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BioCentury This Week

BioCentury

BioCentury's streaming commentary on biotech industry trends, plus interviews with KOLs.

For three decades, BioCentury has helped biopharma executives and investors make business-critical decisions and build larger networks with peers across the innovation ecosystem.

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S7 · E397
Tuesday · 28 min
Ep. 397 - What the U.S. midterms mean for biopharma
Midterm election results in the U.S. have short-circuited plans to install a Senate-confirmed FDA commissioner and could open a narrow path to bipartisan drug pricing legislation. On the latest BioCentury This Week podcast, BioCentury’s analysts assess what the results mean for FDA and HHS leadership, user fee negotiations, vaccine regulation, and the prospect of applying most-favored nation pricing to Medicare drug price negotiation. The analysts also unpack full Phase III data showing pelacarsen failed across all subgroups and what it means for Lp(a) as a cardio target, highlight SITC abstracts on localizing immunotherapy within solid tumors, and discuss argenx’s $550 million upfront buyout of Unnatural Products. This episode of the BioCentury This Week podcast has been brought to you by Tigermed. View full story: https://www.biocentury.com/article/661519 #BiotechPolicy #FDA #DrugPricing #Cardiovascular #Immunotherapy 0:01 Sponsor Message: Tigermed 5:06 FDA Leadership After Midterms 12:41 HHS and Drug Pricing 17:34 Pelacarsen Readout at AHA 22:31 SITC Abstract Highlights 25:57 argenx’s Peptide Deal To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E396
November 7 · 29 min
Ep. 396 - China’s first-order innovation
Rising first-in-class innovation, faster IND reviews and deep patient pools are drawing global biotechs to China, even as U.S. outbound investment restrictions loom. In a special edition of the BioCentury This Week podcast recorded live at the 13th BioCentury-BayHelix China Healthcare Summit in Shanghai, BioCentury’s Jeff Cranmer, Simone Fishburn and Josh Berlin are joined by Kali Therapeutics CEO Weihao Xu, Charles River’s Matthew Hewitt and Aerska CEO Jack O’Meara to discuss key themes from the event. The panel assesses what the COINS Act could mean for U.S. investment in China biotech and how investors may adapt, how China’s 30-day IND review and new investigator-initiated trial rules are reshaping clinical strategy, and what dealmaking reveals about the country’s growing first-in-class pipeline. They also preview BioCentury’s East-West Summit in Seoul, March 15-17. View full story: https://www.biocentury.com/article/661483 #ChinaBiotech #COINSAct #ClinicalTrials #FirstInClass #BiotechPartnering 0:00 Live from China Healthcare Summit 5:20 China's Role in Biotech R&D 9:06 What COINS Could Mean for U.S. Investors 11:37 Faster IND Reviews and New IIT Rules 17:27 First-Order Innovation in China To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E395
November 3 · 33 min
Ep. 395 - ESMO analysis & Auchincloss proposal
A BioCentury analysis of ESMO first-in-human abstracts finds antibody-drug conjugates outnumbering every other modality, even as payload innovation lags behind target innovation. On the latest BioCentury This Week podcast, BioCentury's analysts discuss why new targets alone may not be enough to overcome resistance. Turning to policy, the analysts examine Representative Jake Auchincloss’ Faster Clinical Trials Act, which would embed trials in routine care and expand the NIH's All of Us biobank. They also discuss how U.S. investors are reacting to Treasury's proposed COINS Act rule, including a workaround that pays Chinese licensors on exit instead of with equity, and former FDA Commissioner Janet Woodcock's proposals to make individualized rare disease therapies commercially viable. View full story: https://www.biocentury.com/article/661405 #ADCs #ClinicalTrials #BiotechPolicy #ChinaBiotech #RareDisease 0:00 Introduction 1:34 ESMO First-in-Human Analysis 10:26 Faster Clinical Trials Act 19:27 COINS Act and NewCos 28:19 Woodcock's Rare Disease Proposals 31:53 Biotech IPO Debuts To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E394
October 27 · 33 min
Ep. 394 - Security concerns in U.S., China reshaping biotech
