Pink Sheet Podcast: US FDA Thoughts on Aduhelm, Stephen Hahn Interview, Potential Adcom Reforms
Pink Sheet reporters and editors discuss new Aduhelm documents explaining the FDA’s views on the accelerated approval, comments from the former FDA commissioner on his tenure and future, and options for improving advisory committee meetings.
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Pink Sheet reporters and editors discuss Viatris receiving the first interchangeable biosimilar designation, CMS hearing from stakeholders about Aduhelm and other Alzheimer’s drugs, and concerns about expanding pediatric coronavirus vaccine trials to look for rare adverse events.
Pink Sheet reporters and editors discuss another explanation of the FDA’s Aduhelm label, the first lawsuit attempting to force the sale of samples for generic development, and the agency questioning promotion of Amgen’s Neulasta.
News and views from day four of the BIO Digital annual meeting include the FDA's plans to use carrots not sticks to improve diversity and reflections on how the pandemic has strengthened biopharmaceutical supply chains.