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February 4, 2013
15:54 EDTEBSThe Bank of NY Mellon reports 7.93% passive stake in Emergent BioSolutions
News For EBS From The Last 14 Days
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April 22, 2014
07:07 EDTEBSEmergent BioSolutions initiates manufacturing of BioThrax lots in Building 55
Emergent BioSolutions announced that it has initiated manufacturing of BioThrax consistency lots in Building 55, following review by the U.S. Food and Drug Administration of the Manufacturing and Non-Clinical Study Protocols submitted by the company supporting the Building 55 comparability program. The goal of the comparability program is to generate data that will show BioThrax manufactured at large scale in Building 55 is comparable to the BioThrax currently manufactured in the approved facility, Building 12. BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease. The Manufacturing and Non-Clinical Study Protocols reviewed with FDA specify the criteria by which product manufactured in Building 55 will be determined as comparable to BioThrax currently produced in Building 12. The company has initiated manufacturing consistency lots of BioThrax in Building 55 to demonstrate comparability and for use in the pivotal non-clinical study, which is scheduled to begin this year. Data from this non-clinical study, together with the comparability data from these consistency lots, will be used to support a Prior Approval Supplement to the BioThrax licensed BLA for the approval of Building 55. Building 12 produces 7 to 9 million doses of BioThrax annually. Building 55 has the potential to triple manufacturing capacity to an estimated 20 to 25 million doses annually.
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.
April 16, 2014
07:25 EDTEBSEmergent 'successfully' completes BioThrax clinical study
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