsor Message: Jeito Capital 03:01 - AACR Spotlight 11:21 - David Baker Protein Design 19:12 - Trump's Drug Pricing Plan To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Belief in tau — both as a target and surrogate endpoint — for Alzheimer’s is building among leaders in the field. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses how tau could be reaching a tipping point. Also on this week’s episode, Washington Editor Steve Usdin details how political moves have begun to intrude into the Trump administration’s regulation of vaccines, a topic that’s also taken up by Phil Krause and Luciana Borio in a BioCentury Guest Commentary published Monday. BioCentury’s editors then discuss delays for drug regulation at FDA, Merck KGaA's $3.9 billion deal to acquire Springworks, and why biotech IPOs could soon have a moment in Hong Kong. This episode of BioCentury This Week podcast is sponsored by RemeGen. View full story: https://www.biocentury.com/article/655780 #biotech #biopharma #pharma #lifescience #alzheimers #RandD #DrugDevelopment #IPO 00:01 - Sponsor Message: RemeGen Co. 02:06 - Tau Time for Alzheimer's 13:10 - Vaccine Drama at FDA 23:32 - Merck KGaA's SpringWorks Buy 24:52 - Hong Kong Biotech IPOs To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Biopharma companies are vying to dethrone Vyvgart as a leading therapy for myasthenia gravis, with the latest data for therapies treating the rare autoimmune neuromuscular disease coming at this month’s American Academy of Neurology. On a special episode of the BioCentury This Week podcast, BioCentury’s editors discuss the landscape for MG therapies, including anti-BLyS and APRIL therapy telitacicept from Remegen. Joining BioCentury’s editors are Qing Zuraw, chief development officer of podcast sponsor RemeGen, and Amit Sachdev, PI on global trials of the biotech’s therapy. BioCentury’s editors also preview the American Association for Cancer Research annual meeting, where degraders and bispecifics are defining translational trends at this year’s event. This episode of BioCentury This Week podcast was sponsored by RemeGen. View full story: https://www.biocentury.com/article/655751 #biotech #biopharma #pharma #lifescience #AAN #AACR 00:01 - Sponsor Message: RemeGen Co. 01:02 - Myasthenia Gravis at AAN 08:31 - RemeGen's Telitacicept 18:03 - AACR: Targets and Trends To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The academia-industry interface is more important than ever for sustaining biomedical innovation’s forward momentum, even as the Trump administration injects turbulence into academic funding for universities. On a special edition of the BioCentury This Week podcast, BioCentury’s Simone Fishburn and Karen Tkach Tuzman preview Grand Rounds, BioCentury’s second annual R&D conference, along with special guests. Spots are filling up for the Grand Rounds U.S. Presenting Company Class of 2025. Find out how to apply here. View full story: https://www.biocentury.com/article/655696 #biotech #biopharma #pharma #lifescience #academia #chicago #asco 00:00 - Introduction 01:42 - Key Themes and Featured Sessions 07:37 - Chicago's Role in Biotech Innovation 15:06 - McKinsey's Insights 25:18 - Upcoming Events and Networking Opportunities To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The biotech community is reeling, fearful and furious about the fallout of tariff, FDA and NIH policies, according to BioCentury’s newly released Risk Sentiment survey. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from the survey, which polled 328 biopharma stakeholders during April 10-14. The editors dissect the latest from Washington, including comments from FDA Commissioner Marty Makary on a new pathway for ultrarare drugs and his plans to reform advisory committee meetings, as well as last week’s executive order on drug pricing. They also discuss how China’s biotechs may have cracked one of the key bottlenecks for both speeding up and de-risking early drug development — and what this means for U.S. biotech. This episode of BioCentury This Week podcast was sponsored by RemeGen. View full story: https://www.biocentury.com/article/655690 #biotech #biopharma #pharma #lifescience #FDA #politics #policy #law 00:01 - Sponsor Message: RemeGen Co. 02:00 - Sentiment Survey 20:18 - Makary's FDA Plans 29:51 - China Speed To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

FDA’s plan to move away from animal toxicity testing could expedite INDs and cut costs for biopharma companies, while helping the U.S. maintain its position as a clinical research hub. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the agency’s new three-year road map to reduce animal safety studies for mAbs. The editors then discuss the deepening morale crisis at FDA after HHS Secretary Robert F. Kennedy Jr. accused the agency of corruption, encouraged staff to report supervisors over approval decisions they oppose, and endorsed conspiracy theories about the “deep state.” They assess the impact of whipsawing tariff policies and turmoil at FDA on biotech indexes — and why the sky isn’t falling just yet for biotech’s specialist investors. The editors also highlight recent stories on base editors’ efficiency boom and how exosomes are finding new life. This episode of BioCentury This Week podcast was sponsored by RemeGen. View full story: https://www.biocentury.com/article/655622 00:01 - Sponsor Message: RemeGen Co. 02:38 - Replacing Animal Models 09:40 - RFK Jr. & FDA 19:36 - NIH 30:02 - BioPharma Market Pulse 33:23 - Innovation Highlights To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Loss of leadership, cuts to staffing and a proposed reorganization at FDA have heightened biotech risk amid an already turbulent macroeconomic climate, according to BioCentury’s Washington editor Steve Usdin. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the turmoil at FDA could affect a sector already grappling with the uncertainty brought by the Trump administration’s trade war. The editors also explore the growing pipeline of VEGF-targeted bispecifics in a preview of upcoming presentations at annual meeting for the American Association for Cancer Research (AACR). And they discuss how companies may once again need to lean on their bear market survival toolkit, as part of BioCentury’s 2Q25 Financial Markets Preview. This episode of BioCentury This Week was sponsored by RemeGen Co. View full story: https://www.biocentury.com/article/655566 00:01 - Sponsor Message: RemeGen Co.  01:19 - FDA and Tariffs Turmoil 16:54 - AACR Preview 20:44 - Bear Market Toolkit To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Biotech indexes are tumbling after one of FDA’s last veteran leaders was pushed out by HHS Secretary RFK Jr. and the threat of tariffs weigh on a key biotech index. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the factors driving down the XBI, which has now crossed into bear market territory and the latest turmoil at FDA, now that CBER Director Peter Marks has been ousted. Plus, inflammation and immunology companies are finding ways beyond precision medicine to boost responses. BioCentury’s editors assess one approach — bispecific antibodies that block two inflammatory pathways instead of one. View full story: https://www.biocentury.com/article/655488 00:00 - Introduction 00:51 - XBI's Return to the Bear Market 11:26 - Marks Ouster & Turmoil at FDA 18:07 - Bispecifics for I&I To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

European venture firm Sofinnova Partners is expanding the reach of its Biovelocita accelerator beyond Italy to stretch across the greater continent. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how Biovelocita became the largest life sciences accelerator in Europe. The editors also discuss Novo Nordisk's latest addition to its obesity pipeline via a deal in China, and how the partnership reflects the state of cross-border dealmaking more broadly. And Washington Editor Steve Usdin assesses President Trump’s threat to impose 25% tariffs on pharmaceutical imports and provides an update on how FDA’s staff is navigating the policies of the new administration. Finally, Editor in Chief Simone Fishburn discusses BioCentury's upcoming Grand Rounds meetings. View full story: https://www.biocentury.com/article/655438 00:00 - Introduction 02:25 - Sofinnova’s Pan-European Accelerator 08:27 - China Biotechs 14:59 - Trump Tariffs To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

BIO is engaging with President Donald Trump to protect and improve FDA. It’s also hoping biopharmas can dodge tariffs and find paths to modify the Inflation Reduction Act and reinstate pediatric priority review vouchers. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin delivers takeaways from his conversation with John Crowley, CEO of the industry trade group. BioCentury’s editors also discuss how autoimmune CAR T companies are competing for resources and the end-to-end radiopharma ambitions of Telix Pharmaceuticals. A 2023 landscape on the radiopharma space can be found here. View full story: https://www.biocentury.com/article/655370 00:00 - Introduction 02:09 - BIO's Trump 2.0 Plan 14:00 - Autoimmune CAR Ts 21:05 - Telix's Radiopharma Play To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

While the culling of companies in the biotech bear market may have yet to subside, creative cross-border deal-making on innovative assets is spreading across Asia’s Arc of Innovation. Sciwind Biosciences Co. Ltd.’s Jing Shu and A*Star’s Lisa Ooi join BioCentury to wrap up the 4th annual BioCentury-BayHelix East-West Biopharma Summit in Singapore by discussing deal-making trends, the rise of new technologies and the deepening of biotech ecosystems from India to Japan. View full story: https://www.biocentury.com/article/655318 00:00 - Introduction 01:58 - Key Takeaways 08:42 - Innovation in Japan and India 12:54 - Building Biotech Ecosystems 31:14 - NewCo Model To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The almost certain confirmation of Marty Makary as FDA commissioner this month will cap a transition marked by internal upheaval and political infighting. On the latest BioCentury This Week podcast, BioCentury’s editors discuss Thursday’s confirmation hearing for President Donald Trump’s pick to lead the agency and Makary's hints at what we can expect from his agenda. The editors also discuss whether the advantages of amylin agonists could help the therapies outshine GLP-1 in obesity, why the latest weight loss data from CagriSema weighed on shares of Novo Nordisk, and a call to deliver on the meritocracy ideal, now that DEI is dead. View full story: https://www.biocentury.com/article/655302 00:00 - Introduction 01:10 - Makary’s FDA Agenda 10:50 - Amylin in Obesity 24:21 - Life After DEI To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The track record of biotechs launched to create curative therapies using CRISPR-Cas9 provides new insights into the old debate over whether platform companies should validate their technology on established targets or pursue new ones. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the lessons learned by this small group of companies since their launch a decade ago. They also discuss the entrance of AbbVie into the obesity race via a $350 million deal with Gubra for a clinical stage amylin agonist — does it signal AbbVie’s belief in amylin monotherapy, or will the company be hunting for more obesity assets? The editors also talk about recommendations to streamline the early-stage development of rare disease therapies in the U.S. View full story: https://www.biocentury.com/article/655214 00:00 - Introduction 00:36 - CRISPR Companies 09:22 - AbbVie Enters Obesity Race 17:19 - Rare Disease Drug Challenges To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Once pharma’s oncology powerhouse, Roche is charting a new course that extends beyond its traditional stronghold in cancer therapeutics. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the Swiss pharma has reshaped its strategy for long-term growth. They also discuss another tumultuous weekend for staff at FDA and NIH, as well as the challenges of precision medicine for psychiatric conditions. View full story: https://www.biocentury.com/article/655157 00:00 - Introduction 00:45 - Roche Reboot 08:47 - Precision Medicine in Psychiatry 13:07 - 5 Things on Trump 2.0 To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Rather than fretting over increasing competition from Chinese life sciences companies, biotechs in the U.S. should rise to the challenge and learn from their competitors. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the increasing pace of innovation from China and how U.S. biotechs need to meet the moment, delivering key takeaways from Editor in Chief Simone Fishburn’s fireside chat with industry leader John Maraganore at the BIO CEO & Investor Forum in New York last week. The team also discusses the fallout from staffing cuts at FDA — severely damaged morale among remaining staff and the potential for a higher approval bar, among others — leadership at the agency and the state of biotech IPOs on NASDAQ and in Korea. View full story: https://www.biocentury.com/article/655112 00:00 - Introduction 00:58 - Competing with China 14:13 - FDA, NIH Staff Cuts 20:16 - Biotech IPOs  To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Western VCs are paying more attention than ever to innovation emerging from Asia — from antibody-drug conjugates to bispecifics, AI and beyond — as the NewCo Model becomes the latest trend to bridge talent, assets and venture money across the Pacific and on to North America and Europe. On a special edition of BioCentury This Week podcast, a trio of leaders from Asia’s life sciences ecosystem — Khoo Shih of Singaporean investor ClavystBio, McKinsey & Company’s Anirudh Roy Popli and Wendy Pan of Goodwin and BayHelix — join the BioCentury team to set the stage for the fourth BioCentury-BayHelix East-West Biopharma Summit. They discuss the innovations driving the deal flow from East to West, including the creation of start-ups in the West formed around assets from Asia. The summit takes place March 3-5 in Singapore. View full story: https://www.biocentury.com/article/655108 00:00 - Introduction 04:49 - The Newco Model and Industry Trends 09:13 - BayHelix and Cross-Border Transactions 11:31 - McKinsey's Perspective on Asian Innovation 26:58 - Final Thoughts and Registration Information To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

