BioCentury This Week

A pair of lawmakers have dealt the Biosecure Act a setback that could derail the legislation, even as Congress continues its push to reduce reliance on China in the life sciences. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains why Sen. Rand Paul (R-Ky.) and Rep. Jamie Raskin (D-Md.) refused to sign off on inclusion of the anti-China biotech bill in the must-pass National Defense Authorization Act, what provisions the defense bill has that seek to enhance U.S. biotech supply chain resilience and whether Biosecure can be resurrected. And in the latest in neurology, Executive Editor Selina Koch discusses Novartis and PTC's $1 billion deal for the biotech’s Huntington disease therapy, and how several biotechs are poised to take therapies against the long undruggable KCC2 to the clinic for neurological disorders. Heads up: BioCentury’s JPM Guide 2025 is out now.View full story: https://www.biocentury.com/article/65442000:00 - Introduction01:42 - Biosecure Setback10:01 - Novartis' $1B PTC Deal 16:28 - KCC2 ActivationTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

On the latest BioCentury This Week podcast, Washington Editor Steve Usdin and colleagues discuss how President-elect Donald Trump’s pick to lead NIH, Jay Bhattacharya, would lead NIH and how that could affect the biopharma industry.The BioCentury team then discusses its analysis of abstracts released ahead of the American Society of Hematology (ASH) and Society for Immunotherapy of Cancer (SITC) annual conferences, highlighting methods for applying dual or bispecific CAR T cell designs to solid tumors. And they also analyze FDA approvals of products by biotech companies, noting that current trends show biotechs shedding their reliance on pharma to get drugs across the finish line for approval.View full story: https://www.biocentury.com/article/65436300:00 - Introduction01:08 - Trump's NIH Pick12:13 - Multi-targeted CAR Ts19:26 - Biotech FDA ApprovalsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Positive vibes about biotech emanating from the Jefferies Healthcare Conference were overshadowed by the uncertainty that is ahead because of the result of the U.S. elections. On the latest BioCentury This Week, BioCentury’s editors discuss how the unconventional cabinet nominations of the incoming Trump administration have cast a pall over what had been growing enthusiasm for the prospects of the biotech sector. Washington Editor Steve Usdin also discusses what the nomination of Marty Makary as the next FDA Commissioner could mean for the sector, and recaps the latest update on the Biosecure Act. The BioCentury editors also discuss which pharmas are in or out in making a challenge to Eli Lilly and Novo Nordisk in the obesity market.View full story: https://www.biocentury.com/article/65431900:00 - Introduction00:32 - Jefferies Conference Takeaways06:25 - Trump Nominations17:41 - Biosecure Act Update21:01 - Pharma in ObesityTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Giving RFK Jr. control of HHS would be disastrous, argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Expanding on his Editor’s Commentary, Usdin explains why Kennedy would be an unmitigated disaster for FDA, NIH and CMS, for biopharmas and for patients. He calls on biopharma leaders to speak out and affirm basic truths, even if it puts them in harm’s way.BioCentury’s editors also discuss why new data for GSK's Blenrep — an oncology therapy withdrawn two years ago — help make the case for introducing new therapies earlier in the course of treatment, and the recent bolus of West-East deals, including two around anti-PD-(L)1 x VEGF bispecifics: BioNTech's acquisition of Biotheus, and Merck's licensing of global rights to a LaNova asset.View full story: https://www.biocentury.com/article/65423300:00 - Introduction01:12 - RFK Jr. & HHS13:15 - Blenrep's Comback19:25 - China DealsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Trump 2.0 presents opportunities and challenges for leaders of the biopharma industry, which needs effective public policy to thrive. On the latest BioCentury This Week, BioCentury Washington Editor Steve Usdin explains what those opportunities are and lays out the potential impact on the public policy environment, which could have repercussions on FDA and beyond.BioCentury’s editors then analyze how companies, academics and advocates are pushing back on claims that they should have disclosed the results of APOE4 genotype testing to Alzheimer’s trial participants and investigations by Chinese authorities into AstraZeneca China President Leon Wang and fellow AZ employees past and current, assessing what’s known about the allegations and whether the situation could affect other MNCs operating in the country.View full story: https://www.biocentury.com/article/65415700:00 - Introduction01:01 - Prepping for Trump09:41 - Alzheimer's Ethics17:44 - AstraZeneca's Challenges in China21:51 - Myths and MisperceptionsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

