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 increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

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.

Pink Sheet reporters and editors discuss the implications of Aduhelm’s updated indication, CDER’s new drug approvals in the first half of 2021, and an FTC policy change that will make investigating pharma easier.

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.

Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.

Pink Sheet reporters and editors discuss the end of stem cell clinic enforcement discretion, the US FDA’s projection that inspections will return to normal levels in FY 2022, and improved hiring in CDER.