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News Breaks
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.
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March 25, 2015
07:08 EDTEBSEmergent BioSolutions receives FDA approval of Anthrasil
Emergent BioSolutions announced that the FDA has approved Anthrasil, Anthrax Immune Globulin Intravenous, also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs. Achievement of this milestone triggers a $7M payment to the company under a development contract with the Biomedical Advanced Research and Development Authority. Anthrasil has received Orphan Drug designation and as a result of this approval, the product qualifies for seven years of market exclusivity.
March 24, 2015
07:13 EDTEBSEmergent BioSolutions awarded $31M contract for advanced development of NuThrax
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March 16, 2015
07:32 EDTEBSEmergent BioSolutions signs agreements with GSK, Oxford University, NIAID
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