Recent News Releases
For investor-related news, see our ASX releases here.
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Dec 16, 2014CSL Behring announced today it has submitted a biologics license application (BLA) to the United States Food and Drug Administration (FDA) for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). Once approved by the FDA, rIX-FP (Coagulation Factor IX {Recombinant}, Albumin Fusion Protein) will provide people with hemophilia B and their physicians a long-acting treatment option with dosing intervals up to 14 days.
16 Dec 2014 CSL Behring announced today it has submitted a biologics license application (BLA) to the United States Food and Drug Administration (FDA) for the marketing authorization of its...
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Dec 8, 2014Wheezing, shortness of breath and chronic bronchitis are often associated with asthma or chronic obstructive pulmonary disease (COPD). However, they are also symptoms of a serious genetic form of emphysema called Alpha-1 Antitrypsin Deficiency, also known as Alpha-1.
08 Dec 2014 Wheezing, shortness of breath and chronic bronchitis are often associated with asthma or chronic obstructive pulmonary disease (COPD). However, they are also symptoms of a serious...
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Dec 4, 2014CSL Behring’s parent company CSL Limited (ASX:CSL) has issued its annual corporate responsibility report – “Our Corporate Responsibility 2014.” The report details the global biopharmaceutical company’s performance across key priority areas from July 1, 2013 through June 30, 2014 – recording another strong performance led by CSL Behring.
04 Dec 2014 CSL Behring’s parent company CSL Limited (ASX:CSL) has issued its annual corporate responsibility report – “Our Corporate Responsibility 2014.” The report details the global...
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Dec 4, 2014CSL Behring announced today that the European Medicines Agency (EMA) has approved the amended product labeling for Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid. The new label provides the ability to individualize treatment with flexible dosing – to administer Hizentra at intervals from daily to once every two weeks (biweekly).
04 Dec 2014 CSL Behring announced today that the European Medicines Agency (EMA) has approved the amended product labeling for Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid. The new...
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Dec 1, 2014CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex Concentrate [Human]) through September 2015 for eligible Medicare beneficiaries treated in the inpatient hospital setting. Kcentra, the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA), is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or in need of an urgent surgery or invasive procedure. Kcentra, first approved for use in the U.S. in April 2013, received its NTAP designation effective October 1, 2013.
01 Dec 2014 CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has extended the new technology add-on payment (NTAP) for Kcentra® (Prothrombin Complex...
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Nov 18, 2014Two research studies presented today at the American Heart Association Scientific Sessions in Chicago provide further understanding of the mechanisms by which CSL112, a novel formulation of apolipoprotein A-1 (apoA-1), may reduce the high incidence of early recurrent cardiovascular events seen in post MI patients. Early recurrent cardiovascular events are associated with high morbidity and mortality, and reducing early events is an important target for new therapies.
18 Nov 2014 Two research studies presented today at the American Heart Association Scientific Sessions in Chicago provide further understanding of the mechanisms by which CSL112, a novel...
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Nov 10, 2014CSL Limited today announced the launch of AEGIS-I, a Phase 2b clinical study of CSL112, a novel formulation of apolipoprotein A-I (apoA-I). Administered as a short series of weekly infusions, CSL112 is designed to rapidly remove cholesterol from the arteries and stabilize lesions at risk of rupture. This represents a new approach to reduce the high incidence of early recurrent cardiovascular events in the days and weeks following a heart attack.
10 Nov 2014 CSL Limited today announced the launch of AEGIS-I, a Phase 2b clinical study of CSL112, a novel formulation of apolipoprotein A-I (apoA-I). Administered as a short series of weekly...
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Oct 30, 2014The goal of individualized therapy in the treatment of primary immunodeficiency (PI), a serious, life-threatening and lifelong condition, is to provide patients with the best clinical outcome. Individualized therapy is now possible thanks to recent advances in the field of IgG replacement therapy, which offer increased flexibility for physicians and patients.
30 Oct 2014 The goal of individualized therapy in the treatment of primary immunodeficiency (PI), a serious, life-threatening and lifelong condition, is to provide patients with the best clinical...
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Oct 29, 2014CSL Behring announced that William McCarthy from the Western Pennsylvania Chapter of the National Hemophilia Foundation and Nicholas Cleghorn from the Bleeding Disorders Advocacy Network are the national winners of the 2014 Gettin' in the GameSM Junior National Championship (JNC) program in golf and baseball, respectively. The JNC, launched in 2002, is CSL Behring’s annual baseball and golf competition that encourages kids to remain active despite the challenges a bleeding disorder can pose, while allowing them to develop life-long connections with other members of the community.
29 Oct 2014 CSL Behring announced that William McCarthy from the Western Pennsylvania Chapter of the National Hemophilia Foundation and Nicholas Cleghorn from the Bleeding Disorders Advocacy...
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Oct 28, 2014CSL Behring announced today that its affiliate company, CSL Behring AG, of Bern, Switzerland and Enable Injections, LLC, of Franklin, Ohio have signed a long-term development agreement for a new and innovative drug delivery system intended to improve the comfort, convenience and treatment compliance for patients with rare and serious diseases.
28 Oct 2014 CSL Behring announced today that its affiliate company, CSL Behring AG, of Bern, Switzerland and Enable Injections, LLC, of Franklin, Ohio have signed a long-term development agreement...