Proposed U.S. Treasury rules implementing the COINS Act would bar U.S. equity investments, joint ventures and co-development deals with China biotechs, potentially ensnaring Asia-to-West NewCos while leaving licensing intact. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the rule’s implications for cross-border dealmaking, the competitive opening it may create for European companies, and China’s narrower-than-feared draft export controls on platform technologies. The analysts also discuss what drew Gilead to pay $1.3 billion up front for stealth Shanghai biotech PepStar’s oral IL-23 peptide, and whether Merck and Moderna’s Phase III melanoma vaccine data clear the bar for adoption. View full story: https://www.biocentury.com/article/661319 #BiotechPolicy #ChinaBiotech #CrossBorderDeals #NewCos #CancerVaccines 00:00 Introduction 01:31 Treasury's COINS Act Proposal 05:15 NewCos Under COINS 13:20 China's Draft Export Controls 18:39 Pepstar's Gilead Deal 23:24 Merck-Moderna Melanoma Vaccine To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E393
October 20 · 30 min
Ep. 393 - China trends; Roche, Merck KGaA deals; Arrowhead & tau
Roche’s $15 billion biobucks deal with Hansoh for preclinical ADCs is the latest in a string of China licensing deals carrying unusually large upfronts for early-stage assets. On the latest BioCentury This Week podcast, BioCentury’s analysts assess trends to watch ahead of Shanghai Life Sciences Week, including how new rules have curtailed China’s IIT pathway and a proposed export-control regime that could complicate cell and gene therapy and siRNA deals. The analysts also discuss Merck KGaA’s $1.3 billion takeout of Silence, Arrowhead’s brain-shuttle tau data and the dose dilemma facing tau-lowering therapies, and whether a preclinical biotech like Isomorphic Labs can justify a $40-50 billion valuation. View full story: https://www.biocentury.com/article/661224 #ChinaBiotech #siRNA #BiotechMA #DrugDiscovery #DrugDevelopment 0:00 Introduction 1:13 China Trends 9:00 Roche-Hansoh Deal 13:11 Merck KGaA Buys Silence 15:38 Arrowhead's Brain Shuttle 23:40 Isomorphic Labs Valuation To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E392
October 13 · 24 min
Ep. 392 - Biotech markets: Pause before the storm?
An M&A-fueled first half gave way to third-quarter underperformance for biotech as a short squeeze in Moderna forced specialist funds into selling some quality names and follow-on activity slowed. On the latest BioCentury This Week podcast, BioCentury’s analysts preview the fourth quarter, where rising bond yields and the U.S. midterms could keep financing and deal activity quiet through year-end. The analysts also discuss why late-stage misses in Lp(a), IL-6, and Factor XI are pushing developers to rethink secondary prevention trial design, and PhRMA’s lawsuit to block CMS’s Globe Part B model, which could determine whether future administrations can impose international reference pricing without Congress. View full story: https://www.biocentury.com/article/661134 #BiotechMarkets #DrugPricing #CardiovascularDisease #ClinicalTrials #FDA 0:00 Introduction 1:10 Biotech Market Outlook 11:40 CV Trial Design Rethink 18:24 PhRMA vs. GLOBE To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E391
October 6 · 30 min
Ep. 391 - China deals, Beam lawsuit, MFN models, Nobel winners
Pharma partnering in China is getting earlier and broader, with Merck & Co., Novo Nordisk and Novartis striking multibillion-dollar deals for assets spanning new modalities and disease areas. On the latest BioCentury This Week podcast, BioCentury's analysts assess the trend and why co-development deals could draw scrutiny in Washington. The analysts also discuss the complexities of Beam's trade secret suit against YolTech, why the GLOBE Medicare pricing model matters more for the precedent it sets than for its savings, and the Nobel Prize for optogenetics as the first therapy based on the technology nears an FDA decision. View full story: https://www.biocentury.com/article/661028 #ChinaBiotech #DrugPricing #IntellectualProperty #DrugDevelopment #NobelPrize 0:00 Introduction 1:30 China Pharma Deal Trends 11:29 Beam vs. YolTech Lawsuit 20:01 Small GLOBE, Big Precedent 24:05 Nobel Prize & Optogenetics To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E390
September 30 · 34 min
Ep. 390 - Live from Amsterdam: Grand Rounds Europe takeaways
