BioCentury This Week

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

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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.
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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.
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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.
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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.
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