Ep. 328 - Brain Shuttles, GSK Q&A and FDA Vouchers

Next-generation platforms and technologies are getting closer to cracking one of biopharma’s biggest problems: delivering medicines, and mAbs in particular, to the brain. On the latest BioCentury This Week podcast, BioCentury’s Selina Koch details the latest innovations in blood-brain-barrier shuttles and how the technologies could transform the treatment of neurological diseases.BioCentury’s Lauren Martz discusses her conversation with Tony Wood, CSO of GSK, which included the pharma’s strategy for indication expansion, why it prefers RNA modalities over AAV-based gene therapies, and how its quest for causal biology has evolved over the years.Washington Editor Steve Usdin discusses the first set of FDA’s new commissioner’s national priority review vouchers, and why the voucher program is unlikely to function as an incentive capable of steering future behavior. Usdin also discusses the potential impact of FDA staffing reductions on the sector. This episode of BioCentury This Week is sponsored by Evotec.View full story: https://www.biocentury.com/article/657326#BloodBrainBarrier #Neurology #DrugDelivery #MonoclonalAntibodies #RNAtherapeutics #CausalBiology #FDA00:01 - Sponsor Message: Evotec01:57 - Brain Shuttles13:57 - GSK Q&A20:08 - FDA VouchersTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Biotech’s fourth quarter began with a familiar feeling, with indicators pointing toward an improving public market even as political and regulatory uncertainty has buysiders reluctant to say industry has returned to sustainable growth. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the state of biotech’s public markets. The analysts discuss the Senate’s move to limit access to Chinese CDMOs, the latest developments in the White House’s “most favored nation” drug pricing negotiations, and the U.K.'s attempt to win over pharma companies via adjusting thresholds at NICE. Finally, they analyze a pair of billion-dollar-plus M&A deals: the $4.7 billion deal by Novo Nordisk to acquire liver disease company Akero and the $1.5 billion takeout of in vivo cell therapy company Orbital by Bristol Myers. This episode of BioCentury This Week is sponsored by Evotec.View full story: https://www.biocentury.com/article/657260#biotech #biopharma #pharma #lifescience #drugpricing #MFN00:01  Sponsor Message: Evotec02:12  4Q Markets Preview13:25  China CDMOs24:35  Drug Pricing Deals NHS31:22  Drug Pricing Deals M&ATo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

The short-term consequences for Pfizer from its “most favored nation” drug pricing deal with the White House are negligible, but the long-term effects on the industry could be profound and permanent. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses why the deal by Pfizer Inc. (NYSE:PFE) changes everything — and nothing — and what’s next in wrangling over drug pricing between industry and the Trump administration. The analysts also discuss PDUFA negotiations between FDA and leaders of BIO and PhRMA, how multi-site IITs could help bridge the academia-industry gap, and how TCG X plans to deploy its new $1.3 billion fund. This episode of BioCentury This Week is sponsored by Evotec.View full story: https://www.biocentury.com/article/657192#biotech #biopharma #pharma #lifescience #financialmarkets #drugpricing #MFN00:01  Sponsor Message: Evotec03:31  Pfizer MFN Deal16:05  PDUFA Reauthorization20:31  Investigator-Initiated TrialsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Genmab's $8 billion acquisition of multispecifics company Merus is the Danish biotech’s largest step toward marketing its own pipeline. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the evolution of Genmab, which, for many years, relied on a partnership model that delivered blockbuster revenues but now is making a change as a patent cliff looms.The analysts also assess the tenure of Emma Walmsley the longtime CEO of GSK, and what’s next for the U.K. pharma under incoming CEO Luke Miels. Turning to the U.S., Washington Editor Steve Usdin discusses President Donald Trump’s looming tariff threat on imports of branded drugs, which Usdin says would hurt small biotechs the most. Usdin also analyzes the response of multinational pharmaceutical companies to the president’s demand that they make “most favored nation” price concessions, now that Monday’s deadline has passed. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/657131#biotech #pharma #deals #FGF21 #MASH #Interleukin5 #asthma #PhRMA #PBM #tarriff #MFN00:01 - Sponsor Message: IQVIA Biotech02:26 - Genmab's Merus Buy09:43 - CEO Switch at GSK17:22 - Trump Tariff Threat21:17 - MFN Drug PricingTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

