BioCentury This Week

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

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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

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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

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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

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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

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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

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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

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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

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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

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