FDA seeks information on Biopure's blood substitute:
This article was originally published in Clinica
The US FDA has completed its review of Biopure's blood substitute marketing application and has onlyasked for more information on the clinical trial data. No new studies of the product, called Hemopure, have been requested. Following the announcement on Friday, August 1, shares in the Cambridge, Massachusetts firm shot up by 22%. The FDA's response comes one month in advance of the August 29 deadline it had set (see Clinica No 1060, p 18) for ruling on the use of Hemopure as a treatment for acutely anaemic patients undergoing orthopaedic surgery.