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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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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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16 April 2013 CSL Behring Receives European Health Authorities’ Approval of Berinert® for Short-Term Prophylaxis in Adults and Children

CSL Behring today announced that European health authorities have approved an extended use of Berinert®, a C1-esterase inhibitor (C1-INH) concentrate, for pre-procedure prevention (short-term prophylaxis) of acute episodes of hereditary angioedema (HAE), in adult and pediatric patients undergoing medical, dental or surgical procedures. HAE is a rare, serious and sometimes life-threatening genetic disorder.

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04 April 2013 European Commission Grants Marketing Authorization to CSL Behring’s Privigen® in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

– CSL Behring announced today that the European Commission has granted marketing authorization for the use of Privigen® (immune globulin intravenous [human], 10 percent liquid, for intravenous administration) in the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare neurological disorder of the peripheral nerves characterized by weakness in the arms and legs that progressively worsens for longer than two months. CSL Behring is a subsidiary of CSL Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne, Australia.

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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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