Biopure delays US submission for blood substitute:
This article was originally published in Clinica
Executive Summary
Biopure has delayed by around six months plans to file a marketing application in the US for its blood substitute, Hemopure. The company previously said it would file a biologic licence application (BLA) for the product to the FDA by the end of 2001. The delay comes as a result of the company's plans to increase the production capacity of its Cambridge, Massachusetts manufacturing plant, a move that calls for additional facility and process validation requirements for the BLA filing. As a result, Biopure is targeting the filing for mid-2002 or sooner, depending on discussions with the FDA.
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