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/655370

00:00 - Introduction
02:09 - BIO's Trump 2.0 Plan
14:00 - Autoimmune CAR Ts
21:05 - Telix's Radiopharma Play

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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/655318

00:00 - Introduction
01:58 - Key Takeaways
08:42 - Innovation in Japan and India
12:54 - Building Biotech Ecosystems
31:14 - NewCo Model

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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/655302

00:00 - Introduction
01:10 - Makary’s FDA Agenda
10:50 - Amylin in Obesity
24:21 - Life After DEI

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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/655214

00:00 - Introduction
00:36 - CRISPR Companies
09:22 - AbbVie Enters Obesity Race
17:19 - Rare Disease Drug Challenges

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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/655157

00:00 - Introduction
00:45 - Roche Reboot
08:47 - Precision Medicine in Psychiatry
13:07 - 5 Things on Trump 2.0

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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/655112

00:00 - Introduction
00:58 - Competing with China
14:13 - FDA, NIH Staff Cuts
20:16 - Biotech IPOs 

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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/655108

00:00 - Introduction
04:49 - The Newco Model and Industry Trends
09:13 - BayHelix and Cross-Border Transactions
11:31 - McKinsey's Perspective on Asian Innovation
26:58 - Final Thoughts and Registration Information

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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/655034

00:00 - Introduction
00:59 - FDA, NIH & Trump 2.0
16:26 - Biotechs & Precision Medicine

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The boom in the creation of companies that were launched in the West based on assets sourced in Asia signals China’s galloping speed of innovation. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the “NewCo Model,” who the players are, from CEOs and companies to investors; the areas of innovation the start-ups are tackling; and the evolution of the trend. (Read about the company that kicked off the trend, Arrivent, here.)
The editors also assess how personnel losses at FDA from the Trump administration’s plans to slash government payrolls are likely to cause short- and long-term harm for the agency and the drug approval process. And a new pain therapy from Vertex is in the spotlight as the CF specialist enters new turf.

View full story: https://www.biocentury.com/article/654946

00:00 - Introduction
01:20 - Asia's NewCo Model
16:22 - FDA Tipping Point
20:27 - Vertex's Pain Drug

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Psychiatric drug development has had major wins over the past year-and-a-half — think Karuna Pharmaceuticals' $14 billion takeout by Bristol Myers Squibb and the subsequent launch of a new schizophrenia therapy — but targeted neuropsychiatric drug development is still in its infancy. On a special edition of the BioCentury This Week podcast, BioCentury’s editors detail the promise of precision medicine in the space and break down what recent setbacks for key players mean for next steps in the clinic. The team is joined by special guest Peter Schueler, SVP of drug development solutions, neurosciences, at ICON, who delivers takeaways from this month’s the ECNP Roadmap Meeting on Precision Psychiatry in Frankfurt and a recent white paper by ICON. This episode of BioCentury This Week was sponsored by ICON Biotech.

View full story: https://www.biocentury.com/article/654903

00:01 - Sponsor Message: ICON Biotech
02:20 - Precision Neuropsychiatry
06:39 - Insights from ICON's Peter Schueler
15:59 - Challenges in Neuropsych

To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected].

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