White House plans to slash FDA and NIH risk decimating two agencies at the core of U.S. biomedical innovation. On the latest BioCentury This Week podcast, BioCentury’s editors assess draft plans by the Trump administration that seek to halve FDA staff, cut NIH, and reduce overhead payments to academic institutions. The policy addressed in a recent Guest Commentary for BioCentury, “Defending the NIH, the NSF and the foundation of American science,” by the Scleroderma Research Foundation’s Luke Evnin, Peter Rubin of No Patient Left Behind, and Ra Capital’s Peter Kolchinsky. BioCentury’s team also discusses how biotechs are becoming increasingly successful at navigating the obstacles to get precision therapies across the FDA finish line. View full story: https://www.biocentury.com/article/655034 00:00 - Introduction 00:59 - FDA, NIH & Trump 2.0 16:26 - Biotechs & Precision Medicine To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The boom in the creation of companies that were launched in the West based on assets sourced in Asia signals China’s galloping speed of innovation. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the “NewCo Model,” who the players are, from CEOs and companies to investors; the areas of innovation the start-ups are tackling; and the evolution of the trend. (Read about the company that kicked off the trend, Arrivent, here.) The editors also assess how personnel losses at FDA from the Trump administration’s plans to slash government payrolls are likely to cause short- and long-term harm for the agency and the drug approval process. And a new pain therapy from Vertex is in the spotlight as the CF specialist enters new turf. View full story: https://www.biocentury.com/article/654946 00:00 - Introduction 01:20 - Asia's NewCo Model 16:22 - FDA Tipping Point 20:27 - Vertex's Pain Drug To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Psychiatric drug development has had major wins over the past year-and-a-half — think Karuna Pharmaceuticals' $14 billion takeout by Bristol Myers Squibb and the subsequent launch of a new schizophrenia therapy — but targeted neuropsychiatric drug development is still in its infancy. On a special edition of the BioCentury This Week podcast, BioCentury’s editors detail the promise of precision medicine in the space and break down what recent setbacks for key players mean for next steps in the clinic. The team is joined by special guest Peter Schueler, SVP of drug development solutions, neurosciences, at ICON, who delivers takeaways from this month’s the ECNP Roadmap Meeting on Precision Psychiatry in Frankfurt and a recent white paper by ICON. This episode of BioCentury This Week was sponsored by ICON Biotech. View full story: https://www.biocentury.com/article/654903 00:01 - Sponsor Message: ICON Biotech 02:20 - Precision Neuropsychiatry 06:39 - Insights from ICON's Peter Schueler 15:59 - Challenges in Neuropsych To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

BioCentury’s analysis of the technologies behind last year’s biotech series A raisers sees progress in nanoparticles, CAR cell therapies, degraders and antibody-drug conjugates. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the trends spotted in 2024’s crop of more than 150 series A rounds — from top therapeutic areas and modalities to the leading investors funding the innovation. The editors turn to Washington for takeaways from BioCentury’s “exit interview” with Patrizia Cavazzoni, the recently departed director of FDA’s Center for Drug Evaluation and Research, and checks in on FDA and NIH’s turbulent transition under Trump 2.0. Finally, the podcast team previews BioCentury’s upcoming fourth East-West Summit, which will focus on globalizing Asia innovation and the red-hot “Newco Model” in Singapore March 3-5, and the twenty-fifth Bio€quity Europe, which will be held in Belgium in May. This episode of BioCentury This Week was sponsored by ICON Biotech. View full story: https://www.biocentury.com/article/654837 00:01 - Sponsor Message: ICON Biotech 01:57 - Series As: Trends in Innovation 12:18 - BioCentury Conferences Preview 18:45 - Insights from FDA's Cavazzoni 21:58 - Turbulence at FDA, NIH To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

With political uncertainty overshadowing market sentiment going into 2025, BioCentury’s editorial team assesses the bull and bear arguments for biotech in the New Year on the BioCentury This Week podcast’s Public Markets Preview. Will continued uncertainty drive biotech sentiment in the coming months, or will the bear arguments fail to manifest, stymied by M&A and other positive factors? In the second part of the 2025 Preview, BioCentury’s editors highlight some of the key catalysts in bispecifics, immunology and inflammatory (I&I), new modalities, and neurology and obesity they are watching in the year ahead. Finally, the editors discuss how VC firms focused on AI-driven drug development are thinking about the resources and strategies needed to turn promise into reality. This episode of BioCentury This Week was sponsored by ICON Biotech. View full story: https://www.biocentury.com/article/654772 00:01 - Sponsor Message: ICON Biotech 02:33 - Market Uncertainty 12:50 - Biotech Catalysts 21:12 - Obesity 22:57 - Neurology 28:54 - AI: VC Perspectives To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Sunshine and a stream of deals brightened the mood at this year’s J.P. Morgan Healthcare Conference, offering a pleasant counterpoint to continued pessimism over the state of the capital markets. On the latest BioCentury This Week podcast, BioCentury’s editors deliver their takeaways from biotech’s annual kick-off event from megarounds and Asian newcos to the new state of M&A and pending change at FDA. View full story: https://www.biocentury.com/article/654723 00:00 - Introduction 01:52 - Market Sentiments and Deal Expectations 04:42 - Cross-Border Deals and Asia's Growing Influence 07:12 - Neurology and Innovation in Biotech 14:44 - VC Trends and Megarounds 20:00 - Upcoming East West Singapore To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

J&J’s $14.6 billion takeout of neurology play Intra-cellular Therapies headlined a buzzy start to the J.P. Morgan Healthcare Conference, where a flurry of deal announcements recalled the conference’s pre-pandemic days. On the latest BioCentury This Week podcast, BioCentury's editors discuss the takeout of Intra-cellular, the third 11-digit neuro M&A in the past 13 months, as well as M&A involving Idrx and GSK, and Scorpion Therapeutics and Eli Lilly. Turning to Washington, the team explores what’s behind BIO CEO John Crowley’s visit to Mar-a-Lago to meet with President-elect Donald Trump, impending changes at FDA under Trump 2.0 and key takeaways from Rep. Jake Auchincloss appearance on BCTW’s sister podcast, The BioCentury Show. The team also breaks down the key trends in the past year in FDA approvals. This episode of BioCentury This Week was sponsored by ICON Biotech. View full story: https://www.biocentury.com/article/654694 00:01 - Sponsor Message: ICON Biotech 02:38 - JPM Deal Buzz 11:20 - Washington Update 16:08 - Rep. Auchincloss’ Take on Biopharma 21:01 - FDA Regulatory Decisions To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Can biotech break free of the macro factors that have buffeted the industry of late? On the first BioCentury This Week podcast of 2025, BioCentury’s editors offer their predictions for the New Year and — exploring the themes from Simone Fishburn’s latest Letter from the Editor — ask whether biotech can overcome the financing environment, policy concerns and geopolitical tension that have been hammering the industry to deliver on the meaningful strides companies have been taking to deliver innovations to patients. Plus, Washington Editor Steve Usdin discusses what U.S. policymakers need to do now in the wake of a year’s worth of wrangling over the Biosecure Act, and Executive Editor Selina Koch breaks down readouts from Neumora on its KOR antagonist navacaprant to treat major depressive disorder and Axsome Therapeutics for its AXS-05 to treat agitation in Alzheimer’s patients. This episode of BioCentury This Week was sponsored by ICON Biotech. View full story: https://www.biocentury.com/article/654620 00:01 - Sponsor Message: ICON Biotech 01:51 - Biotech's Repeating Challenges 10:52 - Biotech in the New Year 23:07 - Beyond Biosecure 28:10 - Neurology Readouts To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Preview: In his five decades at FDA, Robert “Bob” Temple helped revolutionize the ways medical products are developed and regulated. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin reflects on the legacy of Temple. Temple, who is retiring, crafted the modern clinical trial paradigm, created the accelerated approval pathway, and set precedents for incorporating patient perspectives in regulatory decisions. Usdin also discusses the opportunities and threats for the agency under Trump 2.0.BioCentury's editors also discuss China’s academic innovation, arguing that a wave of new target biology is now coming from Chinese university labs and the underwhelming results from CagriSema’s latest readout. Phase III data for the most important weight loss candidate from  Novo Nordisk A/S (CSE:NOVO-B; NYSE:NVO) failed to differentiate the product from Eli Lilly's Zepbound. View full story:https://www.biocentury.com/article/654574/temple-s-fda-legacy-plus-chinese-innovation-novo-obesity-data-a-biocentury-podcast 00:00 - Introduction 02:03 - Bob Temple's Legacy 16:13 - China's Academic Innovation 26:20 - CagriSema Obesity Data To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

With most of the highly attractive late-stage assets already scooped up, pharmas are turning their sights to Phase II companies, and lining up their case to make an attractive offer and move fast. About 40% of the M&A deals in 2023-24 were completed in less than six weeks, from approach to announcement, according to Lazard’s data. Michael Kingston and Dale Raine, global co-heads of biopharma at Lazard, joined The BioCentury Show this week to discuss the M&A outlook amid the still-precarious biotech financing landscape. The BioCentury Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel. View full story: https://www.biocentury.com/article/653858 00:00 - Introduction 03:01 - Capital Markets Outlook 06:01 - M&A 15:19 - Breaking Down Deals 24:29 - Asia To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Lately, it appears some biotech VCs have hit a ceiling, capping their new funds at or below the amount of their previous vehicles, says Paul Bonanos on the latest BioCentury This Week. Bonanos and his BioCentury editorial colleagues discuss what’s behind the trend as they assess VC fundraising in this post-‘supercycle’ era. The editors also evaluate the state of play for venture-backed obesity plays and which VCs are active in the space, as well as takeaways from the latest BioCentury Show podcast featuring Aoife Brennan, CEO of Climb Bio. Finally, the team features the new book from long-time biotech executive and current SV Health Investors partner Tim Harris, In Pursuit of Unicorns: A Journey through 50 Years of Biotechnology. View full story: https://www.biocentury.com/article/654488 00:00 - Introduction 02:08 - Trends in VC Funds 12:16 - Obesity Start-ups 19:46 - The BioCentury Show with Aoife Brennan 26:50 - Tim Harris' New Book: In Pursuit of Unicorns To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

A pair of lawmakers have dealt the Biosecure Act a setback that could derail the legislation, even as Congress continues its push to reduce reliance on China in the life sciences. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains why Sen. Rand Paul (R-Ky.) and Rep. Jamie Raskin (D-Md.) refused to sign off on inclusion of the anti-China biotech bill in the must-pass National Defense Authorization Act, what provisions the defense bill has that seek to enhance U.S. biotech supply chain resilience and whether Biosecure can be resurrected. And in the latest in neurology, Executive Editor Selina Koch discusses Novartis and PTC's $1 billion deal for the biotech’s Huntington disease therapy, and how several biotechs are poised to take therapies against the long undruggable KCC2 to the clinic for neurological disorders. Heads up: BioCentury’s JPM Guide 2025 is out now. View full story: https://www.biocentury.com/article/654420 00:00 - Introduction 01:42 - Biosecure Setback 10:01 - Novartis' $1B PTC Deal  16:28 - KCC2 Activation To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

