The BioCentury Show

With new governments both side of the pond, capital markets picking up, and some geopolitical overhang, there’s a mixed feast for biotech, with a net trend to the positive, says Sidley Austin’s Robert Darwin, who specializes in global M&A and private equity for life sciences and healthcare companies and investors. In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Darwin, who is based in London, discussed the consequences for biotech of the changing forces as we enter 2025: the new Labour government’s recently announced budget, the incoming Trump administration, the improving outlook for the markets, and the ongoing — if not mounting — tensions between the U.S. and China. Across each of these is a considerable amount of uncertainty, but the pluses and minuses add up to net positive outlook, he believes.This episode of The BioCentury Show was sponsored by Cytiva. View full story: https://www.biocentury.com/article/654182#biotech #biopharma #pharma #lifescience #deals00:00 – Introduction01:49 – U.K.’s Place in Global Biotech09:41 – Trump & Biotech17:32 – Deals in 202531:57 – Private Equity in Biotech

Richard Pazdur, director of FDA’s Oncology Center of Excellence, joined FDA in 1999. Looking back on his 25th anniversary, he draws a line between unpopular decisions at the start of his tenure and a surge in cancer drug development over the last 20 years. He believes this and other lessons from the regulation of oncology can be applied broadly across FDA. The BioCentury Show discussed these lessons, as well as Pazdur’s views about advisory committees, pragmatic trials, dose optimization and more. This episode of The BioCentury Show was sponsored by Cytiva.View full story: https://www.biocentury.com/article/654032#biotech #biopharma #pharma #lifescience #RandD #drugapproval #regulation00:00 - Introduction01:55 - Rejecting the ineffective10:56 - Creating Consensus16:43 - Fire From the Dragon’s Mouth24:30 - Three Reasons for Trial Equity29:28 - Dose Optimization

With most of the highly attractive late-stage assets already scooped up, pharmas are turning their sights to Phase II companies, and lining up their case to make an attractive offer and move fast. About 40% of the M&A deals in 2023-24 were completed in less than six weeks, from approach to announcement, according to Lazard’s data. Michael Kingston and Dale Raine, global co-heads of biopharma at Lazard, joined The BioCentury Show this week to discuss the M&A outlook amid the still-precarious biotech financing landscape.View full story: https://www.biocentury.com/article/653858#biotech #biopharma #pharma #lifescience #IPO #capitalmarkets #deals00:00 - Introduction02:17 - Capital Markets Outlook05:18 - M&A14:37 - Breaking Down Deals23:44 - Asia

CMS’s controversial decision to restrict access to Alzheimer’s mAb treatments, including Aduhelm, approved under FDA’s accelerated pathway was a unique case that is unlikely to set a precedent, former CMS CMO Lee Fleisher told BioCentury. “I do not think this will be repeated,” he said. In an interview with The BioCentury Show's Steve Usdin, Fleisher gives a behind-the-scenes account of the decision-making process, including the role of accelerated approval. He also discusses the opportunities and risks for healthcare posed by AI, and the scientific and legislative steps that will be needed to make real the promise of blood-based multicancer detection technologies.View full story: https://www.biocentury.com/article/653749#biotech #biopharma #pharma #lifescience #policy00:00 - Introduction01:31 - Behind the Aduhelm Decision08:01 - Questioning CMS17:19 - Accelerated Approval26:34 - AI in Medicine