Pfizer COVID Vaccine Trial Proved Remote Monitoring, Other Innovations Work, ICON CEO Says
Steve Cutler, head of the CRO that conducted Pfizer’s study, tells the Pink Sheet that starting clinical trials in weeks, as opposed to months, should be possible post-pandemic.
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US CBER director Peter Marks suggests CDER could join its real-time communications pilot program, CDER's Jacqueline Corrigan-Curay says the use of decentralized trials has declined since the pandemic eased, and the GAO concludes that revisions to the mifepristone REMS do not require congressional review.
Plus deals involving Sanofi/SIRION, Merck KGAA/Day One, Beijing Tide/Graviton, Vaccinex/Surface Oncology, Athena/Tris, Biomunex/Onward, Cellectis/Cytovia
Pfizer moved aggressively and early as COVID-19 became a global health threat, and now the company, with its partner BioNTech, is the first to secure an emergency use authorization for a COVID vaccine from the US FDA.