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This section features all recent CSL Behring news releases. Click the tabs to select releases in your area of interest. Click Resources to find additional background material on CSL Behring.

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Bleeding Disorders

04 June 2013 CSL Behring Doses First Patient in Part 3 of Global Phase I/III Pivotal Study of rVIII-SingleChain (Recombinant Single-Chain Factor VIII) for Treatment of Hemophilia A

CSL Behring has dosed the first patient in Part 3 of its AFFINITY clinical trial program, which is now in phase III. AFFINITY is an open-label, non-randomized multi-center study evaluating the efficacy, safety and pharmacokinetics of its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) for the treatment of hemophilia A. The patient was dosed in Vienna, Austria and had a successful major surgery.

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30 April 2013 CSL Behring Receives FDA Approval of Kcentra™ for Urgent Warfarin Reversal in Patients with Acute Major Bleeding

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) approved Kcentra™ (Prothrombin Complex Concentrate [Human]), the first non-activated 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding. The pivotal clinical trial showed that Kcentra met all efficacy and safety endpoints, including the endpoints of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma, the most widely used agent for warfarin reversal in the United States.

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03 April 2013 CSL Behring Donates Medicine Used in Treating Bleeding Disorders to World Federation of Hemophilia

As part of its ongoing commitment to the global coagulation disorders community, CSL Behring will again donate factor product to the World Federation of Hemophilia (WFH) in connection with World Hemophilia Day this month. The medicine will be used in treating patients in developing countries and who have certain types of bleeding disorders. The donation supports WFH’s progress in improving the diagnosis and treatment of bleeding disorders through its Global Alliance for Progress (GAP) program. CSL Behring’s current donation includes product used in treating von Willebrand Disease (VWD) and hemophilia. The total volume of product being donated in this installment is approximately 1,000,000 international units.

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28 February 2013 CSL Behring Receives FDA Approval to Expand the Indication for Corifact®

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, Factor XIII Concentrate (Human), to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the U.S. for the routine prophylactic treatment of congenital factor XIII deficiency.

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21 January 2013 CSL Behring Enrolls First Patient in Global Pediatric Phase III Pivotal Study of Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) to Treat Hemophilia B

CSL Behring has announced that the first patient has been enrolled in the pivotal pediatric phase III study to evaluate the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) in previously treated children (up to age 11 years). The study site for this first enrollment is the Czech Republic.

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