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Blood Substitutes
Agency Takes Adverse Decision to Biopure's Product Registration in South Africa
November 15th, 2008
Biopure Corporation (NASDAQ:BPUR) announced that it had received a notice from the Medicines Control Council (MCC) of South Africa indicating its decision to discontinue the registration of Hemopure [hemoglobin glutamer-250 (bovine)], Biopure's oxygen therapeutic for human use. The decision is subject to appeal. Biopure intends to appeal the decision promptly and expects to continue to market the product while the appeal is pending. The appeal is estimated to take a year to resolve. The MCC decision comes after a letter sent to the South Africa Minister of Health on May 22, 2008, asking that the then ongoing clinical trials of Hemopure in South Africa be brought to a...
Source: Law & Health Weekly (2008-11-15)
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