On the latest BioCentury This Week podcast, Washington Editor Steve Usdin and colleagues discuss how President-elect Donald Trump’s pick to lead NIH, Jay Bhattacharya, would lead NIH and how that could affect the biopharma industry. The BioCentury team then discusses its analysis of abstracts released ahead of the American Society of Hematology (ASH) and Society for Immunotherapy of Cancer (SITC) annual conferences, highlighting methods for applying dual or bispecific CAR T cell designs to solid tumors. And they also analyze FDA approvals of products by biotech companies, noting that current trends show biotechs shedding their reliance on pharma to get drugs across the finish line for approval. View full story: https://www.biocentury.com/article/654363 00:00 - Introduction 01:08 - Trump's NIH Pick 12:13 - Multi-targeted CAR Ts 19:26 - Biotech FDA Approvals To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Positive vibes about biotech emanating from the Jefferies Healthcare Conference were overshadowed by the uncertainty that is ahead because of the result of the U.S. elections. On the latest BioCentury This Week, BioCentury’s editors discuss how the unconventional cabinet nominations of the incoming Trump administration have cast a pall over what had been growing enthusiasm for the prospects of the biotech sector. Washington Editor Steve Usdin also discusses what the nomination of Marty Makary as the next FDA Commissioner could mean for the sector, and recaps the latest update on the Biosecure Act. The BioCentury editors also discuss which pharmas are in or out in making a challenge to Eli Lilly and Novo Nordisk in the obesity market. View full story: https://www.biocentury.com/article/654319 00:00 - Introduction 00:32 - Jefferies Conference Takeaways 06:25 - Trump Nominations 17:41 - Biosecure Act Update 21:01 - Pharma in Obesity To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Giving RFK Jr. control of HHS would be disastrous, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Expanding on his Editor’s Commentary, Usdin explains why Kennedy would be an unmitigated disaster for FDA, NIH and CMS, for biopharmas and for patients. He calls on biopharma leaders to speak out and affirm basic truths, even if it puts them in harm’s way. BioCentury’s editors also discuss why new data for GSK's Blenrep — an oncology therapy withdrawn two years ago — help make the case for introducing new therapies earlier in the course of treatment, and the recent bolus of West-East deals, including two around anti-PD-(L)1 x VEGF bispecifics: BioNTech's acquisition of Biotheus, and Merck's licensing of global rights to a LaNova asset. View full story: https://www.biocentury.com/article/654233 00:00 - Introduction 01:12 - RFK Jr. & HHS 13:15 - Blenrep's Comback 19:25 - China Deals To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Trump 2.0 presents opportunities and challenges for leaders of the biopharma industry, which needs effective public policy to thrive. On the latest BioCentury This Week, BioCentury Washington Editor Steve Usdin explains what those opportunities are and lays out the potential impact on the public policy environment, which could have repercussions on FDA and beyond. BioCentury’s editors then analyze how companies, academics and advocates are pushing back on claims that they should have disclosed the results of APOE4 genotype testing to Alzheimer’s trial participants and investigations by Chinese authorities into AstraZeneca China President Leon Wang and fellow AZ employees past and current, assessing what’s known about the allegations and whether the situation could affect other MNCs operating in the country. View full story: https://www.biocentury.com/article/654157 00:00 - Introduction 01:01 - Prepping for Trump 09:41 - Alzheimer's Ethics 17:44 - AstraZeneca's Challenges in China 21:51 - Myths and Misperceptions To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

It’s too soon to conclude anti-amyloid therapies are safe for use by Alzheimer’s patients in the real world, even as early reports are encouraging, argues BioCentury Executive Editor Selina Koch on the latest BioCentury This Week podcast. Koch and colleagues discuss takeaways from this year’s Clinical Trials on Alzheimer’s Disease annual meeting, including conclusions from adverse event data for Leqembi lecanemab and what the true test of appropriate use and safety for the drug might look like. BioCentury’s editors also assess Phase II data presented at CTAD by UCB that provide some of the first clues about what species of tau to target and in which patients. And they discuss what results of Tuesday’s presidential contest in the U.S. will mean for FDA, as well as the state of play for China biotech as the industry continues to grind out its first bear market. View full story: https://www.biocentury.com/article/654075 00:00 - Introduction 01:23 - CTAD: Anti-amyloids 14:22 - CTAD: UCB's tau data 19:47 - FDA & the Election 28:16 - China Summit Debrief To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Twenty years of innovation in therapies targeting EGFR provides a case study in how generation of differentiated products against the target can drive market growth. On the latest BioCentury This Week podcast, BioCentury’s editors discuss EGFR as a prime example of the value in best-in-class development strategies, with meaningful improvements across multiple modalities delivering substantial therapeutic benefits to patients. Analogous best-in-class opportunities aren’t limited to cancer, but are also playing out in other settings such as immunology. The editors then discuss a recent event that hosted FDA commissioner Rob Califf and four former commissioners, all of whom agreed a major role of the FDA commissioner is to protect the agency from political interference. Washington Editor Steve Usdin also previews his conversation with FDA’s Richard Pazdur, and Editor in Chief Simone Fishburn details takeaways from her Q&A with James Sabry, who recently became CBO at BioMarin Pharmaceutical. View full story: https://www.biocentury.com/article/653926 00:00 - Introduction 00:38 - EGFR Case Study 08:45 - FDA Commissioners & Politics 19:19 - James Sabry's Timeline To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Cross-border geopolitical tensions and a prolonged capital crunch are compelling biopharma companies from Beijing to Boston to rethink their strategies on everything from deal-making and raising capital to manufacturing and use of CROs. On a special edition of the BioCentury This Week podcast, McKinsey’s Franck Le Deu and Wendy Pan of BayHelix and Goodwin join BioCentury on the eve of next week’s eleventh annual BioCentury-BayHelix China Healthcare Summit in Shanghai to discuss the dynamics affecting biotechs in China looking beyond the country’s borders and Western biopharma companies seeking innovation and partners in China, as well as the latest trends, such as U.S. VCs and/or management teams building newcos around China assets. They also detail highlights among the three-day event’s speakers, panels and fireside chats. The BioCentury-BayHelix China Healthcare Summit will take place Oct. 30 through Nov. 1 at the St. Regis Shanghai Jian in Shanghai. For information on registering to attend and/or becoming a presenting company, click here. View full story: https://www.biocentury.com/article/653959 00:00 - Introduction 03:32 - The View from BayHelix 06:59 - The View from McKinsey 18:57 - Summit Highlights To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

At least 25 venture firms have raised a total of more than $17 billion in funds this year, with Forbion unveiling the largest-ever European biopharma fund at €1.2 billion last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how Forbion deployed its prior fund and quickly raised fresh funds and what that — and other funds — say about the state of financing private biotechs in Europe and elsewhere. The editors then assess takeaways from BioCentury’s conversation with NIH’s Daniel Reich on data that could shape drug development’s future for progressive multiple sclerosis, and neurodegeneration broadly, as well as how the first clinical data from an RNA-editing oligonucleotide therapy from Wave Life Sciences demonstrate that it’s possible to change a single base in an RNA to correct a disease-causing mutation in patients. View full story: https://www.biocentury.com/article/653924 00:00 - Introduction 02:48 - VC Funds 11:50 - New Chapter for MS 23:48 - Wave's Data To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

There is a growing mandate among researchers and VCs to provide proof of causal human biology for new targets. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the different strategies being deployed to identify causal links to disease using observational patient data or human cell models, including the challenges that come with each approach and the various computational methodologies companies are using. They also discuss the outcome of FDA’s advisory committee meeting on Barth syndrome candidate elamipretide from Stealth Biotherapeutics, and the implications of the discussion for review of ultrarare disease therapies more broadly. Diving into the deal of the day, the editors review the proposal by H. Lundbeck to acquire Longboard Pharmaceuticals for $2.6 billion, and discuss how the biotech’s therapy for developmental epilepsies may stack up against competitors. View full story: https://www.biocentury.com/article/653843 00:00 - Introduction 00:34 - Causal Biology and Big Data 17:52 - FDA's Ultra-Rare Decision 27:29 - Lundbeck Acquires Longboard To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Biopharma buysiders and bankers at long last believe the conditions are ripe for biotech growth and outperformance, BioCentury’s Stephen Hansen says on the latest BioCentury This Week podcast. Hansen and colleagues take stock of the sector’s growth potential after three long years of the bear market as they discuss BioCentury’s 4Q24 Public Markets Preview. Also on this week’s show, Washington Editor Steve Usdin discusses his Editor’s Commentary, in which he argues that FDA leaders planned reforms for its advisory committee process fall far short of what they need to do. Usdin then delivers takeaways from the most recent edition of BioCentury This Week’s sister podcast, The BioCentury Show, which features a behind-the-scenes look at CMS’s anti-amyloid mAb decision-making process with Lee Fleisher, the former CMO of the agency. Finally, BioCentury’s Josh Berlin joins the podcast to preview the eleventh annual BioCentury-BayHelix China Healthcare Summit, which runs Oct. 30 to Nov. 1 in Shanghai. The theme of this year’s conference, which features panels of pharma BD&L leaders and blue chip investors as well as a lineup of presenting companies, is reinventing your China strategy. 00:00 - Introduction 02:13 - 4Q Public Markets Preview 16:16 - What's on at the China Summit 28:25 - Fixing FDA's Advisory Panels 34:09 - Recap: The BioCentury Show with Lee Fleisher View full story: https://www.biocentury.com/article/653793 To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Approval of BMS’s first-in-class schizophrenia drug is good news for patients and the company’s thinning pipeline alike, but maximizing Cobenfy’s commercial potential depends on readouts in additional indications. On the latest BioCentury This Week podcast, BioCentury’s editors assess the significance of the new therapy and what the pharma needs to do to make its launch a success. They also discuss the impact of the withdrawal of Pfizer's sickle cell therapy; the work left unfinished on biotech-related legislation in Congress; BioAge's NASDAQ IPO; and the importance of FDA’s Oncologic Drugs Advisory Committee meeting on the use of PD-1 inhibitors in patients with certain tumors expressing low levels of PD-L1. This episode of BioCentury This Week was sponsored by Parexel Biotech. View full story: https://www.biocentury.com/article/653732 00:01 - Sponsor Message: Parexel BioTech 01:41 - BMS Schizophrenia Drug 12:28 - Pfizer Withdrawal's Oxbryta 18:26 - ODAC and PDL1 23:56 - D.C. Update 26:51 - BioAge IPO To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

The ESMO Congress yielded another win for cancer immunotherapy target TIGIT, but the readout resurfaced worries about the mechanism’s past failures to turn positive earlier stage data into Phase III success. On a special edition of the BioCentury This Week podcast, BioCentury’s editors deliver their takeaways from this year’s meeting, including analysis of data for TIGIT blocker belrestotug from iTeos Therapeutics, a colorectal cancer readout featuring J&J's Rybrevant and an antibody-drug conjugate from Genmab. The BioCentury team is joined by Gwyn Bebb, who is global franchise head for oncology at podcast sponsor Parexel. Bebb discusses what’s changed in the oncology landscape in the 10 years since the approval of the first immunotherapies, observations that COVID-19 vaccines might have a role in treating cancer and developments in the radiopharma field. This episode of BioCentury This Week was sponsored by Parexel Biotech. View full story: https://www.biocentury.com/article/653681 00:01 - Sponsor Message: Parexel BioTech 01:55 - iTeos' TIGIT Data 04:56 - Rybrevant Colorectal 07:22 - Gwyn Bebb's Take 21:38 - More ESMO Highlights To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Rep. Frank Pallone’s misunderstanding of how the pediatric priority review voucher program works has been one factor undermining support for an incentive that brings new drugs to kids, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin explains how the voucher process works and why it’s valuable to the country’s youngest patients, as well as to small biotechs and larger biopharma alike. Usdin also discusses the latest twists and turns for the Biosecure Act, and BioCentury’s Stephen Hansen assesses the obesity data from Novo Nordisk that destroyed more than $30 billion in value for the Danish pharma. This episode of BioCentury This Week was sponsored by Parexel Biotech. View full story: https://www.biocentury.com/article/653633 00:01 - Sponsor Message: Parexel Biotech 01:47 - Pediatric PRVs 06:42 - Biosecure Act 12:44 - Novo's Obesity Miss To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

On a special edition of the BioCentury This Week podcast, BioCentury’s editors deliver their takeaways from the debut Grand Rounds conference, which focused on whether biotech can write a more successful playbook for translating from target to product. Weaving together takeaways from the panels, fireside chat and keynote at the conference, the editors assess the tensions between generalizability and fit-for-purpose models, between having control and capturing complexity, and, in human data, between scale and robustness/reliability, particularly for longitudinal readouts. The editors also discuss BioCentury's Q&A with USC Keck School’s Patrick Lyden, who explained how high-quality, reproducible preclinical science can be feasible. View full story: https://www.biocentury.com/article/653631 00:00 - Introduction 02:56 - Generalizability vs. Fit for Purpose 10:03 - Control vs. Complexity 17:57 - Scale vs. Robustness in Human Data 26:25 - Hypothesis-Driven vs. Unbiased Research 28:50 - Grand Rounds 2025 To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

