Emergent BioSolutions Advances BioThrax Program

Phase III post-exposure study meets endpoints

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Emergent BioSolutions has met the primary and secondary endpoints of a Phase III study evaluating a three-dose BioThrax (Anthrax Vaccine Adsorbed) regimen for post-exposure prophylaxis (PEP). The company has submitted the final study report to the Biomedical Advanced Research and Development Authority (BARDA) and the FDA and the data will be used to support a sBLA. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease, but it is not currently licensed for use in a post-...

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