Pink Sheet Podcast: Pre-Announced FDA Inspections, Vaccine Safety, On-Time Application Decisions
Pink Sheet reporters and editors consider the impact of pre-announced domestic inspections, as well as look at the various COVID-19 vaccine safety monitoring programs and new data on application decisions during the pandemic.
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Pink Sheet and Scrip editors join Datamonitor Healthcare analysts to discuss Biogen's Aduhelm for Alzheimer's disease, including the expected launch trajectory, early commercial barriers to uptake and the Medicare reimbursement environment.
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.