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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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May 6, 2015
07:26 EDTEBSCredit Suisse to hold a conference
Antibody Day 2015 to be held in New York on May 6.
April 30, 2015
07:51 EDTEBSEmergent BioSolutions announces FDA approval of Ixinity
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April 22, 2015
16:08 EDTEBSEmergent BioSolutions reaffirms outlook for 2015
Emergent BioSolutions reaffirms its previous 2015 forecast of total revenues of $510M-$540M, driven by BioThrax sales which are anticipated to be between $270M-$285M. The company also forecasts full year 2015 GAAP net income of $50M-$60M and adjusted net income of $60M-$70M.
16:06 EDTEBSEmergent BioSolutions sees Q1 revenue $62M-$62M, one estimate $51.5M
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16:06 EDTEBSEmergent BioSolutions resumes full manufacturing operations of BioThrax
Emergent BioSolutions announced that it has resumed full manufacturing operations of BioThrax after completing its internal manufacturing investigation of foreign particles discovered in a limited number of vials in two manufactured BioThrax lots. It stated, "Following a comprehensive assessment, the company has identified a supplier component as the most probable root cause. As a result, the company is implementing certain targeted corrective and preventive actions in the operations of its suppliers and contract manufacturers, as well as its own operations. The investigation concluded that there was no impact to any BioThrax in distribution or to any of the company's other products or manufacturing operations, including the company's Building 55 operations and plans for licensure."

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