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February 4, 2013
07:05 EDTEBSData from Phase IIb clinical trial for MVA85A published in The Lancet
Data were published in The Lancet from a Phase IIb clinical trial evaluating the safety and efficacy of MVA85A in preventing tuberculosis in infants. MVA85A is a TB vaccine candidate designed to boost immune responses already primed by the Bacille Calmette-Guérin vaccine, the currently licensed and widely used TB vaccine. Data show that a single dose of MVA85A is not sufficient to confer statistically significant protection against TB disease or infection in infants who had been vaccinated at birth with BCG. There were 32 cases of TB disease in the infants that received BCG + MVA85A compared with 39 cases of disease among those receiving BCG + placebo. Non-significant vaccine efficacy was measured at 17.3%at study completion. The vaccine candidate also did not provide statistically significant protection from infection with Mycobacterium tuberculosis, the bacterium that causes TB, which was a secondary efficacy endpoint. The study was successful in that the vaccine was well tolerated, there was no evidence of any harm to the trial participants, and it gave a clear answer.
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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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