Mechanisms broad enough to matter across many diseases, from mitochondrial health to the biology of aging, emerged as a defining theme at Grand Rounds Europe in Amsterdam. On a special live edition of the BioCentury This Week podcast, BioGeneration Ventures' Oskar Slotboom, NautaDutilh's Ruud Smits and Leyden Labs' Dinko Valerio join BioCentury's analysts to discuss women's health and sleep as lenses on disease, and the shift toward prevention. The panel also weighs the limits of "Frankenstein" multiparatopic molecules and AI-driven discovery, knowledge gaps in autonomous labs, new China first-in-human rules, and what Novartis' Lp(a) miss means for genetically validated targets. View full story: https://www.biocentury.com/article/660970 #EuropeBiotech #DrugDiscovery #TranslationalMedicine #GeneticTargets #HealthSpan 0:00 Introduction 2:10 Bridging Academia & Industry 14:51 Key Themes 26:02 Toolbox and Biology 31:05 Lp(a) Fallout & Genetic Targets To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E389
September 29 · 37 min
Ep. 389 - IgA nephropathy, Overton hearing, reverse mergers' new look
Seven global approvals in five years, validated biomarkers and FDA flexibility have turned IgA nephropathy from a neglected rare disease into a crowded field, with Biogen, Novartis, Takeda, Climb Bio and Jade chasing targets such as APRIL, BAFF and CD38. On the latest BioCentury This Week podcast, BioCentury's analysts assess how next-generation therapies are competing on safety and longer dosing intervals. The analysts also discuss Heidi Overton's FDA commissioner confirmation hearing and lingering questions about her independence, new pharma tariff guidance that leaves exemptions unclear, and how reverse mergers paired with nine-figure PIPEs became a viable IPO alternative. Plus, Merck's $400 million upfront bet on a preclinical KRAS G12C molecular glue. View full story: https://www.biocentury.com/article/660935 #IgANephropathy #FDA #BiotechIPO #DrugDevelopment #ClinicalTrials 0:00 Introduction 1:30 Grand Rounds: Europe Recap 6:03 IgA Nephropathy Pipeline 14:57 Overton Hearing 22:19 Commerce's Tariff Guidance 24:28 Reverse Mergers' New Look To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E388
September 22 · 32 min
Ep. 388 - Biotech IPOs, CAR T safety & pharma tariffs
The first biotech IPO in a month, Electra's upsized $350 million offering, fell in its trading debut, testing investor appetite while a wave of reverse mergers showcases an alternate route to NASDAQ. On the latest BioCentury This Week podcast, BioCentury's analysts examine momentum in the biotech IPO market. The team also unpacks fatal toxicities in Novartis' autoimmune CAR-T trials and what they reveal about manufacturing, dosing and immune biology risks across the modality. In Washington, Steve Usdin previews Heidi Overton's FDA Commissioner confirmation hearing and reports on the persistent uncertainty around pharma tariffs ahead of the Sept. 29 deadline. View full story: https://www.biocentury.com/article/660870 #BiotechIPO #CARTCell #FDA #PharmaTariffs #DrugDevelopment 0:00 Introduction 02:15 Biotech IPO Market 10:38 Autoimmune CAR-T Safety 21:56 FDA Commissioner Hearing 26:47 Pharma Tariff Uncertainty To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E387
September 15 · 30 min
Ep. 387 - Psychedelics at FDA, Mike Davis’ CDER & tRNAs
Note: This episode was briefly published with an incorrect audio file, which has since been corrected. FDA is prepared to approve psychedelic therapies for chronic psychiatric disorders before sponsors have fully determined how long the effects last or when patients should receive second or subsequent doses. On the latest BioCentury This Week podcast, BioCentury's analysts assess the latest guidance on psychedelics from FDA. The team also discusses takeaways from Michael Davis' first interview as CDER director, plus preclinical advances positioning suppressor tRNA for Duchenne, cystic fibrosis, and other nonsense-mutation diseases. They also highlight Emerging Company Profiles on BrainChild and Cloverleaf. View full story: https://www.biocentury.com/article/660792 #Psychedelics #FDA #GeneTherapy #ClinicalTrials #DrugDevelopment 0:00 - Introduction 1:13 - Psychedelics at FDA 10:20 - Mike Davis Leads CDER 22:29 - Suppressor tRNAs Advance To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E386
September 9 · 35 min
Ep. 386 - Novartis misses, pharma deals analysis, MFN carve-outs
