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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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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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September 2, 2014
20:31 EDTEBSEmergent BioSolutions management to meet with JPMorgan
Meetings to be held in the Mid-Atlantic area on September 4-5 hosted by JPMorgan.

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