Pink Sheet Podcast: BIO CEO Departs, Makena Withdrawal Hearing Nears, New Confirmatory Evidence Sources
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.
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Pink Sheet Podcast: Moderna CEO On Capitol Hill, Xtandi March-In Rights, Tofersen Adcomm In ALS
Pink Sheet reporter and editors discuss Moderna CEO’s Stéphane Bancel’s defense of his company and COVID-19 vaccine pricing at the Senate Health, Education, Labor and Pensions Committee, the NIH denying a petition to use government march-in rights for Xtandi, and Tofersen receiving a positive US FDA advisory committee recommendation for use in ALS.
Pink Sheet Podcast: RSV Vaccine Questions, Lilly Lowers Insulin Cost, Orphan Drug Act Changes
Pink Sheet reporters and editors discuss US FDA advisory committee members’ concerns about two proposed RSV vaccines, Lilly’s plan to lower the cost of its insulin products, proposed changes to the Orphan Drug Act, and the departure of the influential leader of the FDA’s neuroscience office.
Publisher’s Spotlight: Citeline Awards 2023 Finalists Announced
We are delighted to announce the shortlist for the seventh annual Citeline Awards, recognizing clinical and research excellence across the biopharmaceutical, CRO and diagnostics industries.