GlaxoSmithKline (NYSE:GSK) and Theravance, Inc. (NASDAQ:THRX) report that their new drug application for the once-daily investigational medicine FF/VI for patients with chronic obstructive pulmonary disease was accepted by the FDA, which indicates that the application is sufficiently complete to allow a substantive review.
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Biogen IDEC Inc. (NASDAQ:BIIB) and its partner Swedish Orphan Biovitrum (BIOVF.PK) are receiving positive top-line results from an evaluation of their clotting factor candidate for patients suffering from hemophilia B. The recombinant Factor IX Fc fusion protein was “generally well tolerated” and offers an increased long-lasting treatment than current therapies which require as many as three intravenous injections per week.