A pair of high profile clinical setbacks has wiped out more than $40 billion in market cap for Novartis, most of which stemmed from the Phase III miss of antisense oligonucleotide therapy pelacarsen. On the latest BioCentury This Week podcast, BioCentury's analysts unpack the fallout for Lp(a) as a cardio target and whether issues with the target, modality or treatment setting contributed to the therapy's lack of efficacy. The analysts also review BioCentury's annual big pharma deals analysis, which found industry's largest players leaning into disruptive platforms such as bispecifics, in vivo CAR Ts, siRNAs, and degraders. In Washington, Steve Usdin reports on most-favored nation drug pricing carve-outs and policy pressure on mid-tier biotechs – plus the conspicuous lack of U.S. biotechs coming to the table -- pays tribute to the late Peter Barton Hutt, the former FDA Chief Counsel who shaped foundational elements of modern FDA law. View full story: https://www.biocentury.com/article/660746 #CardiovascularDisease #DrugPricing #BiotechMA #ClinicalTrials #FDA 0:00 - Introduction 1:23 - Novartis Phase III Fallout 18:24 - Annual Pharma Deals Analysis 27:42 - MFN Carve-Outs 32:39 - Remembering Peter Barton Hutt To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E385
September 1 · 35 min
Ep. 385 - MFN deals, Lilly takeout, FDA pick Overton
Mid-sized biopharma companies are under growing pressure to accept most-favored nation drug pricing deals with the White House. On the latest BioCentury This Week podcast, BioCentury's analysts assess the trade-offs companies face, the litigation risks around mandatory Medicare MFN pricing demonstrations, and what happens to companies that don't sign on. The analysts also discuss Eli Lilly's acquisition of Merida, its thirteenth takeout of the year, Heidi Overton's nomination as FDA commissioner and what it signals about FDA independence, and Revolution Medicines' 35-day filing-to-approval timeline under FDA's national priority review voucher pilot. View full story: https://www.biocentury.com/article/660655 #DrugPricing #FDA #BiotechMA #Oncology #BiopharmaPolicy 0:00 - Introduction 2:14 - MFN Drug Pricing Deals 10:09 - Lilly Acquires Merida 22:22 - FDA Commissioner Pick 30:11 - RevMed's Rapid Approval To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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August 28 · 42 min
Ep. 384 - Back to School Special: The global FIH trials race
China has changed the global narrative on delivering early human clinical data, with a new bar for speed and efficiency. And now drug developers and policymakers around the world have gotten the message and know that this is no time for complacency. On a special edition of the BioCentury This Week podcast, BioCentury's analysts discuss why transformational reform for early clinical development will require rethinking the risk-control paradigm for first-in-human trials. It’s the subject of the 2026 Back to School issue, the 34th edition of an annual analysis that takes on one of the most pressing topics facing the biopharma industry. View full story: https://www.biocentury.com/article/660629 #ClinicalTrials #FirstInHuman #DrugDevelopment #FDA #BiopharmaPolicy 0:00 - Introduction 6:40 - U.S. 15:09 - Australia 24:00 - China 32:14 - Europe To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E383
August 25 · 19 min
Ep. 383 - Moderna, Genentech obesity deal, Trump's FDA pick
A Phase III win for a melanoma vaccine from Moderna and Merck & Co. has opened the door to personalized neoantigen vaccines. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the vaccine’s prospects and the broader implications. The analysts also discuss Roche/Genentech’s deal with Hanmi, which will add to the MNC’s obesity pipeline an asset that the pharma believes could be first in class, and the White House's pick of a Trump loyalist to lead FDA – a move that has revived questions of the agency's independence. View full story: https://www.biocentury.com/article/660596 #CancerVaccines #Obesity #FDA #Oncology #DrugDevelopment 00:00 - Introduction 03:03 - Moderna 11:12 - Genentech obesity deal 15:08 - Trump's FDA pick To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E382
August 18 · 25 min
Ep. 382 - Summer’s venture wave; drugging beta-catenin; Capricor & FDA
A baker’s dozen of biotechs shrugged off the summer haze to raise nearly $800 million in venture cash. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the financings, which included money for a potential challenger to Amgen’s blockbuster Tepezza and a new venture from immunology professor Georg Schett with backing from Deerfield Management, Boulevard Bio. The analysts also discuss new approaches to drug cancer’s “undruggable” β-catenin pathway, and whether Capricor’s latest regulatory move will give Duchenne muscular dystrophy therapy deramiocel new life at FDA. View full story: https://www.biocentury.com/article/660539 #BiotechFinancing #DrugDevelopment #BetaCatenin #DuchenneMuscularDystrophy #Biopharma 00:00 - Introduction 02:18 - Venture Rounds 12:02 - Drugging β-catenin 18:12 - Capricor & FDA To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E381
