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News Breaks
December 28, 2012
12:43 EDTEBSEmergent BioSolutions secures U.S. commercial rights to influenza vaccine
Emergent BioSolutions announced that it has signed a license agreement with VaxInnate Corporation under which Emergent acquired the exclusive right to manufacture and sell VaxInnate's pandemic influenza vaccine candidate in the United States. The product candidate, a recombinant vaccine, has the potential to be produced quickly, at high yields and in a cost-effective manner. This license enables Emergent to fulfill the requirement to secure a pandemic influenza vaccine candidate under its contract with the Biomedical Advanced Research and Development Authority.
News For EBS From The Last 14 Days
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November 10, 2014
07:29 EDTEBSEmergent BioSolutions seeks expanded BioThrax label
Emergent BioSolutions announced that it has submitted a supplemental Biologics License Application to the FDA seeking to expand the label of BioThrax to include a post-exposure prophylaxis indication. BioThrax, the only FDA-licensed vaccine to prevent anthrax disease, is currently licensed for a pre-exposure prophylaxis indication only. The company made a Request for Priority Review Designation to potentially reduce the anticipated approval of this application to six months. The sBLA proposes to expand the BioThrax indication to include a post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure when combined with the recommended course of antimicrobials in persons 18 through 65 years of age. The vaccination schedule consists of three doses of BioThrax administered at 0, 2, and 4 weeks post-exposure.

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