Stephen Hahn On Risk-Taking, Moving To ‘Friction,’ And What Industry Can Learn From The FDA
The former US FDA commissioner turned venture CEO believes the biopharmaceutical industry can cure many of society’s ills, but firms need to talk to the agency more.
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Pink Sheet Podcast: Regeneron’s COVID Monoclonal Deal, New FDA Advisor, Project Optimus In Cancer Combos
Pink Sheet reporter and editors discuss the somewhat novel pricing language in Regeneron’s deal with the US government to develop a COVID-19 monoclonal antibody, US FDA Commissioner Robert Califf hiring a new senior advisor, and optimizing dosing in cancer combination therapies.
Abbvie, Amgen, Novartis and Novo Nordisk have drugs on the list but haven’t sued yet. While they could add to the ranks of legal opposition, the Court Battle for the IRA is more about philosophy than numbers.
Advertising Untitled Letter For Exeltis Slynd Social Media Spot Renews Attention To Online Risk Disclosure
Oral contraceptive’s ad did not contain any risk information and was not submitted to US FDA beforehand, so the letter seems an easy call. But with two citations released in as many weeks, is the agency signaling an uptick in enforcement?