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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.
News For EBS From The Last 14 Days
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April 22, 2015
16:08 EDTEBSEmergent BioSolutions reaffirms outlook for 2015
Emergent BioSolutions reaffirms its previous 2015 forecast of total revenues of $510M-$540M, driven by BioThrax sales which are anticipated to be between $270M-$285M. The company also forecasts full year 2015 GAAP net income of $50M-$60M and adjusted net income of $60M-$70M.
16:06 EDTEBSEmergent BioSolutions sees Q1 revenue $62M-$62M, one estimate $51.5M
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16:06 EDTEBSEmergent BioSolutions resumes full manufacturing operations of BioThrax
Emergent BioSolutions announced that it has resumed full manufacturing operations of BioThrax after completing its internal manufacturing investigation of foreign particles discovered in a limited number of vials in two manufactured BioThrax lots. It stated, "Following a comprehensive assessment, the company has identified a supplier component as the most probable root cause. As a result, the company is implementing certain targeted corrective and preventive actions in the operations of its suppliers and contract manufacturers, as well as its own operations. The investigation concluded that there was no impact to any BioThrax in distribution or to any of the company's other products or manufacturing operations, including the company's Building 55 operations and plans for licensure."

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