BioCentury This Week

The biotech community is reeling, fearful and furious about the fallout of tariff, FDA and NIH policies, according to BioCentury’s newly released Risk Sentiment survey. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from the survey, which polled 328 biopharma stakeholders during April 10-14. The editors dissect the latest from Washington, including comments from FDA Commissioner Marty Makary on a new pathway for ultrarare drugs and his plans to reform advisory committee meetings, as well as last week’s executive order on drug pricing. They also discuss how China’s biotechs may have cracked one of the key bottlenecks for both speeding up and de-risking early drug development — and what this means for U.S. biotech. This episode of BioCentury This Week podcast was sponsored by RemeGen.View full story: https://www.biocentury.com/article/655690#biotech #biopharma #pharma #lifescience #FDA #politics #policy #law00:01 - Sponsor Message: RemeGen Co.02:00 - Sentiment Survey20:18 - Makary's FDA Plans29:51 - China SpeedTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

FDA’s plan to move away from animal toxicity testing could expedite INDs and cut costs for biopharma companies, while helping the U.S. maintain its position as a clinical research hub. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the agency’s new three-year road map to reduce animal safety studies for mAbs. The editors then discuss the deepening morale crisis at FDA after HHS Secretary Robert F. Kennedy Jr. accused the agency of corruption, encouraged staff to report supervisors over approval decisions they oppose, and endorsed conspiracy theories about the “deep state.” They assess the impact of whipsawing tariff policies and turmoil at FDA on biotech indexes — and why the sky isn’t falling just yet for biotech’s specialist investors. The editors also highlight recent stories on base editors’ efficiency boom and how exosomes are finding new life. This episode of BioCentury This Week podcast was sponsored by RemeGen.View full story: https://www.biocentury.com/article/65562200:01 - Sponsor Message: RemeGen Co.02:38 - Replacing Animal Models09:40 - RFK Jr. & FDA19:36 - NIH30:02 - BioPharma Market Pulse33:23 - Innovation HighlightsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Loss of leadership, cuts to staffing and a proposed reorganization at FDA have heightened biotech risk amid an already turbulent macroeconomic climate, according to BioCentury’s Washington editor Steve Usdin. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the turmoil at FDA could affect a sector already grappling with the uncertainty brought by the Trump administration’s trade war.The editors also explore the growing pipeline of VEGF-targeted bispecifics in a preview of upcoming presentations at annual meeting for the American Association for Cancer Research (AACR). And they discuss how companies may once again need to lean on their bear market survival toolkit, as part of BioCentury’s 2Q25 Financial Markets Preview. This episode of BioCentury This Week was sponsored by RemeGen Co.View full story: https://www.biocentury.com/article/65556600:01 - Sponsor Message: RemeGen Co. 01:19 - FDA and Tariffs Turmoil16:54 - AACR Preview20:44 - Bear Market ToolkitTo submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

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