Pink Sheet reporters and editors discuss the largest pharma companies’ pending applications, the FDA delaying its decision on Sarepta’s gene therapy in Duchenne muscular dystrophy, and a plan to add more temporary members to agency advisory committees … as well as a little bit of “The Simpsons.”

Pink Sheet reporters and editors discuss questions about Sarepta’s Duchenne muscular dystrophy gene therapy candidate, the US FDA’s efforts to simplify the COVID-19 vaccine schedule, and industry’s ideas for Medicare price negotiation system changes.

Pink Sheet reporters and editors discuss the FDA’s upcoming advisory committee meeting for the controversial ALS cell therapy NurOwn, a proposal to batch test all drugs coming into the US amid problems conducting foreign inspections, and the FDA’s return to in-person meetings with industry.

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.