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.

Pink Sheet reporter and editors discuss the US Federal Trade Commission ending its attempt to block the Amgen acquisition of Horizon Therapeutics, a proposed public-private partnership to develop ultra-rare cancer drugs, and a slow-down in ANDA submissions to the US Food and Drug Administration.

Pink Sheet reporters and editors consider lessons and next steps after the first list of drugs subject to Medicare price negotiations was released and discuss Oncopeptides’ Pepaxto facing withdrawal under the US FDA’s new and potentially faster process.

Pink Sheet reporters and editor discuss a projected list of drugs that could be eligible for the first round of Medicare price negotiations, the future of mifepristone access after the latest court decision, and AstraZeneca receiving the first US FDA drug promotion warning letter in more than a year.

Pink Sheet reporters and editors discuss the impact of a study showing cardiovascular benefits for the weight loss drug Wegovy, another attempt to restrict mifepristone access, and a new threat to the US FDA’s hybrid work policy.

Pink Sheet reporters and editors and special guests from 3D Communications, a firm that helps sponsors prepare for advisory committee meetings, dig into the advisory committee reform debate and discuss the impact of ideas like eliminating or reducing the number of votes.

Pink Sheet reporters and editors consider the upcoming COVID-19 vaccination campaign, the virtue of advisory committees with only a few members, and the first FDA drug advertising untitled letter in a year.

Pink Sheet reporters and editors discuss CMS’s latest coverage announcement for Alzheimer’s drugs and the VA’s approach to the issue, the FDA’s new one-page patient medication information document, international convergence on COVID-19 vaccine strain selection and Novavax’s place in the vaccine toolbox going forward.