Sanofi & GSK Win COVID-19 Vaccine Approval In EU Using Immunobridging Trials
New Biosimilar And Generic Drugs Also Get EMA Nod
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.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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.
The opioid, which has been used as a cough suppressant since the 1950s, should no longer be marketed, according to a safety review by the European Medicines Agency.