On the latest BioCentury This Week podcast, BioCentury’s editors assess the shifting market for biotech IPOs, including the profiles of the three companies that went public on NASDAQ last week, the aftermarket performance of the year's IPO class, and the prospects for more companies to make their own debut in the coming months. BioCentury’s editors also discuss whether the rush to GLP-1s for obesity will mirror the development of PD-1s for cancer and the impact on biopharma of the recent mainstream expansion of AI. This episode of BioCentury This Week was sponsored by Parexel Biotech. View full story: https://www.biocentury.com/article/653538 00:01 - Sponsor Message: Parexel Biotech 01:30 - IPOs 10:56 - GLP-1 & Obesity 22:18 - AI & Biotech To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected]. Reach us by sending a text

Will bispecifics be the drugs to dethrone cancer’s biggest blockbusters? Akeso is the latest company with a bispecific to impress in a head-to-head study, this one for non-small cell lung cancer. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the latest data from Akeso’s ivonescimab, a VEGFxPD-1 bispecific antibody that went up against Keytruda pembrolizumab in one of its largest indications, first-line non-small cell lung cancer. The editors also discuss data from  Vaxcyte that the infectious disease company parlayed into the year’s largest follow-on financing and a new initiative by FDA veteran Janet Woodcock to bolster quality in biopharmas’ manufacturing. This episode of BioCentury This Week was sponsored by Parexel Biotech. View full story: https://www.biocentury.com/article/653507 00:01 - Sponsor Message: Parexel Biotech 01:39 - Akeso's Bispecific Challenge 08:22 - Vaxcyte Pneumococcal Vaccine 12:32 - Woodcock's Quality Initiative 14:48 - Recap: The BioCentury Show on Biosimilars Reach us by sending a text

In this year’s series of Back to School essays, BioCentury’s editors ask whether the era of human first, causal biology and personalized medicine can reshape drug discovery to solve the weakest link in biotech — translation to the clinic. On a special edition of the BioCentury This Week podcast, the three authors of BioCentury’s 32nd Back to School edition, Editor in Chief Simone Fishburn, Executive Editor Selina Koch, and Executive Director of Biopharma Intelligence Lauren Martz, discuss how industry can solve its biggest bottleneck. The editors zero in on inflammation and immunology, specifically how immunoproteomics upstage genomics in I&I target discovery, and neurology, notably how neuroscience companies are reducing to practice the concept of human-first discovery. Finally, they discuss the thread that runs through it all — precision medicine — and how biomarkers can help validate targets while bringing precision medicine to I&I and neurology. View full story: https://www.biocentury.com/article/653485 00:00 - Introduction 01:32 - Introducing Back to School 10:42 - Validation Tools 14:50 - I&I 21:00 - Neurology 27:19 - Precision Medicine Reach us by sending a text

A vote on the Biosecure Act in the U.S. House of Representatives early next week shines the spotlight back on legislation seeking to rein in Chinese CDMOs and genomics companies, as Congress returns to work. On the latest BioCentury This Week podcast, BioCentury’s editors handicap the legislation’s chances of passage in the House and Senate and assess what’s at stake for the law authorizing rare pediatric disease priority review vouchers. They also discuss the results of BioCentury’s snap poll gauging the biopharma industry’s reaction to the IRA Medicare drug price negotiation program, recalling the latest trends among pharma’s deals with biotechs over the past 12 months. Plus, a preview BioCentury’s annual Back to School package, next week’s new Grand Rounds R&D conference and highlights from this month’s Distillery roundup of translational papers. View full story: https://www.biocentury.com/article/653385 00:00 - Introduction 01:36 - Biosecure on Deck 04:33 - Priority Review Vouchers 08:11 - BioCentury IRA Survey 17:07 - Back to School: Target Discovery 19:49 - Translational Highlights Reach us by sending a text

Shaking up an underwhelming year for fresh biotech paper, a trio of biotechs filed to go public on NASDAQ last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the IPO filings by MBX and Massachusetts companies Zenas and Bicara. Washington Editor Steve Usdin returns to the podcast to provide updates on the Inflation Reduction and Biosecure acts, as well as the life sciences policies of presidential candidates Donald Trump and Kamala Harris. And Director of Biopharma Intelligence Karen Tkach Tuzman zeroes in on the latest trends among pharma’s deals with biotechs over the past 12 months and the latest start-up out of Versant Ventures, Borealis. View full story: https://www.biocentury.com/article/653354 00:00 - Introduction 01:48 - Biotech IPOs 12:48 - Washington Update 20:39 - Versant, Novartis Newco 24:34 - Pharma-Biotech Deal Trends Reach us by sending a text

Grand Rounds is an R&D meeting that represents BioCentury’s latest initiative to create new networks linking academic discoveries with translational skills and the investors who will finance them, BioCentury co-founder, President and CEO David Flores said on a special edition of the BioCentury This Week podcast previewing the new conference. The meeting, on Sept. 9-11 in Nashville, focuses on whether biotech can write a more successful playbook for translating from target to product. The podcast features three special guests who will be at the conference: McKinsey's Guang Yang, Candel Therapeutics' Paul Peter Tak, and Abby Trotter of Life Science Tennessee. There is still time to register for BioCentury Grand Rounds, which will take place Sept. 9-11 in Nashville. Network, partner and debate key bottlenecks in translation. See the conference website for more information. View full story: https://www.biocentury.com/article/653324 00:00 - Introduction 00:13 - Spotlight Grand Rounds 02:03 - Conference Themes 08:40 - Nashville's Biotech Ecosystem 16:58 - Paul Peter Tak on I&I 25:22 - McKinsey Report Preview Reach us by sending a text

The Biden administration has disclosed what Medicare will pay for the first graduates of its drug price negotiation program but biopharma companies, biotech investors and patient advocates are still waiting for the government to reveal how those prices were determined — details that are critical to informing the decisions that will shape the future of medicine. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what last week’s disclosure tells us — and what information is yet to come. They also discuss why psychedelics companies believe they can avoid the hurdles that tripped up Lykos Therapeutics as it sought approval of its MDMA program to treat post-traumatic stress disorder (PTSD), and preview this year’s BioCentury Back to School report, which focuses on whether biotech can write a more successful playbook for translating from target to product. Take part in BioCentury’s Snap Survey on the IRA and Part D pricing. We’ll be publishing the results next week, which means we need your input now! All results will be anonymous. View full story: https://www.biocentury.com/article/653298 00:00 - Intro 01:32 - Medicare Drug Pricing 11:38 - Psychedelic Setback 18:53 - Back to School Preview Reach us by sending a text

Pharmaceutical companies and some investors may have once again become wary of gene therapy, but the modality’s future is bright, according to Jim Wilson. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from BioCentury’s exclusive interview with the AAV trailblazer, including Wilson’s prediction that the benefits of the therapies will extend beyond rare genetic diseases, and the rationale for his new therapeutics company, Gemma Biotherapeutics. BioCentury’s head of corporate alliances & business development, Josh Berlin, then joins the podcast team to detail the challenges and opportunities for biotech in South Korea, and to preview some of the highlights of the upcoming Grand Rounds conference. The event, BioCentury’s first R&D conference, takes place Sept. 9-11 in Nashville, Tenn. and tackles the roadblocks in the translation of science into new medicines. View full story: https://www.biocentury.com/article/653239 00:00 - Intro 01:31 - Wilson’s Vision for Gene Therapy 14:23 - Inside Korea's Biotech 21:45 - BioCentury's Grand Rounds Reach us by sending a text

A substantial part of the biopharma ecosystem involves deals between biotechs and academics, with smaller companies accessing assets to add to their pipelines and technologies to help solve problems. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the interplay of biotech and academia, including how deals between the groups often come outside the hubs of Boston and the Bay Area and what types of indications and technologies are common focus points. They also discuss new data in Alzheimer’s for Leqembi from Eisai and Biogen that provide insight into how to get the most out of anti-amyloid mAbs for the disease, and what’s next for James Wilson now that the gene therapy pioneer is moving on from the University of Pennsylvania. View full story: https://www.biocentury.com/article/653174 00:00 - Intro 04:25 - Biotech-Academia Deals 12:04 - Leqembi's Latest Data 19:20 - What's Next for James Wilson Reach us by sending a text

Europe’s CHMP has again ruled in contrast to FDA for a neurology product, this time on Biogen and Eisai’s Leqembi for Alzheimer’s disease. On the latest BioCentury This Week podcast, BioCentury editors discuss the similarities and differences between Leqembi lecenamab and Aduhelm aducanumab, the first anti-amyloid mAb from Biogen and Eisai and what it means for the next in line from that class, Kisunia donanemab from Eli Lilly. The editors also break down last week’s ODAC meeting, which discussed trials in perioperative cancer for checkpoint inhibitors, and talk about the looming delay in reauthorization of the rare pediatric priority review voucher program. They also assess the implications of the investigation by the House Select Committee on the Chinese Communist Party into clinical trials run in Chinese military hospitals and the Xinjiang Uyghur Autonomous region, a story broken last week by Washington Editor Steve Usdin. View full story: https://www.biocentury.com/article/653010 02:06 - CHMP Leqembi Decision 09:53 - Perioperative Cancer 17:45 - Pediatric Review Vouchers  23:55 - Beyond Biosecure Reach us by sending a text

Alpha emitters are the latest trend in the hot radioligand space, but there’s debate about which isotope offers the best attributes for optimizing safety and efficacy. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the benefits and challenges that come with developing radiopharmaceuticals using lead-212 versus its more well-known counterpart actinium-225. They also discuss Editor-in-Chief Simone Fishburn’s conversation with Susan Galbraith, EVP of Oncology R&D at AstraZeneca, the latest innovations in delivering lipid nanoparticles to specific tissues beyond the liver, and the most recent oral GLP-1 obesity data from Roche. View full story: https://www.biocentury.com/article/653008 00:00 - Intro 05:36 - Radiopharma Alpha Emitters 12:18 - AZ’s Susan Galbraith 21:40 - Lipid Nanoparticles 25:22 - Oral GLP-1 Race Reach us by sending a text

Buysiders are upbeat headed into the back half of the year, but uncertainty over the Federal Reserve’s timing on interest rate cuts is keeping that sentiment in check. On the latest BioCentury This Week podcast, BioCentury’s editors preview the public markets’ second half of 2024, discussing the appetite for biotech IPOs and M&A and what investors are looking for as they read the Fed tea leaves. They also discuss Congress’ FDA budget squeeze, the growing momentum of the Biosecure Act — which seeks to rein in Chinese CDMOs and genomics companies in the U.S. — and the legacy of IR/PR pioneer Lisa Burns, who passed away this month after spending years advising biotech CEOs and investors. View full story: https://www.biocentury.com/article/652968 00:00 - Intro 02:54 - 3Q Markets Preview 12:33 - Policy Update 18:40 - Remembering Lisa Burns Reach us by sending a text

The U.K.’s life sciences ecosystem boasts “palpable energy at the very innovation end of the spectrum in biotech, with a lot of really quality science,” BioCentury Editor in Chief Simone Fishburn says on the latest BioCentury This Week podcast. Fishburn assesses the maturation of the country’s biotech industry, including the need for an influx of capital to catalyze the sector’s growth. Washington Editor Steve Usdin discusses the latest developments for the Inflation Reduction and the Biosecure acts as well as the benefits of the breakthrough therapy pathway. Also on BioCentury.com, listeners may want to check out Danielle Golovin’s analysis of LNP innovation and Paul Bonanos’ take on Monday’s $3.2 billion M&A move by Eli Lilly. This episode of BioCentury This Week was sponsored by Nxera Pharma. View full story: https://www.biocentury.com/article/652898 00:01 - Sponsor Message: Nxera Pharma 01:24 - U.K. Biopharma 08:14 - IRA 10:28 - Biosecure Act 14:49 - Breakthrough Designation Pathway Reach us by sending a text

