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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.
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.
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.
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.
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.
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.
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.
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.
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.
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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