BioCentury This Week

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 podcasts@biocentury.com.Reach 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 podcasts@biocentury.com.Reach 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 podcasts@biocentury.com.Reach us by sending a text

Steve Usdin, the Washington editor, dives into the rare IPO filing by LB Pharma on NASDAQ, amidst a quiet biotech market. He discusses the surge of interest in Hong Kong's biotech scene, contrasting it with challenges faced in the U.S. The podcast explores the FDA's surprising reversal on Stealth BioTherapeutics' Barth syndrome treatment, emphasizing the need for innovation. Usdin also highlights the growing threats to U.S. biopharma innovation posed by potential clashes over intellectual property and regulatory practices.

Lauren Martz, Executive Director of Biopharma Intelligence, leads a discussion on the latest trends in pharmaceutical deals, revealing that bispecifics and degraders are gaining traction while cell and gene therapies are losing favor. Selena Koch, Executive Editor, shares insights from a recent conversation with Denali about advancements in brain shuttles. Karen Koch-Tusman highlights a groundbreaking FDA approval for a vector-based immunotherapy, suggesting potential new standards for treating rare diseases. Chinese biotech's growing influence is also addressed.

Franck Le Deu, a Senior Partner at McKinsey, and Ji Li, a former BD executive at major biopharmas, delve into the booming collaboration between Western and Chinese biotechs. They examine the surge in cross-border deals driven by China's maturing biotech ecosystem. The conversation reveals the Hong Kong Stock Exchange's role as a hotspot for biotech IPOs, shifting dynamics in deal-making, and the emergence of innovative companies in China. Insights on upcoming conferences and networking opportunities also highlight the future of global biopharma partnerships.

Lilly's oral obesity drug, orforglipron, sparks debate despite disappointing Phase III results, with a safety edge over injectables. Vinay Prasad’s return to the FDA prompts discussions on regulatory reform amid industry confusion. Acadia Pharmaceuticals is revamping its strategy to tackle challenges in the neurology sector. Meanwhile, the Senate aims to revive the Biosecure Act, raising concerns about fairness for biotech firms. Finally, a reimagined vision for the FDA promises innovative solutions for the future of drug regulation.

The ouster of Vinay Prasad after three months running FDA’s Center for Biologics Evaluation and Research could signal a reset is ahead for CBER. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what the latest shakeup at the regulatory agency says about what’s next for FDA.The analysts also assess two leading European pharmas: obesity and diabetes company Novo Nordisk, which named a new CEO last week while cutting its 2025 forecast, and Bayer, which is gearing up for launches and is revamping its pipeline to restart growth. Finally, they discuss the promising clinical data that’s reviving interest in masking technologies that conditionally activate biologics.View full story: https://www.biocentury.com/article/656649#FDA #CBER #NovoNordisk #ObesityDrugs #Bayer01:05 - Prasad's Ouster14:59 - Novo's New CEO21:14 - Bayer's Growth Strategy26:05 - Masked BiologicsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

A handful of encouraging signals is cause for cautious optimism for biotech headed into the second half of the year — companies have been able to parlay strong data into follow-on capital and M&A activity is picking up. That said, the IPO market continues to be closed and concerns about U.S. drug pricing and FDA stability continue to weigh on expectations for a robust near-term sector recovery.Special guest Megan Hooton from IQVIA Biotech joins BioCentury’s analysts on a special edition of the podcast to discuss key indicators of progress for the biopharma sector. Hooton is president of IQVIA Biotech, which sponsored this episode of the pod.View full story: https://www.biocentury.com/article/656614#biotech #biopharma #pharma #lifescience #BiotechTrends #ClinicalTrials #GeneTherapy #CellTherapy00:01 – Sponsor Message: IQVIA Biotech02:37 – Biotech Markets06:41 – Clinical Highlights10:26 – Insights from Meg Hooton23:10 – Advanced TherapiesTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

This week’s deal between GSK and Jiangsu Hengrui is a prime example of how Western biopharmas have begun to recognize the innovation and opportunities being fostered in China — and how it’s no longer all about fast followers.On the latest BioCentury This Week podcast, BioCentury’s analysts put the collaboration between GSK and Jiangsu Hengrui Pharmaceuticals, two of the most active cross-border dealmakers, into the context of East-West dealmaking over the past 30 months, assessing the innovation that is driving the rush to partner with biotechs in China, Japan, South Korea and beyond, and the types of companies looking to Asia for assets.BioCentury’s analysts also discuss Steve Bates’ outsized role in building the U.K. biotech hub, as he readies to take on a new role in the U.K. government. They examine new VC funds from Omega Funds and Brandon Capital, FDA’s new national priority voucher pilot program, and fallout from how FDA and  Sarepta Therapeutics handled the deaths of four patients who had received the biotech’s gene therapies. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656592#biotech #biopharma #pharma #lifescience #EastWestDealmaking #ChinaBiotech #UKBiotech #FDAPolicy00:01 - Sponsor Message: IQVIA Biotech02:48 - Asia Deals Landscape17:32 - Steve Bates & U.K. Biotech25:46 - FDA's New Voucher Pilot31:01 - New VC Funds35:28 - SareptaTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text