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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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November 10, 2014
07:29 EDTEBSEmergent BioSolutions seeks expanded BioThrax label
Emergent BioSolutions announced that it has submitted a supplemental Biologics License Application to the FDA seeking to expand the label of BioThrax to include a post-exposure prophylaxis indication. BioThrax, the only FDA-licensed vaccine to prevent anthrax disease, is currently licensed for a pre-exposure prophylaxis indication only. The company made a Request for Priority Review Designation to potentially reduce the anticipated approval of this application to six months. The sBLA proposes to expand the BioThrax indication to include a post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure when combined with the recommended course of antimicrobials in persons 18 through 65 years of age. The vaccination schedule consists of three doses of BioThrax administered at 0, 2, and 4 weeks post-exposure.

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