BioCentury
PODCAST | Product Development

NASH ups and downs, COVID-19 vaccines & real-world data for diagnostics: a BioCentury podcast

July 6, 2020 11:52 PM UTC

The path to authorization for COVID-19 vaccines is beginning to take shape as FDA lays out its requirements and early data begin to trickle in. On the latest edition of the BioCentury This Week podcast, BioCentury editors discuss FDA’s COVID-19 vaccine guidance and the latest clinical data, plus developments in the long journey to a NASH therapy and the role of real-world data (RWD) in diagnostics.

Editor in Chief Simone Fishburn and Senior Editor Lauren Martz discuss how endpoints factored into FDA’s complete response letter for obeticholic acid (OCA) from Intercept Pharmaceuticals Inc. (NASDAQ:ICPT), and what that decision means for other NASH therapy developers including Akero Therapeutics Inc. (NASDAQ:AKRO) (see “Surrogate Endpoint Not Enough”; “Histology Data Builds on Growing Confidence Around Akero’s NASH Candidate”)...