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.

Pink Sheet reporters and editors discuss a projected decline in accelerated approvals by the US FDA, a new CMS proposed rule requiring generic drug cost sharing tiers, and the negative advisory committee recommendation for Cytokinetics’ proposed heart failure treatment.

Pink Sheet reporters and editors discuss lessons from the public hearing on the proposed withdrawal of the preterm birth prevention drug Makena, FDA Commissioner Califf’s opinion that industry is not meeting expectations with accelerated approval confirmatory studies, and agency efforts to clarify that staff is paying attention to comparative claims in product ads.

Pink Sheet reporters and editors discuss Michelle McMurry-Heath’s surprising departure as head of a top biotech industry trade association, preview the FDA hearing to withdraw the preterm birth prevention drug Makena, and consider Amylyx’s Relyvrio seemingly opening a wider path to gather confirmatory evidence for approval.

Pink Sheet reporters and editors discuss the newly approved ALS drug Relyvrio, the promising data on the Alzheimer’s drug lecanemab, and CMS’s efforts to build the drug price negotiation program.