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Dec 09, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Alprolix rFIXFc regulatory update

Biogen Idec said FDA extended by 3 months the PDUFA date for a BLA for Alprolix rFIXFc to treat hemophilia B. According to the company, the delay was due to the submission of additional information on the validation of a manufacturing step for the recombinant fusion protein consisting of human coagulation...

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