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May 1, 2014
05:10 EDTBOTABiota Pharmaceuticals provides update on development of laninamivir octanoate
Biota Pharmaceuticals announced that an interim update has been provided from the U.S. Department of Health and Human Services and the Biomedical Advanced Research and Development Authority, or BARDA, with respect to the Stop-Work Order the company recently received from BARDA and its pending decision regarding a recent In Process Review of its contract to support the development of laninamivir octanoate. BARDA Director Robin Robinson, Ph.D., provided the following update: "It is important to keep in mind that a Stop-Work Order is not a contract termination. We have some concerns about the project with regard to the product manufacturing, clinical study enrollment pace, costs, and contractor performance. Since the project is at a natural pause following the end of the flu season for the Northern Hemisphere, we are considering what is the best next step for the Biota project and the overall influenza antiviral drug development program before going forward with clinical studies in the Southern Hemisphere and manufacturing optimization and validation." The company has been advised by BARDA that the final decision regarding the outcome of the IPR should be forthcoming within the next week.
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February 8, 2016
07:03 EDTBOTABiota Pharmaceuticals commences dosing in Phase 2 BTA074 trial
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