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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.
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December 17, 2014
07:10 EDTEBSEmergent BioSolutions acquires antibiotics portfolio
Emergent BioSolutions announced that it has acquired the EV-035 series of molecules from Evolva Holding SA. EV-035 is a series of novel small molecule broad spectrum antibiotics of the 4-oxoquinolizine class and targets bacterial type IIa topoisomerase. The lead molecule in the series, GC-072, has demonstrated protection in vivo from lethal B. pseudomallei infection when administered orally. GC-072 is being developed as a potential oral and IV treatment for B. pseudomallei under a three-year, $15M contract with the Defense Threat Reduction Agency, or DTRA, of the U.S. Department of Defense. B. pseudomallei is a gram-negative pathogen classified by the Centers for Disease Control and Prevention as a Category B bioterrorism agent and a priority threat capable of being easily weaponized and disseminated. The scope of the DTRA contract includes investigating GC-072 as a treatment for B. pseudomallei in preclinical in vitro and in vivo studies, conducting formulation, manufacturing and toxicology studies, exploring efficacy in additional multi-drug resistant biodefense and commercial pathogens, and preparing an Investigational New Drug application for submission to the FDA.
05:24 EDTEBSEmergent BioSolutions to acquire EV-035 series from Evolva
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