The Chicago-based pharmaceutical company Abbott Laboratories announced last month preliminary results of a phase IIb (mid-stage) study designed to test the efficacy of an oral three-drug combination therapy to suppress the hepatitis C virus (HCV).
Baxter International, Inc., announced in December 2012 the Phase I/III study results evaluating the safety and efficacy of BAX 326, a recombinant factor IX (rFIX) product for the treatment and prophylaxis of bleeding episodes for patients with hemophilia B who are more than 12 years old.
CSL Behring announced last month that the first patient had been enrolled in a phase III clinical study to evaluate the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX (FIX) with recombinant albumin (rIX-FP) in previously treated children up to 11 years old.
Green Cross Corporation (GCC), a Yongin, Korea-based pharmaceutical company specializing in plasma-derived and recombinant products for the treatment of rare and chronic conditions, recently announced the initiation of a phase III clinical study.
Baxter International, Inc., announced the results of a Phase III study evaluating FEIBA NF, the company’s plasma-derived activated prothrombin complex concentrate (aPCC) for use in patients with inhibitors to infused factor VIII or IX.
In January Biogen Idec submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for marketing approval of the company’s long-lasting recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of individuals with hemophilia B.
Last month, the US Food and Drug Administration (FDA) rescinded the seven-year orphan drug exclusivity for Octapharma’s Wilate®, an injectable human plasma-derived von Willebrand factor (VWF)/factor VIII (FVIII) concentrate for the treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von Willebrand disease (VWD).