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.

Abbvie, Amgen, Novartis and Novo Nordisk have drugs on the list but haven’t sued yet. While they could add to the ranks of legal opposition, the Court Battle for the IRA is more about philosophy than numbers.

Oral contraceptive’s ad did not contain any risk information and was not submitted to US FDA beforehand, so the letter seems an easy call. But with two citations released in as many weeks, is the agency signaling an uptick in enforcement?

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.

If ruling against US FDA by 5th Circuit is enacted, access to the medication abortion would revert to pre-2016 restrictions, meaning the product would be indicated for a maximum gestational age of forty-nine days and would need to be administered in person.

The former US FDA commissioner turned venture CEO believes the biopharmaceutical industry can cure many of society’s ills, but firms need to talk to the agency more.