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Jul 3, 2013CSL Behring today announced that pharmacokinetic results for its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) showed improved half-life over octocog alfa (the comparator). It also demonstrated a safety and efficacy profile that supports advancement to late-stage clinical development. The data were presented at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
03 Jul 2013 CSL Behring today announced that pharmacokinetic results for its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) showed improved half-life...
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Jun 27, 2013CSL Behring today announced it will present study data from three ongoing clinical trial programs evaluating the Company’s novel recombinant factor VIIa (rVIIa-FP), VIII (rVIII-SingleChain) and IX (rIX-FP) agents for people with hemophilia A and B with and without inhibitors. The data will be presented at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. CSL Behring is the only company pursuing longer-acting rVIIa-FP and rIX-FP candidates based on recombinant albumin, and a rVIII-SingleChain compound that has been shown to improve the stability and half-life of factor VIII (FVIII).
27 Jun 2013 CSL Behring today announced it will present study data from three ongoing clinical trial programs evaluating the Company’s novel recombinant factor VIIa (rVIIa-FP), VIII...
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Jun 4, 2013CSL 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.
04 Jun 2013 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...
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Apr 29, 2013CSL 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.
29 Apr 2013 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...
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Apr 16, 2013CSL 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.
16 Apr 2013 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...
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Apr 4, 2013CSL 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.
04 Apr 2013 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...
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Feb 23, 2013New data from a CSL Behring analysis show that treatment with Berinert®, C1 Esterase Inhibitor (Human), provides significant resolution of cutaneous attacks of hereditary angioedema (HAE). The data were presented at the 2013 annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI). HAE is a rare, potentially fatal swelling disorder caused by a deficiency of C1 Esterase Inhibitor. (C1-INH) Cutaneous HAE attacks are characterized as skin edema or swelling, and often disable and disfigure the face and extremities at the time of the attack.
23 Feb 2013 New data from a CSL Behring analysis show that treatment with Berinert®, C1 Esterase Inhibitor (Human), provides significant resolution of cutaneous attacks of hereditary angioedema...
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Feb 23, 2013
CSL Behring announced the results of a cost-effectiveness analysis showing that on-demand treatment of hereditary angioedema (HAE) attacks with Berinert®, C1 Esterase Inhibitor (Human), provides...
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Feb 21, 2013CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size for Privigen®, immune globulin intravenous [human]. The new vial size will simplify preparation and administration of the product when high volumes of it are required. Privigen is approved for the treatment of patients with primary immunodeficiency (PID), a group of rare and serious diseases of the immune system, and provides effective protection against infection by assisting the body in maintaining a normal level of immunoglobulin. Privigen is also approved in the United States for chronic immune thrombocytopenic purpura (ITP) to raise platelet counts. With the addition of the 40 g vial, Privigen will be available in four sizes in the United States, including 5 g (50 mL), 10 g (100 mL) and 20 g (200 mL). The first supply of Privigen in this new vial size will be introduced in June.
21 Feb 2013 CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size for Privigen®, immune globulin intravenous [human]. The new vial...
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Feb 5, 2013When Donna Schlacht’s son, Carl, was diagnosed with primary immunodeficiency (PI) at age 1, she resolved to not let Carl see his disorder as a barrier to pursuing his dreams. Today, Carl is a professional Supercross racer, and is helping to launch the I Am A ChamPIon campaign to inspire others to achieve their goals despite the challenges of living with PI.
When Donna Schlacht’s son, Carl, was diagnosed with primary immunodeficiency (PI) at age 1, she resolved to not let Carl see his disorder as a barrier to pursuing his dreams. Today, Carl is a...