The impact on FDA and the biopharma industry of the Supreme Court’s move to overturn the legal doctrine that courts defer to federal agencies’ interpretations of ambiguous laws will take years to come into focus; for now, the clearest effects of the Chevron ruling will be on disputes over exclusivity and other non-science issues. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the court’s decision, including how FDA could adjust how it operates. The editors also discuss tumor cell surface targets off the beaten path, and BioCentury’s Q&A with Lurie Prize winner Howard Chang about how his lab, and the five companies he has co-founded, have turned serendipitous discoveries about poorly understood nucleic acid types into translational strategies. This episode of BioCentury This Week was sponsored by Nxera Pharma. View full story: https://www.biocentury.com/article/652845 00:01 - Sponsor Message: Nxera Pharma 04:49 - Chevron Ruling's Impact 10:32 - Tumor Cell Surface Targets 15:48 - Lurie Winner: Howard Chang Reach us by sending a text

A biomarker breakthrough could shave years off the development of therapies for a group of devastating, progressive ultrarare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss FDA’s agreement to allow biopharma companies to use a biomarker as the basis for accelerated approval of neuronal mucopolysaccharidoses therapies, which marks an important inflection point, both for MPS and rare diseases in general. The editors also assess FDA’s decision to grant full approval to and expand the label of Sarepta DMD gene therapy Elevidys delandistrogene moxeparvovec, igniting another controversy over the agency's decision-making; discuss how human genetics is promising to remove some of the risk from neurology drug development; and preview BioCentury’s new conference, Grand Rounds, which takes place in September in Nashville, at the interface of academia and industry. This week’s podcast is sponsored by Nxera Pharma. View full story: https://www.biocentury.com/article/652789 00:01 - Sponsor Message: Nxera Pharma 02:05 - Introducing BioCentury's Grand Rounds 06:46 - An MPS Breakthrough 14:12 - Sarepta Approval Reach us by sending a text

After whisking through Washington for the first half of the year, raising alarms, mutating and causing confusion, the Biosecure Act is now on pause. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the delay for the legislation, which seeks to drive Chinese contract development and manufacturing organizations out of the U.S., means, what will happen next, and how it will impact life sciences companies. View full story: https://www.biocentury.com/article/652771 03:09 - What's In, What's Out 05:41 - Broader Impact 11:07 - Wake-up Call Reach us by sending a text

The avian flu outbreak is a fire drill that is showing how poorly the U.S. is prepared for the next pandemic. On the latest BioCentury This Week podcast, BioCentury's editors recap last week’s BioCentury Show conversation with Rick Bright, including the former BARDA director’s insights on the opportunities for biotechs to help fill voids in surveillance, point-of-care diagnostics, vaccines and therapeutics and the need for the government to provide leadership and funding to empower industry. They also discuss new SEC rules that will make reverse mergers less attractive; the Supreme Court’s mifepristone ruling and a trio of neuro-focused stories -- one on FDA’s guidance on presymptomatic Alzheimer’s, another on an advisory committee’s discussion about Eli Lilly's anti-amyloid therapy donanemab and a third focused on what neuroscience biotech companies need to consider when pitching VCs and pharmas. This week’s podcast is sponsored by Nxera Pharma. 0:01 - Sponsor Message: Nxera Pharma 01:40 - Pandemic Prep Problems 11:11 - Reverse Mergers 15:43 - Alzheimer's 25:31 - SCOTUS Reach us by sending a text

BIO’s annual meeting took place amid heightened industry concerns regarding the Biosecure Act, which took yet another unexpected turn this week. On a special edition of the BioCentury This Week recapping the meeting, BioCentury's editors discuss the latest on the anti-China biopharma legislation, including misperceptions of what the bill seeks to accomplish. Special guest Chris Cargill, the CEO of Nxera Pharma, joins the podcast to discuss the expanded APAC presence at this year’s BIO; Japan’s push to build the biotech ecosystem in the country; and how Nxera (formerly Sosei) is evolving. And finally, BioCentury’s editors deliver the takeaways from Karen Tkach Tuzman’s BIO panel focused on radiopharmaceuticals, including debate on the merits of long- versus short-lived radioisotopes. This week’s podcast is sponsored by Nxera Pharma. View full story: https://www.biocentury.com/article/652686 00:01 - Sponsor Message: Nxera Pharma 02:34 - BIO Wrap: Biosecure  09:12 - Japan & Nxera 18:52 - Radiopharma  Reach us by sending a text

A snub by an FDA advisory committee for an MDMA-psychotherapy combination is unlikely to read through to other psychedelic therapies in the pipeline. On the BioCentury This Week podcast, BioCentury’s editors discuss the shortcomings of the Lykos Therapeutics product’s clinical development program and why other psychedelics likely won’t face the same hurdles. The editors also assess FDA’s new platform technology designation and the first-in-human clinical trials described at this year’s American Society of Clinical Oncology (ASCO) meeting. This week’s podcast is sponsored by Nxera Pharma. View full story: https://www.biocentury.com/article/652639 00:01 - Sponsor Message: Nxera Pharma 01:41 - Psychedelic Setback 12:38 - FDA's Platform Play 21:39 - ASCO Innovations Reach us by sending a text

Four takeouts with upfront payments north of $1 billion to close out May mark the latest run of VC exits from biotech M&A and help expand the pipelines of large biopharmas in renal, ophthalmic and immunologic indications. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how two of the takeouts -- Asahi Kasei’s buy of Calliditas and Biogen’s acquisition of HI-Bio -- showcase how the renal field is on the rise. Turning to Washington, the editors explain why the House Select Committee on the Chinese Communist Party is expanding its remit to Chinese therapeutic developers and commercial competitiveness — with an initial focus on Legend and GenScript. And, finally, they assess data from ASCO that demonstrate how immunotherapies are making progress in “cold” colorectal cancers. This week’s podcast is sponsored by Nxera Pharma. View full story: https://www.biocentury.com/article/652597 00:01 - Sponsor Message: Nxera Pharma 1:35 - Biotech M&A 11:40 - Biosecure Act 23:00 - ASCO Reach us by sending a text

A theme among late-breaker presentations at this year’s American Society of Clinical Oncology meeting is the push by companies to move targeted therapies into earlier lines of treatment. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what they’re watching for in ASCO’s headline presentations and deliver highlights from abstracts released late last week as the oncology meeting readies to kick off on Friday. The editors also discuss the interest by FDA’s Janet Woodcock in a new approval pathway for ultrarare therapies, the Foundation for the National Institutes of Health’s initiative to support development of therapies and diagnostics for ALS, and Biogen's $1B+ acquisition of HI-Bio. This week’s podcast is sponsored by Nxera Pharma. View full story: https://www.biocentury.com/article/652531 0:01 - Sponsor Message: Nxera Pharma 1:43 - ASCO 6:46 - Ultrarare Diseases 14:52 - FNIH's ALS Push 20:27 - Biogen M&A Reach us by sending a text

New BIO CEO John Crowley is reorganizing BIO in a bid to reshape how the organization communicates and enhance its focus on patients. BioCentury’s editors also recap the 24th annual Bio€quity Europe conference that was held in San Sebastián, Spain last week, as well as highlights from last week’s American Society of Gene and Cell Therapy conference. The editors also discuss impressive early data from Endeavor BioMedicines in idiopathic pulmonary fibrosis and Phase Ib obesity data from Roche. This week’s podcast is sponsored by Nxera Pharma. View full story: https://www.biocentury.com/article/652453 0:01 - Sponsor Message: Nxera Pharma 1:08 - BioEquity Europe recap 7:08 - Shake up at BIO 13:37 - ASGCT highlights 20:39 - Endeavor IPF data 22:20 - Roche obesity data Reach us by sending a text

“I’m a short-term pessimist and a long-term optimist” about the potential for AI to transform drug development, Derek Lowe, author of the In the Pipeline blog, told BioCentury Washington Editor Steve Usdin on the latest BioCentury Show. Lowe's skepticism about claims that AI will rapidly transform the field is driven by a belief that the “problems that we have in the drug industry that we want to solve are almost inversely proportional to the ability of AI to solve them." Lowe also discussed the Biosecure Act and U.S. reliance on Chinese contract manufacturing and development organizations; talked about why he hopes and believes the Supreme Court will rule for FDA in litigation over the abortion drug mifepristone; and explained his view that approval of Aduhelm to treat Alzheimer’s disease was one of FDA’s worst decisions. The BioCentury Show is now available as an audio podcast. The Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.  View full story: https://www.biocentury.com/article/652427 00:00 -  The BioCentury Show Podcast  01:51 - Lowe’s Blog 05:30 - Biosecure Act 09:53 - AI & Drug Discovery 17:33 - FDA, The Abortion Drug, & Aduhelm 22:05 - Lessons from COVID Reach us by sending a text

Lawmakers’ changes to the Biosecure Act create breathing room for U.S. biopharma companies to move on from Chinese CDMOs, Washington Editor Steve Usdin said. On the latest BioCentury This Week podcast, Usdin and his BioCentury colleagues discuss what the revisions mean for biotechs and what’s next for the legislation, plus how WuXi AppTec is defending itself against the bill’s allegations. Director of Biopharma Intelligence Paul Bonanos discusses last week’s surge in venture activity, including the largest biotech round, a $200 million series C by Lonnie Moulder’s Zenas BioPharma, as well as recent deals of note, including one for Maze Therapeutics. The biotech found a new partner for its Pompe disease program in Shionogi, months after Sanofi pulled out of a deal for the therapy amid FTC scrutiny. This week’s podcast is sponsored by Nxera Pharma. View full story: https://www.biocentury.com/article/652402 00:01 - Sponsor Message: Nxera Pharma 03:24 - Biosecure Revisions 09:34 - WuXi AppTec Responds 14:42 - Venture Raises 19:32 - Deals of Note Reach us by sending a text

It sounds obvious, but still needs saying, says Ysios Capital's Karen Wagner. “How do you rise above the noise? By having the most spectacular data.” In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Wagner discussed the theme of the upcoming Bio€quity Europe conference — rising above the noise: in a sea of competition where companies vie for attention among investors and pharmas, what are the characteristics that allow them to differentiate? Wagner explains what she and her team looks for in a biotech before investing, and also discusses the role of ESG policies, including diversity, in companies. “We have absolute certainty that ESG is important." The BioCentury Show is now available as an audio podcast. The Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel. View full story: https://www.biocentury.com/article/652294 00:00 - The BioCentury Show Podcast 02:12 - Spain’s Biotech Ecosystem 10:06 - Investment Criteria 15:03 - ESG, Diversity 28:29 - AI in Drug Development Reach us by sending a text

Next week's Bio€quity Europe conference in San Sebastián will focus on how European biotechs can rise above the noise to attract investors, partners and talent. McKinsey & Co.’s Alexandra Zemp and Paula Olazábal of Ysios Capital joined BioCentury to outline the opportunities and challenges faced by Spain’s biopharma ecosystem and preview some of the conference’s networking events, fireside chats and panel discussions. EBD Group's Claire Macht also joined to detail what to expect in terms of attendees and one-on-one partnering meetings at the event. Bio€quity Europe 2024 is sold out, but space on the waitlist remains, and digital passes are available. See the conference website for more information. View full story: https://www.biocentury.com/article/652371 00:00 - Intro 03:27 - Spanish Biotech Ecosystem 08:13 - McKinsey's Insights 12:08 - Event Preview 17:26 - BioЄquity Europe C-Level Attendees Reach us by sending a text

