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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The Citeline Awards celebrate the efforts of biopharma research and development communities, with 12 categories ranging from use of technology to quality results. Nominations are open through 20 January 2023.
Pink Sheet Podcast: RWE’s Limited Uses So Far, Learning Pandemic Lessons, COVID-19 Vaccine Reporting Changes
Pink Sheet reporters and editors discuss the role of real world evidence in US FDA product decisions, staffing and other problems that are limiting the agency’s ability to implement lessons from the pandemic, and updates to COVID-19 vaccine adverse event reporting requirements.
FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’