Mark McClellan discusses whether CMS’s pending final version of the Medicare national coverage determination on Alzheimer’s drugs might change from the draft and whether the decision should be viewed as a precedent for drugs granted accelerated approvals.

Pink Sheet reporters and editors discuss how the hearings for the withdrawal of Avastin’s accelerated approval in breast cancer could inform the same process for Makena, Robert Califf’s view that public trust in the agency will be rebuilt, and a request to increase the dispensing fees associated with COVID-19 treatments Paxlovid and molnupiravir.

Medtech Insight spoke to the manufacturers of the smallest commercially available insulin pump to learn more about how it works, the market factors impacting it, and how scaling up a business can throw up unexpected challenges.

Internal emails show the 2011 hearing on Genentech’s VEGF-inhibitor was taxing for FDA employees, who had to deal with a number of novel issues; the workload is likely to be similarly complex for staff involved in upcoming hearing on Covis’ preterm birth prevention drug Makena.