One of the big themes of this week’s ASGCT meeting will be CAR T cells in cancer and beyond. On the latest BioCentury This Week podcast, BioCentury’s editors preview the American Society of Gene and Cell Therapy’s annual meeting. Much of the CAR T field has reoriented from cancer to autoimmune diseases over the past year. Now, researchers are looking even farther afield. According to abstracts released ahead of ASGCT, the engineered T cell modality may have new benefits to offer patients with asthma, Duchenne muscular dystrophy or HIV. The editors also discuss a study aiming to quantify the benefits accelerated approval has had for cancer patients, and what’s next for the Biosecure Act and similar legislation seeking to rein in Chinese CDMOs and genomics companies. This week’s podcast is sponsored by Nxera Pharma. Don’t miss BioCentury’s new podcast, The BioCentury Show, featuring BioCentury one-on-one with an industry KOL. It’s available wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel. View full story: https://www.biocentury.com/article/652335 00:01 - Sponsor Message: Nxera Pharma 01:43 - ASGCT Preview 10:37 - BioCentury Show Podcast 14:21 - Accelerated Approval  19:48 - Biosecure: What’s Next Reach us by sending a text

Led by CBER Director Peter Marks, FDA is moving forward with policies that aim to improve access to gene therapies for patients with rare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how FDA plans to use regulatory policies to overcome barriers that are slowing gene therapy, as well as how Pfizer hopes to ensure access to its newly approved hemophilia gene therapy. The editors also assess the $2.4 billion acquisition of Massachusetts oncology company Deciphera by Japan’s Ono as it seeks to diversify its pipeline beyond Opdivo and expand its global footprint. They also discuss the $1 billion launch of AI-guided therapeutics developer Xaira. Finally, BioCentury’s Joshua Berlin joins the podcast to preview BioCentury’s upcoming conference Bio€quity Europe, which kicks off May 12 in San Sebastián. This week’s podcast is sponsored by Jeito Capital. View full story: https://www.biocentury.com/article/652273 0:01 - Sponsor Message: Jeito Capital 1:55 - Energizing Gene Therapy 6:28 - Pfizer Hemophilia Approval 11:36 - Bio€quity Europe Preview 18:03 - Arch & Foresite's AI Biotech Build 19:32 - Ono's Deciphera Takeout Reach us by sending a text

A “drive-by analysis of accelerated approval is intellectual malpractice,” argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues explain why a paper on the expedited regulatory pathway written by researchers at the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital misleads the public about the value of drugs granted accelerated approval. The paper also fails to grasp the pathway’s purpose, which is “to allow risk-taking when there’s evidence that a therapy is reasonably likely to benefit patients who are suffering from a serious condition,” Usdin writes in the Editor’s Commentary. BioCentury’s editors also discuss how an FDA advisory committee’s support for a myeloma metric makes the broader case for endpoint innovation; why a group of biotechs is delisting from U.K. stock exchange AIM; and the launch of well-funded obesity play Metsera Inc. For more of BioCentury’s coverage of obesity therapeutics, see our Hot Topics page. This week’s podcast is sponsored by Jeito Capital. View full story: https://www.biocentury.com/article/652185 0:01 - Sponsor Message: Jeito Capital 1:54 - Defending Accelerated Approval 8:44 - Endpoint Innovation 12:55 - Challenges for U.K.'s AIM 18:16 - Obesity Launch: Metsera Reach us by sending a text

Vertex Pharmaceuticals' acquisition of Alpine Immune Sciences will bolster a growing kidney disease franchise that could help diversify Vertex’s business beyond its blockbuster cystic fibrosis franchise. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what attracted Vertex to Alpine and why it believes its newly acquired therapy can outshine others for IgA nephropathy. The editors discuss how Goldman Sachs aims to scale private biotechs via its venture strategy and the likely key factors for CMS as it determines prices for the first cohort of drugs in Medicare drug price negotiations under the Inflation Reduction Act. They also preview BioCentury’s first R&D conference — Grand Rounds — which will focus on the biotech industry’s interface with academia, bringing together decision-makers and the next innovators in Nashville, Sept. 9-11. This week’s podcast is sponsored by Jeito Capital. View full story: https://www.biocentury.com/article/652107 0:01 - Sponsor Message: Jeito Capital 1:30 - Introducing BioCentury's Grand Rounds 3:59 - Vertex’s Alpine Takeout 9:38 - Goldman’s Venture Strategy 14:33 - Reading the IRA Tea Leaves Reach us by sending a text

M&A has been driving a recovery for biotech, with $62 billion in takeouts in the past six months restocking specialist investors’ coffers for their next wave of investments. On the latest BioCentury This Week podcast, BioCentury’s editors assess the state of the public markets heading into the second quarter, including the outsize role PIPEs have had in financing industry’s comeback. They also discuss their takeaways from analyzing nearly 7,000 abstracts from the American Association for Cancer Research and the editors’ insights on why degrader-antibody conjugates are emerging as the next contenders to build on the success of the antibody-drug conjugates paradigm. Editor in Chief Simone Fishburn also previews Grand Rounds, BioCentury’s first R&D conference, which will focus on the biotech industry’s interface with academia, bringing together decision-makers and the next innovators in Nashville Sept. 9-11. To learn more about BioCentury Grand Rounds and opportunities to present, see the conference website. This week’s podcast is sponsored by Jeito Capital. View full story: https://www.biocentury.com/article/651996 0:01 - Sponsor Message: Jeito Capital 1:15 - Introducing BioCentury's Grand Rounds 3:53 - 2Q Markets Preview 12:48 - AACR Takeaways 15:46 - ADCs & DACs Reach us by sending a text

Upcoming catalysts could drive value creation at NASDAQ’s newest biotech, Boundless Bio, after it stumbled in its trading debut last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss Boundless’ IPO in the context of the current market for fresh paper and profile the “sweat equity” model of Avalon, the VC firm led by Jay Lichter. Turning to Washington, BioCentury’s editors assess possible outcomes for the Supreme Court case on abortion drug mifepristone, and why the court’s pending decision could safeguard FDA from judicial second-guessing. The team also analyzes the agency’s first ever complete response letter for lack of confirmatory trial enrollment.  This week’s podcast is sponsored by Jeito Capital. View full story: https://www.biocentury.com/article/651937 0:01 - Sponsor Message: Jeito Capital 4:15 - Biotech IPOs 7:50 - Avalon BioVentures 11:14 - FDA at SCOTUS 16:29 - Confirmatory Trials Reach us by sending a text

Bills seeking to rein in Chinese CDMOs and genomics companies will deal a massive blow to biotech companies, if passed in their current form, according to results from an industry survey conducted by BioCentury. On The latest BioCentury This Week podcast, BioCentury’s editors discuss results from the survey, including responses that underscore executives’ concerns that the legislation would cause delays in drug development and a majority’s displeasure with BIO’s about-face to support the measures. They also discuss takeaways from Editor in Chief Simone Fishburn’s conversation on The BioCentury Show with Atlas Venture’s Bruce Booth, and lessons from Orchard Therapeutics on what it takes to get FDA’s approval for an ultrarare disease drug. For BioCentury’s complete coverage of the Biosecure Act and similar legislation in Senate, visit the Hot Topics page for the topic Reach us by sending a text

Putting patients at center stage is at the core of John Crowley’s vision for BIO as he begins his tenure leading the biotech trade group. On the latest BioCentury This Week podcast. Washington Editor Steve Usdin details Crowley’s plans to revitalize BIO at a time when effective representation in Washington is more important than ever. BioCentury’s editors also discuss FDA’s landmark approval of Madrigal's liver disease drug and a decision by FDA’s Oncologic Drugs Advisory Committee to support a pair of BCMA-directed CAR T cell therapies in earlier lines to treat multiple myeloma, and what’s needed to help avoid deaths during the period while patient wait for the CAR T cells to be produced. Reach us by sending a text

A congressional committee meeting last week on biotech and national security provided a glimmer of hope that lawmakers could be persuaded to consider taking steps to bolster the U.S. bioeconomy, BioCentury Washington Editor Steve Usdin explains why the at times cartoonish spectacle of lawmakers pushing anti-China biotech bills highlights the need for scientists and entrepreneurs to build relationships in Washington. Plus: Editor in Chief Simone Fishburn argues that the future of diversity should not be bound up in the fate of DEI. And BioCentury's editors discuss the pivotal trial setback for Amylyx in ALS and what may be on FDA’s agenda as is schedules an advisory meeting for Lilly's Alzheimer's therapy donanemab. Reach us by sending a text

The $3 billion raised by biotechs in a series of follow-ons and PIPEs last week marked another strong showing for a sector seeking to outrun the bear market. On the latest BioCentury This Week podcast, BioCentury’s editors assess the state of fundraising for biotechs and their performance in the after-market. They also preview a forthcoming analysis of preclinical papers published in the Distillery, BioCentury’s coverage of translational science, describe the latest on anti-China bills in Congress and Inflation Reduction Act litigation, and discuss Closed Loop Medicine’s program that seeks to bring precision medicine to obesity. Reach us by sending a text

Asia’s emerging “Arc of Innovation” spans from China, Japan and South Korea through the turf-neutral gateway of Singapore and west to India, with the ecosystems of these countries contributing to the arsenal of therapeutics and diagnostics that benefit patients globally. On a special edition of the BioCentury This Week podcast, Aslan’s Carl Firth, McKinsey’s Franck Le Deu and Wendy Pan of BayHelix and Goodwin join BioCentury on the eve of next week’s BioCentury-BayHelix Biopharma Summit in Singapore to discuss innovation across Asia, rising East-West deal flow and the opportunities and challenges faced by the region’s various biotech ecosystems. They also detail highlights among the speakers, panels and fireside chats of the three-day event. Join BioCentury, BayHelix and McKinsey March 4-6 in Singapore or virtually for the third East-West Biopharma Summit. Reach us by sending a text

 Arch Venture Partners’ Bob Nelsen is excited about AI’s potential in biotech and convinced the U.S. healthcare system could do a far better job delivering on the promise of the biopharma industry’s innovations. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from Nelsen’s appearance on The BioCentury Show, including how the longtime investor in China’s life sciences sector has adopted a more cautious stance on the country given increasing geopolitical tensions. BioCentury’s editors also discuss whether TL1A inhibitors are poised to bring precision medicine to large inflammatory and autoimmune indications, and why participants in a Feb. 21 Reagan-Udall Foundation workshop hope the meeting could help establish precedents that will revitalize the development of effective treatments for extremely rare diseases.  Music for The East-West Biopharma Summit: Singapore teaser: Composed by: Moa Michaeli Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images Reach us by sending a text

Off switches and non-viral delivery technologies may be the solution to CAR T therapies’ most recent safety problem. On the latest BioCentury This Week podcast, BioCentury’s editors discuss alternative CAR T technologies already in development that avoid or reduce the risk of secondary malignancy. The editors also discuss the world-first approval of Iovance's tumor-infiltrating lymphocyte (TIL) therapy, highlights from BioCentury’s most recent survey of the translational literature in the Distillery, and the path to approval for Sarepta's Elevidys delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy. Music for The East-West Biopharma Summit: Singapore teaser: Composed by: Moa Michaeli Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images Reach us by sending a text

Anti-China biotech bills are raising alarms at U.S. biotechs, with CEOs worried they could lose access to CDMOs WuXi AppTec and WuXi Biologics, and that legislation could imperil collaboration with Chinese companies more broadly. BIO has warned Congress the bills “would immediately and negatively” affect the U.S. biotech ecosystem. On this special edition of the BioCentury This Week podcast BioCentury Washington Editor Steve Usdin and colleagues discuss the pending legislation. Reach us by sending a text

Innate immunity is getting another shot at cancer through antibody-drug conjugates, with immunostimulatory antibody-drug conjugates moving from concept to clinical product. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the therapies work and what sets them apart from conventional ADCs. The editors also survey the companies developing psychedelic therapies that aim to overcome the difficulties of the business model, and assess Gilead's $4.3 billion takeout of liver disease company CymaBay, and the performance of IPOs by genomic editing tools company Metagenomi and immunology company Kyverna. Music for The East-West Biopharma Summit: Singapore teaser: Composed by: Moa Michaeli Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images Reach us by sending a text

As it approaches a steep patent cliff, Bristol Myers is charting its course to bridge a transition period and return to growth. On the latest BioCentury This Week podcast, BioCentury’s editors assess the pharma’s pipeline and recent M&A, outlining the clinical and commercial successes the company needs to navigate the next few years. The editors also discuss what’s behind bills in Washington that target four Chinese companies identified by Congress as “biotechnology companies of concern," the latest biotech IPOs, and the innovation behind last year’s biotech series A raisers. Music for The East-West Biopharma Summit: Singapore teaser: Composed by: Moa Michaeli Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images Reach us by sending a text

