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 antibody-drug conjugate company Tubulis and the acquisition of Soleno by Neurocrine for $2.9 billion for its Prader-Willi asset. Finally, BioCentury’s analysts discuss the new $6.3 billion Blackstone Life Sciences fund and the €1 billion vehicle unveiled last week by European VC Jeito Capital. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech.

View full story: https://www.biocentury.com/article/659127

#FDA #FirstInHuman #BiotechMergers #BiotechInvesting #LifeSciencesVC

00:01 - Sponsor Message: IQVIA Biotech
03:24 - FDA First-in-Human
11:44 - America First PDUFA Policy
17:43 - Gilead Buying Tubulis
23:41 - Blackstone's New Fund
28:37 - Jeito Capital
30:44 - Parker Institute

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Ep. 360 - FDA’s FIH plans. Plus: billion-dollar deals, funds