August 11 · 31 min
Ep. 381 - FIH urgency in the U.S. Plus: federated learning, biotech IPOs
Pressure is on FDA, policymakers and academic centers in the U.S. to respond to challenges from China, Australia, and beyond to run first in human trials faster and more efficiently. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how stakeholders in the U.S. are responding to the challenge. The analysts also discuss the next frontiers of federated learning in drug discovery and the latest crop of biotech IPOs on NASDAQ, which raised over $1.2B in strong IPO run last week. View full story: https://www.biocentury.com/article/660433 #ClinicalTrials #BiopharmaPolicy #DrugDevelopment #BiotechIPO #FederatedLearning 00:00- Introduction 01:15 - Academic Centers 10:42 - Policy Picture 15:48 - Grand Rounds Europe Highlights 18:01 - Federated Learning 28:15 - NASDAQ IPOs To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E380
August 4 · 32 min
Ep. 380 - AZ-BMS rumors, Replimune, psychedelics
Rumors flew this weekend about a mega-merger of AstraZeneca and Bristol Myers — but would such a deal make sense? On the latest BioCentury This Week podcast, BioCentury’s analysts explain why they aren’t buying it. The team also discusses what lessons can be learned from the regulatory roller-coaster ride of Replimune’s RP1 vusolimogene oderparepvec and psychedelic therapies’ inflection point in treating depression. View full story: https://www.biocentury.com/article/660376 #BiotechMA #FDA #Psychedelics #Depression #OncolyticVirus 00:00 - Introduction 00:51 - AZ-BMS Rumors 08:07 - Replimune 20:46 - Psychedelics To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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S7 · E379
July 28 · 34 min
Ep. 379 - Argenx M&A, AI giants and biopharma, catalyst scorecard
Argenx the tier-jumping European biotech, believes its proposed $2.2 billion purchase of Forte Biosciences will add a second multi-indication product upon which it can run the strategy that has made autoimmune drug Vyvgart efgartigimod alfa a blockbuster. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the deal and put it in the context of a new cohort of large-cap companies increasingly active in biotech M&A. The analysts also assess how recent releases from Anthropic, NVIDIA, Google, OpenAI and Amazon fit into biopharma R&D workflows — and with one another. Finally, they analyze the 1H26 clinical and regulatory catalyst scorecard, which therapies hit their milestones, which missed, and what’s next through year-end. This episode of the BioCentury This Week podcast has been brought to you by CBRE. View full story: https://www.biocentury.com/article/660296 #BiotechMA #ArtificialIntelligence #DrugDevelopment #ClinicalTrials #Biopharma 00:01 - Sponsor Message: CBRE 01:57 - BioCentury AI Connector 05:47 - Argenx Acquires Forte 08:06 - Rise of Biotech Buyers 13:12 - AI Giants' Tech Stack 24:20 - Anthropic Enters Drug Development 27:41 - 2026 Catalyst To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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July 21 · 42 min
Ep. 378 - U.K. cabinet shuffle, Taiwan biotech and Biogen data
The departure of U.K. Science Minister Patrick Vallance is a blow for U.K. biotech. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what Vallance’s exit, the appointment of John Healey as Chancellor of the Exchequer and other changes arriving with the new Prime Minister could mean for life sciences in the country. BioCentury’s analysts also discuss an ambitious U.K. data initiative launched this month. The Health Data Research Service is intended to be a single front door to all NHS health records, offering large-scale longitudinal health data across diverse populations. Beyond the U.K., the team turns to companies to watch in Taiwan, what’s next for Biogen’s anti-tau therapy, Eli Lilly’s proposed acquisition of psychedelics company AtaiBeckley, and the latest changes at FDA. This episode of the BioCentury This Week podcast has been brought to you by CBRE. View full story: https://www.biocentury.com/article/660194 #Biotech #LifeSciences #UKBiotech #HealthData #FDA 00:01 - Sponsor Message: CBRE 02:23 - U.K. Leadership Changes 09:21 - U.K. Data Initiative 10:52 - Taiwan Biotech 16:44 - Biogen’s Tau Data 27:18 - Lilly’s Psychedelics Takeout 28:20 - FDA To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text
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