NASDAQ’s first biotech public listings of 2024 provided hopeful signs for a rebound in the biotech IPO market. On the latest BioCentury This Week podcast, BioCentury’s editors assess the performance of IPOs by CG Oncology and ArriVent and what’s next for the IPO market. They also discuss the growing IL-18 field, look ahead to the schizophrenia milestones coming this year, and size up the Singapore biotech ecosystem and what the country needs to do to cement a position on the global biotech map. Music for The East-West Biopharma Summit: Singapore teaser: Composed by: Moa Michaeli Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images Reach us by sending a text

Biotech investors are looking to catalysts that can create, or dramatically expand, commercial markets as they look ahead to a long-awaited recovery for industry. On the latest BioCentury This Week podcast, BioCentury’s editors assess the milestones on buysiders’ radar for 2024, including in areas such as obesity, pain and metabolic-associated steatohepatitis (MASH). They also discuss the influence of biopharma critic Arnold Ventures, a philanthropy that has reshaped the drug pricing public policy landscape; lung cancer data for Gilead's Trodelvy; and the week's expected biotech IPOs.  Music for The East-West Biopharma Summit: Singapore teaser: Composed by: Moa Michaeli Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images Reach us by sending a text

Investors and bankers are as upbeat about biotech’s prospects heading into 2024 as they have been since 2020, but maintaining the momentum that began building in 4Q23 is contingent on the Fed meeting expectations that it will ease interest rates. On the latest BioCentury This Week podcast, BioCentury’s editors assess the environment for financings and M&A in the year ahead. They also discuss Janet Woodcock’s legacy at FDA as she readies to step down at the end of the month and the latest developments in the abortion drug case. Music for the 24th Bio€quity Europe teaser produced by: Thomas de Paula Eby, Andreas Unge, Epidemic Sound via Getty Images Reach us by sending a text

Cautious optimism was the theme during a J.P. Morgan Healthcare Conference week that featured patchy skies, large-but-not-mega deals and a surfeit of sideline summits around San Francisco’s Union Square. BioCentury’s editorial team discusses the week’s M&A deals, including J&J's $2 billion takeout of ADC company Ambrx, and Merck & Co. acquiring T cell engager biotech Harpoon for nearly $700 million; takeaways from the Sachs Neuroscience Innovation Forum and other adjacent forums; and investor sentiment heading into the New Year. Music for the 24th Bio€quity Europe teaser produced by: Thomas de Paula Eby, Andreas Unge, Epidemic Sound via Getty Images Reach us by sending a text

A flurry of large acquisitions to close out 2023 is likely to carry into the New Year as pharmas continue to show appetite for late-stage assets. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the latest trends in biotech M&A, potential takeout targets for 2024 and the impact on dealmaking of a more aggressive FTC. They also assess sentiment heading into next week’s J.P. Morgan Healthcare Conference, analyze future drivers of innovation in biotech, and preview the year ahead in regulation and public policy. Music for the 24th Bio€quity Europe teaser produced by: Thomas de Paula Eby, Andreas Unge, Epidemic Sound via Getty Images Reach us by sending a text

Signals from the Fed that rate cuts are on the way rallied biotech indexes last week, but is the uptick more than a blip? On the latest BioCentury This Week podcast, BioCentury’s editors discuss how interest rate cuts could spur a risk-on rotation back into the sector by generalist investors, the possibility of biotech outperformance in 2024, and what it will take for the IPO window to open. They also assess progress demonstrated by companies’ with next-generation gene editors at this year’s American Society of Hematology (ASH) meeting, as well as BioCentury’s analysis of new targets at the conference. The editors also offer their picks for the highlights (and lowlights) of 2023 and predictions for what’s in store in the New Year. Reach us by sending a text

FDA’s decision to approve two gene therapies for sickle cell diseases could be transformative for patients, but both multimillion-dollar drugs will face access issues. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what’s next for the companies, and for patients, following the approvals. The editors also analyze how AbbVie is restocking its pipeline via M&A, including its second multibillion deal in a week, a takeout of Cerevel, and why the acquisition is important beyond the pharma’s own portfolio. And Washington Editor Steve Usdin assesses BIO’s decision to name John Crowley as its new CEO and why the Biden administration’s new march-in policy is likely to affect very few drugs.  Reach us by sending a text

Biopharma’s latest pair of multibillion-dollar takeouts come in two of industry’s hottest areas: ADCs and obesity. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the move by Roche into obesity via its acquisition of Carmot Therapeutics and the winding journey of ADC company ImmunoGen to its $10.1 billion buyout by AbbVie. BioCentury’s editors discuss what FDA’s statement on the risk of T cell malignancy following BCMA- or CD19-directed CAR T cell therapy means for companies operating in the space. Reach us by sending a text

Radiopharmaceuticals have experienced a resurgence over the past decade, with a series of approvals, billion-dollar deals and growing sales. On the latest BioCentury This Week podcast, Director of Biopharma Intelligence Karen Tkach Tuzman previews her upcoming analysis of the space, discussing the multidimensional nature of the technology’s evolution, and the field’s next-wave targets behind PSMA and SSTR2. BioCentury’s editors also discuss the legacies of two U.S. lawmakers who won’t stand for re-election, Reps. Anna Eshoo (D-Calif.) and Michael Burgess (R-Texas); the latest move by BioNTech to grow its global footprint; and the November rise in the XBI. Reach us by sending a text

The world’s first approval of a CRISPR-based gene editing therapy, granted by the U.K.’s MHRA, was a milestone for the technology that was just discovered about 12 years ago. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the implications of the landmark and the challenges that still face partners Vertex Pharmaceuticals and CRISPR Therapeutics in launching and scaling the rollout of Casgevy exagamglogene autotemcel (exa-cel) in the U.K. and beyond. The editors also discuss the unintended consequences of the Inflation Reduction Act (IRA) on the development of orphan drugs and new legislation that aims to address the problem by providing an exemption to price negotiations for therapies that are approved only for orphan indications, regardless of how many. The team also reflects on the legacy of FDA’s Janet Woodcock ahead of her planned retirement next year; the sentiment coming out of last week’s Jefferies Healthcare Conference in London; and the aftermarket performance of two market debuts last week from antibody-drug conjugate CMO WuXi XDC Cayman and Mural Oncology. Reach us by sending a text

Verve achieved the first proof of concept for an in vivo base editing therapy, but investor concerns weighed on the company’s stock, clouding the readout’s reception. On the latest BioCentury This Week podcast, BioCentury’s editors dissect the data for VERVE-101 in heterozygous familial hypercholesterolemia and discuss how the choice of initial target and indication for a new modality or technology can have a major impact on how POC data are perceived by investors. The editors also assess the latest developments related to the Inflation Reduction Act and assess a selection of biopharma deals and IPOs. Reach us by sending a text

The controversy around Sarepta continues as the company’s executives were confident last week that the data from the Phase III EMBARK trial of Duchenne muscular dystrophy gene therapy Elevidys were enough to warrant full approval despite missing the study’s primary endpoint. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the pitfalls facing FDA as the agency considers whether to apply regulatory flexibility in its decision-making and the impact its decision could have for patients and future therapies that are submitted to the agency with less than clear-cut positive data. The editors also discuss innovations around new endpoints and technologies for clinical trials and the tepid reception for the latest biotech IPO, the debut by Lexeo. Reach us by sending a text

The European Society for Medical Oncology (ESMO) had everything from practice changing Phase III data readouts to new solid tumor targets. On the latest BioCentury This Week podcast, BioCentury’s editors recap the biggest data presentations from last week’s annual ESMO meeting, including the impact of Phase III data for ADCs and bispecifics on the treatment landscape for tumors such as urothelial cancer and EGFR-mutant non-small cell lung cancer (NSCLC). The editors also discussed takeaways from the most recent progress in the confirmation of Monica Bertagnolli as director of the National Institutes of Health (NIH), and the latest step CMS has taken in implementing the Inflation Reduction Act (IRA). They also discussed Abingworth’s new $356 million co-investment fund, which, coupled with its 2021 vintage co-development fund, brings the VC firm’s firepower for investing in late-stage development programs to nearly $1 billion. Reach us by sending a text

Daiichi Sankyo has drawn more value from its antibody-drug conjugate pipeline via a $4 billion deal with Merck & Co. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the deal in the context of the burgeoning ADC space and size up the assets that Merck is in-licensing as well as how the deal fits with Daiichi’s pipeline strategy. The editors break down Monday’s $7.1 billion deal by Roche for the Telavant subsidiary of Roivant Sciences, the latest in the evolving TL1A space; and offer highlights from BioCentury’s deep dive into how academics and biotechs are expanding the therapeutic potential of base editors. Reach us by sending a text

BayHelix’s Guo-Liang Yu and McKinsey’s Josie Zhou join the BioCentury This Week podcast to discuss cross-border innovation and deal flow in the biopharma sector during a preview of the BioCentury-BayHelix China Healthcare Summit. The summit kicks off at a time of record cross-border deals and validating comments from the leaders of MNCs such as Pfizer, Novartis and Sanofi that innovation by China biopharmas is world class. The 10th annual BioCentury-BayHelix China Healthcare Summit is Nov. 2-3 in Shanghai. Digital passes are also available. Reach us by sending a text

Now that Vas Narasimhan has finished the major dismantling of Novartis, he’s turning his attention to fixing R&D. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what’s next for the Swiss pharma now that Narasimhan has focused it down to what he calls a pure play innovative medicines company. The editors also analyze the European Parliament’s proposed changes to the first major overhaul of European pharmaceutical law in 20 years, including suggested adjustments related to data exclusivity, orphan drugs and antimicrobials. They also discuss what Novo Nordisk gains via a deal with Singapore’s KBP BioSciences and how the Inflation Reduction Act has prompted Relay Therapeutics to delay development of lirafugratinib (RLY-4008) to treat cholangiocarcinoma in favor of a larger indication Reach us by sending a text

BMS’s acquisition of Mirati for up to $5.8 billion not only gives the big pharma a potential best-in-class KRAS inhibitor in a field that appears to be opening up, but also a clinical program against one of the hottest targets in precision cancer, PRMT5. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what Bristol Myers Squibb stands to gain from its acquisition of Mirati Therapeutics, which had rumors swirling about its potential takeout last week.  BioCentury’s editors also discuss their 4Q23 Public Markets Preview, including how private biopharma companies looking to go public in the next 12 months should be managing their path to that transition. Following last week’s analysis of the companies leading the transition of CAR T therapies into the autoimmune space, BioCentury’s editors also touch on the targets and technologies coming up behind the leading programs that could expand use of CAR Ts to a wider set of autoimmune indications.  They also discuss takeaways from ICER’s report on how CMS might approach drug price negotiation under the Inflation Reduction Act. Reach us by sending a text

Biopharma companies are moving quickly to figure out how to optimize CAR T cell therapies for autoimmune diseases now that it’s becoming clear the modality has clinical activity and possibly even curative potential in the disease area. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the trigger for this surge of interest, the indications, targets and companies in play and whether the technology can meet the higher safety bar in autoimmune indications. BioCentury’s editors also discuss takeaways from BioCentury’s recent conversation with Sanofi CEO Paul Hudson; the latest developments for the Inflation Reduction Act; and notable biotech financings, including a $300 million private placement for Structure Therapeutics. Reach us by sending a text

BayHelix’s Guo-Liang Yu and McKinsey’s Olivier Leclerc join the BioCentury This Week podcast to discuss cross-border innovation and deal flow in the biopharma sector and preview the upcoming BioCentury-BayHelix East-West Summit. Yu discusses the importance of the event for BayHelix, and Leclerc previews McKinsey’s second East-West Summit report, which will focus on the impact of AI on the sector. BioCentury co-founder, President and CEO Dave Flores, Editor in Chief Simone Fishburn, and head of BD Josh Berlin also join the podcast to discuss the importance of globalization for biopharma and patients, the growth of cross-border dealmaking, and panel topics and speakers at the East-West Summit, which takes place Oct. 2-4 in Kendall Square. Reach us by sending a text

