Pink Sheet Podcast: Amylyx’s Adcom Success, Trials Leave Russia, Apolitical Drug Price Negotiations
Pink Sheet reporters and editors discuss the positive advisory committee recommendation for Amylyx’s proposed ALS treatment, the striking drop in clinical trials conducted in Russia following the start of the war in Ukraine, and questions about Medicare price negotiations avoiding political influence.
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Pink Sheet Podcast: More US FDA Communication Problems, 2022 Novel Approval Trends, Cancer Drug Dosing Guidance
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.