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Stock Market & Financial Investment News

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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May 22, 2015
14:49 EDTEBSEmergent BioSolutions files automatic mixed securities shelf
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May 19, 2015
07:06 EDTEBSEmergent BioSolutions signs manufacturing agreement with Prometic Life Sciences
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May 13, 2015
07:07 EDTEBSSoligenix signs development agreement with Emergent BioSolutions
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07:07 EDTEBSGSK, Emergent BioSolutions, Oxford initiate Prime Boost study of Ebola vaccine
A new phase 1 study has begun at the University of Oxford that will investigate the use of a modified vaccinia Ankara, or MVA, Ebola Zaire vaccine candidate, or MVA EBOZ, as a prime-boost to GlaxoSmithKline's (GSK) Chimp Adenovirus type 3, or ChAd3, Ebola vaccine candidate. The study, being conducted by the clinical research group of Professor Adrian Hill of the Jenner Institute, has received regulatory approval to begin from the United Kingdom's Medicines and Healthcare Products Regulatory Agency, or MHRA. The phase 1 study has a planned enrollment of 38 volunteers of which 6 will receive MVA EBOZ only while the other 32 will receive ChAd3-EBO-Z prime followed by MVA EBOZ boost. Emergent BioSolutions (EBS) manufactured the supply of MVA EBOZ to be used in this phase 1 study, which is being conducted in the U.K. with support from the Wellcome Trust and the U.K. Department for International Development.

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