That a broad swath of new money flowed into last week’s IPOs by RayzeBio and Neumora is a good sign for biotech and a departure from deals done last year, BioCentury's Stephen Hansen said on the latest BioCentury This Week podcast. Hansen and colleagues assess the offerings and the companies’ aftermarket performance alongside NASDAQ’s six other top biotech IPOs of the year for signs of what’s next for companies looking to go public. BioCentury’s editors also discuss what new regulatory requirements in China mean for Chinese biotechs hoping to debut on a stock exchange in the near future, as well as the latest developments in lawsuits related to the Inflation Reduction Act and an upcoming hearing on the IRA in the House. Reach us by sending a text

Constructing deal terms to take advantage of both the translational research benefits in China and the market opportunity in the U.S. is slowly emerging as a strategy to advance CAR T cell innovation. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how deals for the technology have evolved since the 2017 partnership between Legend and Janssen for Carvykti and the opportunity for East-West collaborations to drive CAR T cell development. BioCentury’s editors also assess why the FTC made a deal with Amgen that will allow the company’s $27.8 billion acquisition of Horizon Therapeutics to proceed, and how an agreement by Regeneron on international pricing of a COVID-19 mAb could clear the path to confirmation of Monica Bertagnolli as the next NIH director. Reach us by sending a text

What are the criteria that enable companies to achieve the kind of success that leads to a jump in market cap tier? On the latest BioCentury This Week podcast, BioCentury’s editors discuss Back to School 2023, which examines the ingredients for building long-term, sustainable, high-value biotech companies. Reach us by sending a text

Circular RNA’s durability could convey efficacy and manufacturing advantages over therapies based on linear mRNA. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the rising therapeutic modality, with a look at the technology, companies and investors in the space. They also assess the pipeline of psychedelic therapies as the product candidates move toward proof of concept, homing in on psilocybin-based product candidates, which are the most abundant and some of the most advanced. BioCentury Head of Business Development Josh Berlin joins the podcast to preview BioCentury’s upcoming conferences, the Oct. 2-4 BioCentury-BayHelix East West Summit in Cambridge, Mass., and the Nov. 2-3 China Healthcare Summit in Shanghai. Reach us by sending a text

There’s a tectonic shift happening in obesity research and drug development, BioCentury Editor in Chief Simone Fishburn said on the latest BioCentury This Week podcast. Fishburn and colleagues discuss how the success of obesity therapies from Novo Nordisk and Eli Lilly targeting the incretin axis has galvanized a wave of drug development with different molecular targets as well as last week’s threshold-setting cardiovascular outcomes trial data from Novo and recent obesity deals by the two companies. BioCentury’s editors also discuss takeaways from Fishburn’s conversation with Flagship Pioneering’s Noubar Afeyan on The BioCentury Show, plus the Scleroderma Research Foundation’s plans to bring the platform trial model to scleroderma. Reach us by sending a text

A complete response letter from FDA in major depressive disorder could severely dent the commercial prospects for Zurzuvae zuranolone even as the drug gained approval for postpartum depression. On the latest BioCentury This Week podcast, BioCentury’s editors assess what the agency’s decision, which included a request for at least one additional study, means for Biogen and its partner Sage Therapeutics. BioCentury’s editors also discuss the thawing market for biotech IPOs, zeroing in on the dozens of companies that raised crossover cash before markets turned sour, as well as the digital transformation under way at Sanofi, which aims to use AI and data science to drive everything from candidate discovery to clinical trial planning, manufacturing optimization and supply chain management. Reach us by sending a text

An analysis of pharma deal trends over the past year shows a focus on first-in-class assets with autoimmune diseases being a major focus of interest. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal trends mean for prospective pharma partners and whether the expected focus on late-stage products, and a material increase in valuation for late-stage programs, is supported by the data. BioCentury’s editors also talk about a recent conversation with Genentech Inc. CEO Alexander Hardy, and his perspective on how the Inflation Reduction Act (IRA) may impact future decision-making on drug development for small molecules. They also discuss takeaways from a Q&A with Leerink Partners’ Jeffrey Leerink and Dan Dubin, what’s next in BIO’s hunt for a permanent CEO, and the case of Stealth BioTherapeutics Corp. and whether the company’s regulatory experience raises questions about if FDA should improve the consistency with which it applies regulatory flexibility. Reach us by sending a text

A hypertension deal with Roche will help Alnylam execute on its growth strategy of moving into more prevalent diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what the deal does for both companies and why plans for a cardiovascular outcomes trial (CVOT) before the launch of zilebesiran are critical for maximizing the program’s commercial opportunity.BioCentury’s editors also preview this week’s episode of The BioCentury Show, in which Washington Editor Steve Usdin speaks with Alkermes about the politics and policy environment around drug pricing and the Inflation Reduction Act and assess the latest developments in industry litigation against the IRA and new FTC guidelines on antitrust rules. Reach us by sending a text

With investors seeing the worst days fading into the rearview mirror, the sector has begun to chart a path out of the biotech bear market. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the indicators to watch for a recovery as described in the 3Q23 Financial Markets Preview.  They also analyze the latest data from Alzheimer’s therapy donanemab from Eli Lilly, noting it sheds light on which patients stand to benefit from the therapy, and they discuss the pharma’s takeout of Versanis Bio to expand its obesity portfolio and improve the quality of weight loss it can achieve. Reach us by sending a text

Full approval of Leqembi lecanemab-irmb will unlock reimbursement and energize Alzheimer’s R&D, but the launch will be slow, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues break down the takeaways from BioCentury’s interview with Chris Viehbacher, CEO of Biogen, and discuss the challenges of launching a product for a disease that has until now been untreatable. BioCentury’s editors also discussed the prospects for the IPO window in the second half now that the market for follow-on financings is showing signs of life, and the controversy surrounding Elevidys delandistrogene moxeparvovec, the gene therapy from Sarepta Therapeutics for Duchenne muscular dystrophy that Usdin argued in an Editor’s Commentary shows flaws in evidence generation and regulatory processes. Reach us by sending a text

FDA Commissioner Rob Califf’s biggest legacy could be his reform of FDA’s advisory committee process. But what is uncertain is whether his review can bring together enough consensus among agency leaders to drive a meaningful change, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleagues discuss the areas of the U.S. regulator’s advisory committee process where there is — and isn’t — agreement on needed changes, and what could make this time different from a lengthy history of calls for change. BioCentury’s editors also preview an upcoming discussion with Polaris Partners’ Amy Schulman regarding why Singapore, the funding scene, and women in leadership. Usdin then discusses why reimbursing the recently approved DMD gene therapy from Sarepta Therapeutics through state Medicaid plans won’t be so simple. Reach us by sending a text

Emer Cooke may have already cemented her legacy as executive director of EMA through her leadership of the European regulator during the COVID-19 crisis. But she still faces a big task in navigating the agency through Europe’s new pharma legislation, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast.  Usdin and colleagues discuss a wide-ranging fireside chat held last week in Amsterdam with Cooke, including how the agency adapted post-Brexit and the differences that need to be appreciated between the European and U.S. regulators. BioCentury’s editors also discuss the future of induced pluripotent stem cells (iPSCs) in cell therapies, a conversation with Forbion’s Wouter Joustra, a management buyout of SVB Securities, and why Senate Democrats are holding back on confirming a new NIH director. Reach us by sending a text

A lawsuit over the Inflation Reduction Act by Merck & Co. suit signals to Republicans that the pharma has no compunctions about attacking Democrats, the Biden administration and the president himself, said BioCentury Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and colleague discussed the significance of the move by Merck, its likelihood of success and why the pharma chose its combative tone for the first lawsuit challenging the Medicare drug price-setting provisions of the IRA. BioCentury’s editors also assessed remarks at the BIO convention by FDA Commissioner Rob Califf related to the accelerated approval pathway, takeaways from Friday’s FDA panel on Alzheimer’s drug Leqembi and data presented at the American Society of Clinical Oncology annual meeting for multicancer early detection tests. This week’s podcast is sponsored by Cancer Research Horizons. Reach us by sending a text

ASCO’s kickoff included blunt comments from two CEOs who said the IRA is causing their companies to delay launches of cancer drugs for smaller indications, BioCentury Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues discussed remarks at the American Society of Clinical Oncology conference by Novartis' Vasant Narasimhan and Genentech's Alexander Hardy regarding how the Inflation Reduction Act is forcing the companies to make difficult decisions regarding their pipelines and patients’ access to their therapies. The podcast team also assessed highlights from ASCO’s data presentations, including antibody-drug conjugate readouts from partners AstraZeneca and Daiichi Sankyo, and Kelun Pharmaceutical and Merck & Co., as well as the emergence of Alkeus, which has attracted $150 million in series B money for its Stargardt program and Joshua Boger to its executive chairman position. This week’s podcast is sponsored by Cancer Research Horizons. Reach us by sending a text

Two Phase I checkpoint inhibitor readouts due at ASCO 2023 are bringing excitement back to immuno-oncology, said BioCentury’s Lauren Martz on the latest BioCentury This Week podcast. Martz and her editorial team colleagues discuss what stands out about the data for LAG3 inhibitor fianlimab from Regeneron and anti-TIGIT mAb tiragolumab from Genentech. The editors also break down takeaways from BioCentury's conversation on precision neuropsychiatry with Husseini Manji, co-chair of the U.K. Mental Health Mission, and assess BIO’s call for CMS to provide more clarity about its plans for implementing provisions in the Inflation Reduction Act that give some small biotechs a temporary exemption from Medicare drug price negotiation. This week’s podcast is sponsored by Cancer Research Horizons. Reach us by sending a text

If FDA approves Sarepta's gene therapy for Duchenne muscular dystrophy, patients will soon face the difficult choice between taking this treatment or waiting for a better option among the “unprecedented” amount of innovation ahead in DMD, as taking both may not be an option, BioCentury Executive Director Lauren Martz said on the latest BioCentury This Week podcast. Martz and colleagues assess the landscape for DMD gene therapies ahead of the May 29 PDUFA date for delandistrogene moxeparvovec. Also on the show, BioCentury Washington Editor Steve Usdin discusses takeaways from his conversation with FDA's Peter Marks; three tasks for Monica Bertagnolli to prioritize at NIH; and what the debt ceiling means for the life sciences. And on the heels of Bio€quity Europe, Editor in Chief Simone Fishburn delivers her insights from BioCentury’s European conference. This week’s podcast is sponsored by Cancer Research Horizons. Reach us by sending a text

As biotechs continue to find their footing in the new normal of capital scarcity, the industry is beginning to see “green shoots” in M&A activity and preclinical deals, Ysios Capital’s Guillem Laporta said on a special edition of the BioCentury This Week podcast featuring takeaways from the 2023 Bio€quity Europe conference in Dublin. In conversation with BioCentury and Gilde Healthcare’s Joep Muijrers, Laporta described a fundraising environment where disruptive, innovative companies are continuing to get funded. The group also discussed Gilde’s plans for deploying its recent record VC fund, Ysios portfolio company Mineralys’ successful NASDAQ IPO and next year’s Bio€quity Europe conference, scheduled for May 2024 in San Sebastián, Spain. Reach us by sending a text

For many private European biotechs, flat or down valuations have become the new normal as they struggle to raise money despite having quality science, +ND Capital’s Dani Bach said on a special edition of the BioCentury This Week podcast featuring takeaways from the 2023 Bio€quity Europe conference in Dublin. Investors, he said, are flocking to a handful of outsize fundraising rounds out of fear. In conversation Monday with Jeff Cranmer and Stephen Hansen of BioCentury and Poolbeg’s Jeremy Skillington, Bach described a bipolar fundraising environment in which the “bulk of companies are struggling for money and a few are getting massive amounts of money even beyond their wild expectations.” Bach, Skillington and BioCentury's editors also discuss Ireland's burgeoning biotech ecosystem, Europe's biopharma hubs and the performance of U.K.'s biotechs listed on the London Stock Exchange. This episode is sponsored by Jeito Capital. Reach us by sending a text