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Contract research organization leaders weigh in on how to avoid some recent pitfalls seen at US FDA advisory committee panels.
Plus deals involving Sanofi/SIRION, Merck KGAA/Day One, Beijing Tide/Graviton, Vaccinex/Surface Oncology, Athena/Tris, Biomunex/Onward, Cellectis/Cytovia
US FDA’s global first for Moderna’s vaccine gets a small mention as agency looks to pharmacovigilance, follow-up studies for both coronavirus inoculations that have now been authorized. Moderna's 18 December EUA comes after an even faster review than for Pfizer/BioNTech's vaccine.
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.
- Contract Research Organization-CRO
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