Pink Sheet reporter and editors discuss Moderna CEO’s Stéphane Bancel’s defense of his company and COVID-19 vaccine pricing at the Senate Health, Education, Labor and Pensions Committee, the NIH denying a petition to use government march-in rights for Xtandi, and Tofersen receiving a positive US FDA advisory committee recommendation for use in ALS.

Pink Sheet reporters and editors discuss US FDA advisory committee members’ concerns about two proposed RSV vaccines, Lilly’s plan to lower the cost of its insulin products, proposed changes to the Orphan Drug Act, and the departure of the influential leader of the FDA’s neuroscience office.

Pink Sheet reporters and editors discuss the impact of PhRMA’s new push to limit Medicare price negotiations, Congress’ interest in FDA advisory committee reforms, and concerns about the COVID-19 vaccine strain selection process.

Pink Sheet reporters and editors discuss concerns related to the FDA’s announcement of a COVID-19 vaccine safety investigation, 2022 novel drug approval data, and a new guidance on cancer vaccine dose optimization.

Pink Sheet reporters and editors discuss the take-aways from Leqembi’s approval as an Alzheimer’s treatment, the new timeline for information collection and comment on Medicare price negotiations, and the reasons a generic drugs trade association CEO departed.