It’s too soon to conclude anti-amyloid therapies are safe for use by Alzheimer’s patients in the real world, even as early reports are encouraging, argues BioCentury Executive Editor Selina Koch on the latest BioCentury This Week podcast. Koch and colleagues discuss takeaways from this year’s Clinical Trials on Alzheimer’s Disease annual meeting, including conclusions from adverse event data for Leqembi lecanemab and what the true test of appropriate use and safety for the drug might look like.BioCentury’s editors also assess Phase II data presented at CTAD by UCB that provide some of the first clues about what species of tau to target and in which patients. And they discuss what results of Tuesday’s presidential contest in the U.S. will mean for FDA, as well as the state of play for China biotech as the industry continues to grind out its first bear market.View full story: https://www.biocentury.com/article/65407500:00 - Introduction01:23 - CTAD: Anti-amyloids14:22 - CTAD: UCB's tau data19:47 - FDA & the Election28:16 - China Summit DebriefTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Twenty years of innovation in therapies targeting EGFR provides a case study in how generation of differentiated products against the target can drive market growth. On the latest BioCentury This Week podcast, BioCentury’s editors discuss EGFR as a prime example of the value in best-in-class development strategies, with meaningful improvements across multiple modalities delivering substantial therapeutic benefits to patients. Analogous best-in-class opportunities aren’t limited to cancer, but are also playing out in other settings such as immunology.The editors then discuss a recent event that hosted FDA commissioner Rob Califf and four former commissioners, all of whom agreed a major role of the FDA commissioner is to protect the agency from political interference. Washington Editor Steve Usdin also previews his conversation with FDA’s Richard Pazdur, and Editor in Chief Simone Fishburn details takeaways from her Q&A with James Sabry, who recently became CBO at BioMarin Pharmaceutical.View full story: https://www.biocentury.com/article/65392600:00 - Introduction00:38 - EGFR Case Study08:45 - FDA Commissioners & Politics19:19 - James Sabry's TimelineTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Cross-border geopolitical tensions and a prolonged capital crunch are compelling biopharma companies from Beijing to Boston to rethink their strategies on everything from deal-making and raising capital to manufacturing and use of CROs. On a special edition of the BioCentury This Week podcast, McKinsey’s Franck Le Deu and Wendy Pan of BayHelix and Goodwin join BioCentury on the eve of next week’s eleventh annual BioCentury-BayHelix China Healthcare Summit in Shanghai to discuss the dynamics affecting biotechs in China looking beyond the country’s borders and Western biopharma companies seeking innovation and partners in China, as well as the latest trends, such as U.S. VCs and/or management teams building newcos around China assets. They also detail highlights among the three-day event’s speakers, panels and fireside chats.The BioCentury-BayHelix China Healthcare Summit will take place Oct. 30 through Nov. 1 at the St. Regis Shanghai Jian in Shanghai. For information on registering to attend and/or becoming a presenting company, click here.View full story: https://www.biocentury.com/article/65395900:00 - Introduction03:32 - The View from BayHelix06:59 - The View from McKinsey18:57 - Summit HighlightsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

At least 25 venture firms have raised a total of more than $17 billion in funds this year, with Forbion unveiling the largest-ever European biopharma fund at €1.2 billion last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how Forbion deployed its prior fund and quickly raised fresh funds and what that — and other funds — say about the state of financing private biotechs in Europe and elsewhere.The editors then assess takeaways from BioCentury’s conversation with NIH’s Daniel Reich on data that could shape drug development’s future for progressive multiple sclerosis, and neurodegeneration broadly, as well as how the first clinical data from an RNA-editing oligonucleotide therapy from Wave Life Sciences demonstrate that it’s possible to change a single base in an RNA to correct a disease-causing mutation in patients.View full story: https://www.biocentury.com/article/65392400:00 - Introduction02:48 - VC Funds11:50 - New Chapter for MS23:48 - Wave's DataTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

There is a growing mandate among researchers and VCs to provide proof of causal human biology for new targets. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the different strategies being deployed to identify causal links to disease using observational patient data or human cell models, including the challenges that come with each approach and the various computational methodologies companies are using.They also discuss the outcome of FDA’s advisory committee meeting on Barth syndrome candidate elamipretide from Stealth Biotherapeutics, and the implications of the discussion for review of ultrarare disease therapies more broadly.Diving into the deal of the day, the editors review the proposal by H. Lundbeck to acquire Longboard Pharmaceuticals for $2.6 billion, and discuss how the biotech’s therapy for developmental epilepsies may stack up against competitors.View full story: https://www.biocentury.com/article/65384300:00 - Introduction00:34 - Causal Biology and Big Data17:52 - FDA's Ultra-Rare Decision27:29 - Lundbeck Acquires LongboardTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text