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.

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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.

Pink Sheet reporters and editors discuss the nearly wide open 2024 FDA advisory committee calendar, CMS’s impact on Florida’s drug importation plan, and the FDA’s many missed user fee goals in 2023.