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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...
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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...
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Oct 13, 2014CSL Behring and its subsidiary, CSL Plasma, join the Plasma Protein Therapeutics Association (PPTA) in saluting the contributions of plasma donors during International Plasma Awareness Week (IPAW), celebrated October 12-18.
13 Oct 2014 2014-10-13 Plasma Donors Recognized, Collection Centers On the R PLASMA DONORS RECOGNIZED DURING INTERNATIONAL PLASMA AWARENESS WEEK FOR HELPING SAVE LIVES CSL Plasma center openings...
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Oct 8, 2014CSL Behring today announced a multi-year, $450 million two-site global capacity expansion – the latest in a series of recent production expansions to meet the growing need for its lifesaving and life-improving therapies that are used to treat patients with rare and serious medical disorders around the world.
08 Oct 2014 CSL Behring today announced a multi-year, $450 million two-site global capacity expansion – the latest in a series of recent production expansions to meet the growing need for its...
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Oct 1, 2014CSL Behring announced that it is set to commence operations in its newly expanded facility now that the U.S. Food & Drug Administration (FDA) has granted approval. The expansion significantly increases plasma processing and albumin production capacity in the Kankakee, Ill. facility.
01 Oct 2014 CSL Behring announced that it is set to commence operations in its newly expanded facility now that the U.S. Food & Drug Administration (FDA) has granted approval. The expansion...
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Sep 16, 2014CSL Behring announced today that the last patient has been treated as part of the REPLACE (Randomized Evaluation of fibrinogen versus PLACEbo in complex cardiovascular surgery) Phase III clinical trial. REPLACE is the first randomized, double blinded, placebo-controlled, multicenter study in a large population of patients evaluating fibrinogen concentrate (Human) (FCH) in controlling bleeding during aortic aneurysm surgery.
16 Sep 2014 CSL Behring announced today that the last patient has been treated as part of the REPLACE (Randomized Evaluation of fibrinogen versus PLACEbo in complex cardiovascular surgery) Phase...
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Aug 18, 2014School nurses reach 98 percent of the 50,000,000 students in U.S. public schools, grades k-12, and are uniquely positioned to facilitate the early diagnosis of serious medical conditions such as primary immunodeficiency (PI).
18 Aug 2014 School nurses reach 98 percent of the 50,000,000 students in U.S. public schools, grades k-12, and are uniquely positioned to facilitate the early diagnosis of serious medical...
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Jul 30, 2014A study presented at the 2014 World Transplant Congress evaluated the safety and efficacy of CSL Behring’s C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection following kidney transplants in highly sensitized patients. C1-INH is a human protein and an important inhibitor of the complement system.
30 Jul 2014 A study presented at the 2014 World Transplant Congress evaluated the safety and efficacy of CSL Behring’s C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection...
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Jul 3, 2014A study presented at the 2014 World Transplant Congress evaluated the safety and efficacy of CSL Behring’s C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection following kidney transplants in highly sensitized patients. C1-INH is a human protein and an important inhibitor of the complement system.
30 Jul 2014 A study presented at the 2014 World Transplant Congress evaluated the safety and efficacy of CSL Behring’s C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection...
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Jun 24, 2014CSL Behring announced today that Bart C. Jacobs, M.D., Ph.D., Erasmus University Medical Center, Rotterdam, Netherlands, is the recipient of the 2014 Interlaken Leadership Awards for original research in the field of neuroimmunology. Established in 2010, this annual global awards program provides monetary grants and/or product supply for investigational use to researchers whose proposals are likely to advance innovative medical research and knowledge about the potential role of immunoglobulin (Ig) therapy in the treatment of neurological disorders.
24 Jun 2014 CSL Behring announced today that Bart C. Jacobs, M.D., Ph.D., Erasmus University Medical Center, Rotterdam, Netherlands, is the recipient of the 2014 Interlaken Leadership Awards for...
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May 20, 2014People managing primary immunodeficiency (PI) with CSL Behring’s Hizentra® (Immune Globulin Subcutaneous [Human]) may now be eligible for financial support through the Hizentra® Co-Pay Relief Program. The new program offers eligible U.S. patients up to $4,000 per year to be applied toward Hizentra co-payments, deductibles and coinsurance. Out-of-pocket therapy costs will be processed seamlessly through the electronic billing systems of specialty pharmacies and physician offices, which means no paperwork is required for the patient, pharmacist or physician.
20 May 2014 People managing primary immunodeficiency (PI) with CSL Behring’s Hizentra® (Immune Globulin Subcutaneous [Human]) may now be eligible for financial support through the Hizentra®...
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May 14, 2014As a Diamond Sponsor of HAE Day on May 16, 2014, CSL Behring is proud to continue its partnership with HAEi, the International Patient Organization for C1 Inhibitor Deficiencies, and patient organizations throughout the world. HAE, or, hereditary angioedema, is a rare, potentially fatal swelling disorder caused by a deficiency of C1-INH, a type of protein.
14 May 2014 As a Diamond Sponsor of HAE Day on May 16, 2014, CSL Behring is proud to continue its partnership with HAEi, the International Patient Organization for C1 Inhibitor Deficiencies, and...
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May 12, 2014Interim Phase II/III and III findings presented today by CSL Behring at the World Federation of Hemophilia (WFH) 2014 Congress demonstrate an improved pharmacokinetic (PK) profile of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) among hemophilia B patients of all age groups. These findings suggest an improvement in hemophilia B treatment by allowing a prolonged routine prophylaxis treatment interval of 14 days or potentially longer, compared to the current standard of two to three times per week. Data were presented during an oral session at the WFH Congress in Melbourne, Australia. CSL Behring is a subsidiary of CSL Limited (CSL: ASX), a biopharmaceutical company with headquarters in Melbourne, Australia.
12 May 2014 Interim Phase II/III and III findings presented today by CSL Behring at the World Federation of Hemophilia (WFH) 2014 Congress demonstrate an improved pharmacokinetic (PK) profile of...
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May 9, 2014CSL Limited (ASX:CSL), parent company of CSL Behring which is based in King of Prussia, PA, today opened the CSL Behring Biotechnology Manufacturing Facility in Melbourne, Australia. The new facility, located adjacent to the site’s manufacturing plant for plasma products, is the centerpiece of CSL’s $250 million expansion at its Broadmeadows site and will play an increasingly important role in the company’s global operations, particularly in the late-stage development of new types of hemophilia products. It is one of the largest and most advanced facilities of its kind in the world and will produce novel recombinant therapies on a large scale for international clinical trials.
09 May 2014 • Leading-edge science at the core of $250 million expansion to drive long-term growth in promising bleeding disorders portfolio • CSL Behring to commercialize therapies produced...