Recent News Releases
For investor-related news, see our ASX releases here.
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Mar 17, 2015CSL Behring today announced that The Lancet has published results from a Phase III clinical study showing Kcentra® (Prothrombin Complex Concentrate [Human]) to be superior to plasma for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients needing an urgent surgery or invasive procedure. Kcentra is the first and only non-activated 4-factor prothrombin complex concentrate (4F-PCC) approved by the U.S. Food and Drug Administration (FDA) for this use and for the urgent reversal of warfarin therapy in adult patients with acute major bleeding.
17 Mar 2015 CSL Behring today announced that The Lancet has published results from a Phase III clinical study showing Kcentra® (Prothrombin Complex Concentrate [Human]) to be superior to plasma...
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Mar 9, 2015CSL Behring announced that it is partnering with Children’s Scholarship Fund Philadelphia (CSFP) to support scholarships for low-income students. CSL Behring will contribute $80,000 to fund scholarships in 2015 and 2016, enabling low-income students in grades K-8 to attend private and parochial schools that partner with CSFP.
09 Mar 2015 CSL Behring announced that it is partnering with Children's Scholarship Fund Philadelphia (CSFP) to support scholarships for low-income students. CSL Behring will contribute $80,000 to...
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Feb 26, 2015In recognition of Rare Disease Day and as part of its ongoing commitment to the global bleeding disorders community, CSL Behring announced today that it is donating 2 million international units (IUs) of protein therapies to the World Federation of Hemophilia (WFH). WFH is an international not-for- profit organization which has worked to improve the lives of people with hemophilia and other inherited bleeding disorders. The donation supports the WFH’s Global Alliance for Progress (GAP) Program aimed at improving the diagnosis and treatment of bleeding disorders in developing countries. CSL was the first biotherapies company in the world to make a multiyear commitment to WFH to aid the GAP Program with coagulation factor donations over an extended period of time, starting in 2009. Rare Disease Day, February 28, is coordinated by the European Organization for Rare Diseases (EURORDIS) and by several national alliances and patient organizations around the globe.
26 Feb 2015 In recognition of Rare Disease Day and as part of its ongoing commitment to the global bleeding disorders community, CSL Behring announced today that it is donating 2 million...
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Feb 4, 2015
04 Feb 2015 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the marketing authorization of its...
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Feb 2, 2015CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has expanded the administration options for Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, to include the ability to individualize therapy with flexible dosing – treatment at regular intervals from daily to once every two weeks (biweekly) – for people with primary immunodeficiency (PI). Self-administered subcutaneously, Hizentra delivers consistent levels of immunoglobulin G (IgG) regardless of dosing schedule. Hizentra, the first and only 20 percent subcutaneous immunoglobulin, received FDA approval in March 2010 as a once-weekly IgG replacement therapy to help protect people with PI against infections and was approved for biweekly (once every two weeks) dosing in September 2013.
02 Feb 2015 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has expanded the administration options for Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid,...
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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...