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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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text

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 [email protected]. Reach us by sending a text