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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.
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September 8, 2014
13:53 EDTEBSEmergent BioSolutions awarded contract valued at up to $29M with NIAID
Emergent BioSolutions has signed a contract with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to develop a dry formulation of NuThrax, also known as AV7909, the company’s next generation anthrax vaccine candidate. This five-year contract, valued at up to $29M, provides funding for manufacturing and non-clinical activities through the preparation of an Investigational New Drug application to the U.S. Food and Drug Administration. The dry formulation of NuThrax is intended to increase stability of the vaccine candidate at ambient and higher temperatures, with the objective of eliminating the need for cold chain during shipping and storage. NuThrax is comprised of BioThrax in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909. The company is currently conducting a randomized, parallel-group, active-controlled, double-blind Phase 2 study designed to evaluate the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection using two- and three-dose immunization schedules and two dose levels. This development contract HHSN272201400038C will be administered through NIAID, part of the National Institutes of Health of the U.S. Department of Health and Human Services.
10:51 EDTEBSEmergent BioSolutions receives $29M HHS contract
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