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 reporter and editors discuss the first round of mandated Medicare inflation rebates and new guidance on price negotiations, consider the VA’s decision to cover the Alzheimer’s drug Leqembi, and the US FDA continuing to search for a cell and gene therapy office leader.

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 editor discuss learnings from a generic drug industry trade association conference, as well as FDA Commissioner Robert Califf’s ideas for advisory committee changes and using emergency use authorizations in non-COVID-19 areas.

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 consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.

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.