Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation, upcoming guidance on accelerated approval for gene therapies, and partisan attacks on the agency from Capitol Hill.

Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.

Pink Sheet reporter and editors discuss Richard Pazdur’s call for more diverse opinions in FDA advisory committee meeting open public hearings, agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans, and the pending review of Stealth BioTherapeutics’ application for the Barth Syndrome candidate elamipretide.

Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed, an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees, and Japan’s PMDA opening an office in Washington D.C.

Pink Sheet reporters and editor discuss the upcoming US Supreme Court arguments on mifepristone access, the SCOTUS reaction to the fight against misinformation, and the FDA’s Oncologic Drugs Advisory Committee going against three negative product reviews.

Pink Sheet reporters and editor discuss Vanda’s decision to sue the FDA over the rejection of the Hetlioz jet lag indication, Mark Cuban’s comments at a White House event that the federal government and others should stop doing business with the big three PBMs, and the cut in non-user fee dollars in the FY 2024 FDA appropriations bill.

Pink Sheet reporters and editors discuss the FDA’s approach to psychedelic drugs, whether postmarket clinical trial data from the Alzheimer’s drug Aduhelm will be published, and the FDA offering more time to find candidates for its new Genetic Metabolic Diseases Advisory Committee.

Pink Sheet reporters and editors discuss the dismissal of PhRMA’s suit challenging the Medicare price negotiation provisions, the US FTC and HHS investigation of drug shortages, and the potential for FDA-approved marijuana products.