BioCentury This Week
BioCentury This Week
BioCentury
Ep. 360 - FDA’s FIH plans. Plus: billion-dollar deals, funds
33 minutes Posted Apr 14, 2026 at 12:00 am.
Sponsor Message: IQVIA Biotech
FDA First-in-Human
America First PDUFA Policy
Gilead Buying Tubulis
Blackstone's New Fund
Jeito Capital
Parker Institute
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Show notes
A pathway proposed by FDA to cut the time it takes biopharma companies to get to first-in-human trials is more ambitious than similar policies in Australia, China and the U.K. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the proposal, as well as a concession for the biopharma industry on first-in-human studies in PDUFA reauthorization negotiations with FDA. The analysts also discuss the latest pair of billion-dollar biotech deals: Gilead's $3.2 billion takeout of a...