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Regeneron’s BLA for Ebola Cocktail Gets Priority Review

VelociSuite technologies facilitate rapid generation of optimized antibodies allowing for cell line production and large-scale bioreactor manufacturing

By: Contract Pharma

Contract Pharma Staff

Regeneron Pharmaceuticals received Priority Review by the U.S. FDA for a new Biologics License Application (BLA) for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection. The target action date for the FDA decision is October 25, 2020. The REGN-EB3 BLA is supported by data from the randomized, controlled PALM clinical trial demonstrating superior efficacy compared to the control arm across multiple measures, including reduced mortality and fewer days until...

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