Breaking News, Trials & Filings

GSK’s Rotarix BLA Accepted for Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has accepted for review GlaxoSmithKline’s BLA for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis. If approved, the GSK candidate vaccine could offer completion of the rotavirus vaccination series by four months of age. The rotavirus candidate vaccine is a live-attenuated vaccine derived from the most common human rotavirus strain. The BLA for the rotavirus candidate vaccine includes data from clinical trials conducted in the Americas, Euro...

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