Recent News Releases
For investor-related news, see our ASX releases here.
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May 31, 2012CSL Behring announced today that it has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen® (immune globulin intravenous [human], 10 percent liquid for intravenous administration) in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). CIDP is a rare neurological disorder of the peripheral nerves characterized by symmetrical 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.
31 May 2012 CSL Behring announced today that it has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen® (immune globulin intravenous [human], 10...
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May 29, 2012If approved by the FDA, the CSL Behring 4-factor PCC would be the first agent of its kind available in the United States.
29 May 2012 CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin...
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May 3, 2012CSL Behring announced today that it has initiated an international phase I/II study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in patients with hereditary angioedema (HAE). Part of the COMPACT (Clinical Studies for Optimal Management in Preventing Angioedema with Low-Volume Subcutaneous C1-inhibitor Replacement Therapy) program, the study will evaluate the pharmacokinetics, pharmacodynamics and safety of various doses of this presentation of C1-INH.
03 May 2012 CSL Behring announced today that it has initiated an international phase I/II study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in...
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Apr 18, 2012As a little girl, Kristin Prior came to view what others may have seen as out of the ordinary as normal: The slightest tap or bump would result in a severe bruise and nosebleeds came often and without warning. As a teenager and into adulthood Kristin’s menstrual periods would be long, heavy and burdensome. Often these symptoms kept her from taking part in activities with friends and family or left her worried about what she might encounter when she did.
18 Apr 2012 As a little girl, Kristin Prior came to view what others may have seen as out of the ordinary as normal: The slightest tap or bump would result in a severe bruise and nosebleeds came...
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Apr 18, 2012
Although von Willebrand disease (VWD) is the most common hereditary bleeding disorder in the United States, affecting up to 1 percent of the population, it is often misdiagnosed or under-diagnosed...
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Apr 16, 2012To mark World Hemophilia Day 2012, CSL Behring has again committed to making significant financial contributions and donations of clotting factor concentrate to the World Federation of Hemophilia (WFH) Global Alliance for Progress (GAP) program over the period of three years, beginning in 2012. The product donations will be made with medicine having a minimum shelf-life of one year. The goal of the WFH GAP program is to improve the diagnosis and treatment of hemophilia in developing countries. In 2009, CSL Behring was the first company to make such a three-year commitment to WFH. CSL Limited, parent company to CSL Behring, is committed to contributing to the economic, social and environmental well-being of its communities. As part of the agreement, CSL Behring will provide 2 million units of one or more of its various clotting factor products to the WFH each year for three years.
16 Apr 2012 To mark World Hemophilia Day 2012, CSL Behring has again committed to making significant financial contributions and donations of clotting factor concentrate to the World Federation of...
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Mar 29, 2012CSL Behring announced today the first in human dosing of recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Phase I study will investigate in healthy volunteers the safety and pharmacokinetics of rVIIa-FP in comparison to placebo.
29 Mar 2012 CSL Behring announced today the first in human dosing of recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Phase I study will investigate in...
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Mar 28, 2012Administration of albumin reduces morbidity and mortality in cirrhotic patients undergoing large-volume paracentesis due to severe ascites, according to a new meta-analysis published online today in Hepatology, the official journal of the American Association for the Study of Liver Diseases.
28 Mar 2012 Administration of albumin reduces morbidity and mortality in cirrhotic patients undergoing large-volume paracentesis due to severe ascites, according to a new meta-analysis published...
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Mar 26, 2012CSL Behring has announced that the first patient has been enrolled in the PATH study, an international clinical trial designed to evaluate the efficacy, safety, and tolerability of two different doses of subcutaneous immunoglobulin (SCIg), compared with placebo, in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
26 Mar 2012 CSL Behring has announced that the first patient has been enrolled in the PATH study, an international clinical trial designed to evaluate the efficacy, safety, and tolerability of two...
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Mar 20, 2012The study, called PROLONG-9FP, will enroll adolescents and adults (12 – 65 years) who have hemophilia B. The patient was dosed at Werlhof Institute for Hemostasis and Thrombosis in Hannover, Germany.
20 Mar 2012 CSL Behring has announced that the first patient has been dosed in a phase II/III, prospective, open-label, multi-center study designed to evaluate the safety, efficacy and...
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Mar 15, 2012The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce intraoperative bleeding and, therefore, the volume of donor blood products (e.g., fresh frozen plasma, platelets, and red blood cells) needed during complex cardiovascular surgical procedures such as aortic aneurysm surgery.
15 Mar 2012 CSL Behring announced today that the first patient has been treated as part of the REPLACE Phase III clinical trial evaluating the efficacy and safety of fibrinogen concentrate (Human)...
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Mar 8, 2012What would you do if you were frequently sick and knew that even catching a common cold could turn into a serious medical ordeal? This is a question that faces the approximately 250,000 people in the U.S. who have been diagnosed with primary immunodeficiency (PI).
08 Mar 2012 What would you do if you were frequently sick and knew that even catching a common cold could turn into a serious medical ordeal? This is a question that faces the approximately...
