Ep. 278 - Trump 2.0’s Impact on FDA, NIH. Plus: Precision Medicine

Biotech indexes are tumbling after one of FDA’s last veteran leaders was pushed out by HHS Secretary RFK Jr. and the threat of tariffs weigh on a key biotech index. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the factors driving down the XBI, which has now crossed into bear market territory and the latest turmoil at FDA, now that CBER Director Peter Marks has been ousted. Plus, inflammation and immunology companies are finding ways beyond precision medicine to boost responses. BioCentury’s editors assess one approach — bispecific antibodies that block two inflammatory pathways instead of one.View full story: https://www.biocentury.com/article/65548800:00 - Introduction00:51 - XBI's Return to the Bear Market11:26 - Marks Ouster & Turmoil at FDA18:07 - Bispecifics for I&ITo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

European venture firm Sofinnova Partners is expanding the reach of its Biovelocita accelerator beyond Italy to stretch across the greater continent. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how Biovelocita became the largest life sciences accelerator in Europe. The editors also discuss Novo Nordisk's latest addition to its obesity pipeline via a deal in China, and how the partnership reflects the state of cross-border dealmaking more broadly. And Washington Editor Steve Usdin assesses President Trump’s threat to impose 25% tariffs on pharmaceutical imports and provides an update on how FDA’s staff is navigating the policies of the new administration. Finally, Editor in Chief Simone Fishburn discusses BioCentury's upcoming Grand Rounds meetings.View full story: https://www.biocentury.com/article/65543800:00 - Introduction02:25 - Sofinnova’s Pan-European Accelerator08:27 - China Biotechs14:59 - Trump TariffsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

BIO is engaging with President Donald Trump to protect and improve FDA. It’s also hoping biopharmas can dodge tariffs and find paths to modify the Inflation Reduction Act and reinstate pediatric priority review vouchers. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin delivers takeaways from his conversation with John Crowley, CEO of the industry trade group.BioCentury’s editors also discuss how autoimmune CAR T companies are competing for resources and the end-to-end radiopharma ambitions of Telix Pharmaceuticals. A 2023 landscape on the radiopharma space can be found here.View full story: https://www.biocentury.com/article/65537000:00 - Introduction02:09 - BIO's Trump 2.0 Plan14:00 - Autoimmune CAR Ts21:05 - Telix's Radiopharma PlayTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

While the culling of companies in the biotech bear market may have yet to subside, creative cross-border deal-making on innovative assets is spreading across Asia’s Arc of Innovation. Sciwind Biosciences Co. Ltd.’s Jing Shu and A*Star’s Lisa Ooi join BioCentury to wrap up the 4th annual BioCentury-BayHelix East-West Biopharma Summit in Singapore by discussing deal-making trends, the rise of new technologies and the deepening of biotech ecosystems from India to Japan.View full story: https://www.biocentury.com/article/65531800:00 - Introduction01:58 - Key Takeaways08:42 - Innovation in Japan and India12:54 - Building Biotech Ecosystems31:14 - NewCo ModelTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

The almost certain confirmation of Marty Makary as FDA commissioner this month will cap a transition marked by internal upheaval and political infighting. On the latest BioCentury This Week podcast, BioCentury’s editors discuss Thursday’s confirmation hearing for President Donald Trump’s pick to lead the agency and Makary's hints at what we can expect from his agenda.The editors also discuss whether the advantages of amylin agonists could help the therapies outshine GLP-1 in obesity, why the latest weight loss data from CagriSema weighed on shares of Novo Nordisk, and a call to deliver on the meritocracy ideal, now that DEI is dead.View full story: https://www.biocentury.com/article/65530200:00 - Introduction01:10 - Makary’s FDA Agenda10:50 - Amylin in Obesity24:21 - Life After DEITo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

The track record of biotechs launched to create curative therapies using CRISPR-Cas9 provides new insights into the old debate over whether platform companies should validate their technology on established targets or pursue new ones. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the lessons learned by this small group of companies since their launch a decade ago. They also discuss the entrance of AbbVie into the obesity race via a $350 million deal with Gubra for a clinical stage amylin agonist — does it signal AbbVie’s belief in amylin monotherapy, or will the company be hunting for more obesity assets? The editors also talk about recommendations to streamline the early-stage development of rare disease therapies in the U.S.View full story: https://www.biocentury.com/article/65521400:00 - Introduction00:36 - CRISPR Companies09:22 - AbbVie Enters Obesity Race17:19 - Rare Disease Drug ChallengesTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Once pharma’s oncology powerhouse, Roche is charting a new course that extends beyond its traditional stronghold in cancer therapeutics. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the Swiss pharma has reshaped its strategy for long-term growth. They also discuss another tumultuous weekend for staff at FDA and NIH, as well as the challenges of precision medicine for psychiatric conditions.View full story: https://www.biocentury.com/article/65515700:00 - Introduction00:45 - Roche Reboot08:47 - Precision Medicine in Psychiatry13:07 - 5 Things on Trump 2.0To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Rather than fretting over increasing competition from Chinese life sciences companies, biotechs in the U.S. should rise to the challenge and learn from their competitors. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the increasing pace of innovation from China and how U.S. biotechs need to meet the moment, delivering key takeaways from Editor in Chief Simone Fishburn’s fireside chat with industry leader John Maraganore at the BIO CEO & Investor Forum in New York last week. The team also discusses the fallout from staffing cuts at FDA — severely damaged morale among remaining staff and the potential for a higher approval bar, among others — leadership at the agency and the state of biotech IPOs on NASDAQ and in Korea.View full story: https://www.biocentury.com/article/65511200:00 - Introduction00:58 - Competing with China14:13 - FDA, NIH Staff Cuts20:16 - Biotech IPOs To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Western VCs are paying more attention than ever to innovation emerging from Asia — from antibody-drug conjugates to bispecifics, AI and beyond — as the NewCo Model becomes the latest trend to bridge talent, assets and venture money across the Pacific and on to North America and Europe. On a special edition of BioCentury This Week podcast, a trio of leaders from Asia’s life sciences ecosystem — Khoo Shih of Singaporean investor ClavystBio, McKinsey & Company’s Anirudh Roy Popli and Wendy Pan of Goodwin and BayHelix — join the BioCentury team to set the stage for the fourth BioCentury-BayHelix East-West Biopharma Summit. They discuss the innovations driving the deal flow from East to West, including the creation of start-ups in the West formed around assets from Asia. The summit takes place March 3-5 in Singapore.View full story: https://www.biocentury.com/article/65510800:00 - Introduction04:49 - The Newco Model and Industry Trends09:13 - BayHelix and Cross-Border Transactions11:31 - McKinsey's Perspective on Asian Innovation26:58 - Final Thoughts and Registration InformationTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

White House plans to slash FDA and NIH risk decimating two agencies at the core of U.S. biomedical innovation. On the latest BioCentury This Week podcast, BioCentury’s editors assess draft plans by the Trump administration that seek to halve FDA staff, cut NIH, and reduce overhead payments to academic institutions. The policy addressed in a recent Guest Commentary for BioCentury, “Defending the NIH, the NSF and the foundation of American science,” by the Scleroderma Research Foundation’s Luke Evnin, Peter Rubin of No Patient Left Behind, and Ra Capital’s Peter Kolchinsky.BioCentury’s team also discusses how biotechs are becoming increasingly successful at navigating the obstacles to get precision therapies across the FDA finish line.View full story: https://www.biocentury.com/article/65503400:00 - Introduction00:59 - FDA, NIH & Trump 2.016:26 - Biotechs & Precision MedicineTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text