AI is bringing sweeping changes to drug development, from how targets are discovered to optimizing clinical trials to maximize an asset’s chance for success. On a special edition of the BioCentury This Week podcast, IQVIA’s Greg Lever joins BioCentury’s analysts to discuss agentic AI’s short- and long-term prospects to help biotechs discover new targets, predict success in preclinical development, and enhance clinical operations. This episode of BioCentury This Week is sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/657086#Biotech #Biopharma #DrugDevelopment #ClinicalTrials #TargetDiscovery #AgenticAI #GraphRAG #DeRisking00:01 - Sponsor Message: IQVIA Biotech01:22 - AI in Biotech05:01 - Machine Learning06:21 - Generative AI and Language Models08:37 - Agentic AI12:43 - AI in Target Discovery23:44 - AI in Clinical Trial DesignTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Is this the U.K.’s moment to capitalize on its biotech ecosystem? That was one of the primary themes discussed at the debut Grand Rounds — Europe conference last week in Cambridge, U.K. BioMarin's James Sabry and Astex's Michelle Jones joined BioCentury’s analysts on a special edition of the BioCentury This Week podcast recorded live at the event to discuss their key takeaways from the two-day conference.Beyond the state of the U.K. biopharma ecosystem, the analysts discussed the meeting’s major science themes, including what’s next for DNA damage repair pathway targets, both inside and outside of cancer; whether obesity should be recast as a brain disease; and the cutting edge of small molecule design.View full story: https://www.biocentury.com/article/657082#UKBiotech #TranslationalMedicine #DrugPricing #GlobalCollaboration #Aging #Biologics #SmallMolecules #Biobanking00:00 - Introduction00:35 - Key Takeaways02:14 - The State of the U.K. Biotech Ecosystem09:01 - Scientific Highlights & Panel Takeaways22:44 - Closing Remarks and Future EventsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

A takeout that could be worth as much as $7.3 billion has Pfizer back in the obesity drug development race. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Pfizer’s acquisition of Metsera and its obesity assets. Plus: Editor in Chief Simone Fishburn gives a recap of BioCentury’s Grand Rounds — Europe meeting, which included a fireside chat with Patrick Vallance on the state of the life sciences ecosystem in the country. The BioCentury analysts also assess the state of hot-button policy issues in Washington, such as drug pricing and China. Finally, they analyze the state of play among therapies for narcolepsy on the heels of the World Sleep Congress in Singapore. Check out BIO Chairman Fritz Bittenbender’s conversation with BioCentury Washington Editor Steve Usdin on BioCentury This Week’s sister podcast, The BioCentury Show. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/657065 #ObesityDrugs #PharmaDeals #BiotechDeals #MergersAndAcquisitions #DrugDevelopment #Narcolepsy00:01 - Sponsor Message: IQVIA Biotech03:46 - Pfizer’s Obesity M&A14:54 - U.K. in Focus28:20 - U.S. Drug Pricing, China Policy40:07 - Narcolepsy PipelineTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Merck's announcement that it is moving its R&D out of the U.K. highlights concerns about the country’s life sciences policies. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the life sciences ecosystem in the U.K., including MHRA CEO Lawrence Tallon’s plans to create a world-class regulatory environment. They also discuss a bill passed by the U.S. House of Representatives that would end most U.S.-China academic research collaborations, and the recent success of 40-year-old biotech Insmed. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656997#biotech #biopharma #pharma #lifescience #MHRA #China #RandD #DrugDevelopment00:01 - Sponsor Message: IQVIA Biotech01:25 - U.K. Biopharma04:40 - Grand Rounds Cambridge09:45 - SAFE Research Act18:01 - Spotlight on Insmed26:32 - Sen. Cassidy's Vaccine CalloutTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Molecular biologist and Nobel Prize winner David Baltimore made foundational contributions to the biopharma industry and was the essential figure behind such research institutions as the Whitehead Institute for Biomedical Research and the Broad Institute. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the legacy of Baltimore, who passed away this past weekend at 87.The analysts also discuss Atlas Venture’s new $400 million opportunity fund, the clinical development pipelines for metabolic-associated steatohepatitis (MASH) and chronic urticaria, and late-stage atopic dermatitis data from Sanofi. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656942#biotech #biopharma #DavidBaltimore #ReverseTranscriptase #MASH #Rezdiffra #GLP1 #ChronicUrticaria #Dupixent00:01 - Sponsor Message: IQVIA Biotech03:19 - Remembering David Baltimore06:26 - Atlas's New Opportunity Fund09:22 - The Growing MASH Pipeline16:03 - Sanofi's Atopic Dermatitis Data18:57 - Exploring Chronic Urticaria TreatmentsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Two veteran biotech leaders are launching a new company with ambitions in the cardiovascular disease space. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the debut of Corsera Health, a biotech led by John Maraganore and Clive Meanwell that is developing an AI-guided early risk assessment tool alongside dual-acting therapy that could stave off heart disease.The team then discusses how FDA has been quietly positioning itself to disrupt the childhood vaccine schedule, as well as the effects of changes to the Medicare drug negotiation program that were included in the tax and budget bill Congress passed in July.View full story: https://www.biocentury.com/article/656897#Corsera #DiseaseInterception #CardiovascularHealth #HeartDisease #FDA #VaccinePolicy #Medicare #DrugPricing00:00 - Introduction01:26 - Maraganore, Meanwell Newco09:17 - BioCentury's Back to School14:51 - Vaccine Disruption at FDA26:01 - Medicare Drug NegotiationsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text