FDA delays Biogen's application on hemophilia B therapy

The FDA has delayed a decision on Biogen Idec's ($BIIB) hemophilia B therapy Alprolix. At the agency's request the Big Biotech provided additional information on a manufacturing step used for the long-lasting recombinant factor IX candidate Alprolix. Regulators will now add three months to the PDUFA deadline to review the new information. Release

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