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Gilead Sciences, Inc.
Gilead Sciences’ Marketing Authorisation Application for Regadenoson Validated by European Medicines Agency
June 21st, 2009
Gilead Sciences, Inc. (Nasdaq: GILD) announced that the company’s Marketing Authorisation Application (MAA) for regadenoson, an investigational pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI), was validated by the European Medicines Agency (EMEA). Following validation of the MAA, the dossier is distributed to members of the Committee for Medicinal Products for Human Use (CHMP) for formal review to determine whether regadenoson is a safe and efficacious pharmacologic stress agent in humans. The submission includes data from two identically designed Phase III clinical trials, which showed with 95 percent confidence that MPI studies conducted...
Source: Medical Letter on the CDC & FDA (2009-06-21)
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