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April 21, 2014
07:08 EDTEBSEmergent receives BioThrax orphan drug designation
Emergent BioSolutions that the U.S. Food and Drug Administration has granted orphan drug designation to BioThrax for post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. This designation provides incentives to the BioThrax PEP Program, including the waiver of the Biologics License Application supplemental regulatory filing fee and marketing exclusivity of up to seven years. Emergent recently announced completion of a non-interference study, results from which will be used to support a supplemental BLA seeking licensure of a PEP indication for BioThrax to be used in combination with antibiotics in people with suspected or confirmed exposure to anthrax spores. This study is fully funded under contract number HHSO100200700037C provided by the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
News For EBS From The Last 14 Days
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August 19, 2014
17:33 EDTEBSEmergent BioSolutions, MorphoSys sign license agreement for ES414
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August 7, 2014
16:23 EDTEBSEmergent BioSolutions sees Q3 revenue $110M-$125M, consensus $125.17M
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16:22 EDTEBSEmergent BioSolutions raises FY14 revenue view to $425-$450M from $415M-$445M
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16:20 EDTEBSEmergent BioSol' reports Q2 GAAP EPS 13c, may not compare with consensus 32c
Reports Q2 revenue $110.3M, consensus $109.25M.
07:13 EDTEBSEmergent BioSolutions submits BLA to FDA for AIGIV
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