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FDA Approves Emergent’s Smallpox Vaccine

Will manufacture ACAM2000 in newly-acquired cGMP live viral manufacturing facility in Canton, MA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Emergent BioSolutions said that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the manufacture of ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) in the company’s newly-acquired cGMP live viral manufacturing facility in Canton, MA. ACAM2000 is the only FDA-licensed vaccine for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. “Finalizing and receiving FDA licensure fo...

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