Infographic: One of the more prominent arguments against the Medicare drug price negotiation program is that by limiting the number of years that products can be marketed before price caps are imposed, the scheme discourages development of additional indications.

Pink Sheet reporters and editor discuss take-aways from the first Medicare price negotiation program public listening sessions, next steps after Sarepta reported questionable top-line data for its Duchenne muscular dystrophy gene therapy Elevidys, and indications the FDA may adjust its regulatory approach to gene editing products.

Pink Sheet reporters and editor discuss the problems that emerged for the US FDA from just the threat of a government shutdown, take-aways on the FDA advisory committee process based on the complete response letter issued for Alnylam’s Onpattro, and incentives that the FDA could offer for ARPA-H projects that reach the application stage.

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?