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Mar 6, 2012CSL Behring announced today that treatment with Berinert, C1 Esterase Inhibitor (Human) within six hours of the onset of an acute hereditary angioedema (HAE) attack provides faster symptom relief than later treatment, according to data presented at the 2012 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
06 Mar 2012 CSL Behring announced today that treatment with Berinert®, C1 Esterase Inhibitor (Human) within six hours of the onset of an acute hereditary angioedema (HAE) attack provides faster...
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Mar 4, 2012Data presented by CSL Behring today suggest that the bioavailability of immunoglobulin G (IgG) therapies is consistent when patients with primary immunodeficiencies switch from one IgG product to another by the subcutaneous route.
04 Mar 2012 Data presented by CSL Behring today suggest that the bioavailability of immunoglobulin G (IgG) therapies is consistent when patients with primary immunodeficiencies switch from one IgG...
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Mar 1, 2012CSL Behring is the recipient of a 2012 EURORDIS Award for its pioneering work in developing and manufacturing therapies used to treat rare and serious medical conditions. The global biotherapeutics company, which specializes in plasma-derived and recombinant therapies used to treat congenital bleeding disorders, immune deficiencies, hereditary angioedema and inherited respiratory disease, is a subsidiary of CSL Limited (ASX:CSL).
01 Mar 2012 CSL Behring is the recipient of a 2012 EURORDIS Award for its pioneering work in developing and manufacturing therapies used to treat rare and serious medical conditions. The global...
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Feb 24, 2012The CSL Behring rFVIII, called 'rVIII-SingleChain', is a novel molecule being studied for the treatment of hemophilia A. It is being developed by CSL Behring, in collaboration with its parent company, CSL Limited (ASX:CSL).
24 Feb 2012 CSL Behring has announced that the first patient has been screened in its recombinant coagulation single-chain factor VIII (rFVIII) trial, part of the AFFINITY clinical trial program....
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Feb 21, 2012Thought leaders from the medical community in Europe and the U.S. examined the pros and cons of using albumin in treating liver disease and sepsis, and in cardiac surgery, during CSL Behring’s Key Issues Dialogue — "Albumin in Clinical Fluid Management."
21 Feb 2012 Thought leaders from the medical community in Europe and the U.S. examined the pros and cons of using albumin in treating liver disease and sepsis, and in cardiac surgery, during CSL...
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Feb 16, 2012CSL Behring announced today that the company has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its novel recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Orphan Drug Designation is granted for the treatment and prophylaxis of bleeding episodes in patients with congenital hemophilia and inhibitors to coagulation factor VIII or IX.
16 Feb 2012 CSL Behring announced today that the company has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its novel recombinant fusion protein linking...
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Feb 15, 2012
CSL Behring announced today the four recipients of the 2012 Interlaken Leadership Awards. Now in its second year, the Interlaken Leadership Awards program recognizes scientists whose proposals are...
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Feb 6, 2012The U.S. Hereditary Angioedema Association (HAEA) announced today that the United States Senate has unanimously passed a resolution (S. Res. 286) recognizing May 16, 2012, as Hereditary Angioedema (HAE) Awareness Day.
06 Feb 2012 The U.S. Hereditary Angioedema Association (HAEA) announced today that the United States Senate has unanimously passed a resolution (S. Res. 286) recognizing May 16, 2012, as...
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Feb 2, 2012Results of the study, which were presented during an oral session at the Gesellschaft für Thrombose- und Hämostaseforschung e.V. (GTH) congress in Switzerland, showed that rIX-FP was well tolerated in all patients and lasted longer in the body, due to its prolonged half-life, compared with current Factor IX treatment options.
02 Feb 2012 CSL Behring today announced the results of a Phase I study evaluating recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP) in patients with severe hemophilia...
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Jan 12, 2012The site is located in Vienna, Austria. The prospective, open-label study will enroll adolescents and adults (12 – 65 years) who have hemophilia B.
12 Jan 2012 CSL Behring has announced that the first site has been initiated in its global phase II/III, multi-center study to evaluate the safety, efficacy and pharmacokinetics of recombinant...
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Jan 3, 2012CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for self-administration of Berinert, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute attacks of hereditary angioedema (HAE), a rare and potentially fatal genetic disorder.
03 Jan 2012 CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for self-administration of Berinert®, C1 Esterase Inhibitor (Human), a...
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Dec 2, 2011CSL Behring announced today that it has awarded a $40,000 advocacy grant to the American Plasma Users Coalition (A-PLUS) through its Local Empowerment for Advocacy Development (LEAD) program.
02 Dec 2011 CSL Behring announced today that it has awarded a $40,000 advocacy grant to the American Plasma Users Coalition (A-PLUS) through its Local Empowerment for Advocacy Development (LEAD)...
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Nov 5, 2011New findings demonstrate that treatment with C1-esterase inhibitor (C1-INH) concentrate is effective in treating acute swelling attacks in children and adolescents with type I or type II hereditary angioedema (HAE), a rare and serious genetic disorder. Study results show that the outcomes of treatment with C1-INH during acute HAE attacks in children and adolescents are comparable to the outcomes observed in adults.
05 Nov 2011 New findings demonstrate that treatment with C1-esterase inhibitor (C1-INH) concentrate is effective in treating acute swelling attacks in children and adolescents with type I or type...