Crucial Moment In EU For Sanofi/GSK’s COVID-19 Vaccine, Amicus’s AAT-GAA & Y-mAbs’ Omburtamab
Vidprevtyn, from Sanofi/GSK, and drugs from Amicus and Y-mAbs are nearing the end of the European Medicines Agency review cycle. They are among the products scheduled for discussion this week by the CHMP, the EMA committee that decides whether drugs should be granted pan-EU approval.
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The European Medicines Agency said it was possible to use immunobridging studies to authorize COVID-19 vaccines now that a number of COVID-19 vaccines authorized in the EU are proven to be safe and effective and can be used as comparators in trials.
Keeping Track: Gilead Gets CRL For Bulevirtide, CytoDyn Withdraws Leronlimab; Eye and CNS Drug Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Even in a rare disease with no approved treatments, the agency shows once again that without clear efficacy data, FDA has few options for approval.