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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...
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May 7, 2014Learning you have a rare, chronic medical condition can be unsettling, frustrating and downright scary. For primary immunodeficiency (PI) patient Rebecca Johnson, 33, it also made her question whether she could realize her dream of becoming a mother.
07 May 2014 Learning you have a rare, chronic medical condition can be unsettling, frustrating and downright scary. For primary immunodeficiency (PI) patient Rebecca Johnson, 33, it also made her...
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May 1, 2014CSL Behring today announced that the first patient has been enrolled in the pivotal pediatric phase III study to evaluate the efficacy, safety and pharmacokinetics of its novel investigational recombinant factor VIII single chain (rVIII-SingleChain) for the treatment of previously treated children (up to age 11 years) with severe hemophilia A. The study site for this first enrollment is Malaysia.
01 May 2014 CSL Behring today announced that the first patient has been enrolled in the pivotal pediatric phase III study to evaluate the efficacy, safety and pharmacokinetics of its novel...
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Apr 17, 2014CSL Behring announced today that the company will continue its ongoing commitment to the global coagulation disorders community with a donation of product to the World Federation of Hemophilia (WFH). The donation, provided in connection with World Hemophilia Day on April 17, supports WFH’s Global Alliance for Progress (GAP) program aimed at improving the diagnosis and treatment of bleeding disorders in developing countries.
17 Apr 2014 CSL Behring announced today that the company will continue its ongoing commitment to the global coagulation disorders community with a donation of product to the World Federation of...
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Apr 5, 2014Continuing Legacy of Strong Support for the Alpha-1 Community
05 Apr 2017 LISBON, PORTUGAL — 05 April 2017 Global biotherapeutics leader CSL Behring today announced it is presenting efficacy data in intravenous Alpha1-Proteinase Inhibitor (A1-PI) therapy...
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Mar 24, 2014People who are treating hemophilia A or von Willebrand Disease (VWD) with a CSL Behring therapy may now be eligible for financial support through the company’s My Access™ cost share program. My Access helps hemophilia A and VWD patients, who have private insurance, cover the out-of-pocket costs, up to $12,000, associated with treatment.
24 Mar 2014 People who are treating hemophilia A or von Willebrand Disease (VWD) with aCSL Behring therapy may now be eligible for financial support through the company’s My Access™ cost share...
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Mar 24, 2014Navigating the complexities of the Affordable Healthcare Act (ACA) can be challenging, particularly where patients with chronic medical disorders such as hemophilia and von Willebrand disease are concerned. CSL Behring is awarding a Local Empowerment for Advocacy Development (LEAD) grant to help bleeding disorder patients develop a clearer understanding of ACA and potential areas of concern.
24 Mar 2014 Navigating the complexities of the Affordable Healthcare Act (ACA) can be challenging, particularly where patients with chronic medical disorders such as hemophilia and von Willebrand...
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Mar 1, 2014Findings announced by CSL Behring today show that current hereditary angioedema (HAE) treatment options, such as C1 Esterase Inhibitor (C1-INH) concentrate, are allowing for greater patient satisfaction, higher rates of home treatment and a decrease in the number of hospitalizations and visits to the emergency room. HAE is a rare, potentially fatal swelling disorder caused by a deficiency of C1-INH. Until recently, only limited therapeutic options were available for patients in the U.S. with the condition. Today, HAE patients can choose from multiple options to address their condition. The 46-question online survey of physicians, which was conducted between March and June 2013, closely patterned after an initial survey conducted between October 2009 and February 2010. The data were presented at the 2014 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
01 Mar 2014 Findings announced by CSL Behring today show that current hereditary angioedema (HAE) treatment options, such as C1 Esterase Inhibitor (C1-INH) concentrate, are allowing for greater...
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Feb 28, 2014CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, Factor XIII Concentrate (Human), to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the U.S. for the routine prophylactic treatment of congenital factor XIII deficiency.
28 Feb 2013 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, Factor XIII Concentrate (Human), to include the...
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Feb 20, 2014You can tell a lot about a company and its employees by the way they give back to the community. CSL Behring, its subsidiary, CSL Plasma and their employees do just that, year-round, supporting a wide range of organizations that provide services to people in need.
20 Feb 2014 You can tell a lot about a company and its employees by the way they give back to the community. CSL Behring, its subsidiary, CSL Plasma and their employees do just that, year-round,...
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Feb 20, 2014CSL Behring today announced it has enrolled the first patient in COMPACT, an international phase III study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in patients with frequent hereditary angioedema (HAE) attacks (NCT01912456). This phase of the COMPACT program will assess the efficacy and safety of a new formulation of the CSL Behring C1-INH concentrate in preventing hereditary angioedema attacks when the therapy is administered twice weekly under the skin (i.e., subcutaneously) of patients diagnosed with HAE.
20 Feb 2014 CSL Behring today announced it has enrolled the first patient in COMPACT, an international phase III study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor...
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Dec 13, 2013
CSL Behring today announced that Kcentra® (Prothrombin Complex Concentrate [Human]) has received U.S. Food and Drug Administration (FDA) approval for an expanded indication -- urgent reversal of...
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Dec 9, 2013Data presented today by CSL Behring at the 55th Annual Meeting of the American Society of Hematology (ASH) showed Kcentra® (Prothrombin Complex Concentrate [Human]) was superior to plasma, the current standard of care in the U.S., in adult patients taking vitamin K antagonist therapy (VKA; e.g., warfarin) who required warfarin reversal prior to an urgent surgery or invasive procedure. Kcentra, the first non-activated 4-factor prothrombin complex concentrate (4F-PCC), was approved by the FDA in April 2013 for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. Kcentra is not indicated for urgent reversal of VKA anticoagulation in patients without acute major bleeding and is not indicated for use in patients on VKA therapy requiring an urgent surgery or invasive procedure as evaluated in this study.
09 Dec 2013 Data presented today by CSL Behring at the 55th Annual Meeting of the American Society of Hematology (ASH) showed Kcentra® (Prothrombin Complex Concentrate [Human]) was superior to...
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Dec 2, 2013CSL Behring’s parent company CSL Limited (ASX:CSL) reaffirms the companies’ commitment to responsible business practice and sustainable development in its new corporate responsibility report – Our Corporate Responsibility 2013. The report details CSL’s performance across key corporate responsibility priority areas for the period July 1, 2012 through June 30, 2013.
02 Dec 2013 CSL Behring’s parent company CSL Limited (ASX:CSL) reaffirms the companies’ commitment to responsible business practice and sustainable development in its new corporate...
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Nov 25, 2013CSL Behring today announced the availability of DNA1 Advanced Alpha-1 ScreeningTM (DNA1), a new test that aims to improve diagnosis of Alpha-1 Antitrypsin Deficiency (Alpha-1). Launched during Alpha-1 Awareness Month, DNA1 is the only comprehensive Alpha-1 test available that identifies known and unknown clinically relevant genetic variants to help physicians achieve an accurate diagnosis.
25 Nov 2013 CSL Behring today announced the availability of DNA1 Advanced Alpha-1 ScreeningTM (DNA1), a new test that aims to improve diagnosis of Alpha-1 Antitrypsin Deficiency (Alpha-1)....
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Nov 20, 2013Results of a Phase 2a trial of CSL112, sponsored by CSL Limited, demonstrated favorable safety and tolerability when administered to patients with stable atherothrombotic disease. The trial data for CSL112 also showed a dramatic and rapid increase in key biomarkers of reverse cholesterol transport, a process by which cholesterol is removed from arteries and transported to the liver for clearance.
20 Nov 2013 Results of a Phase 2a trial of CSL112, sponsored by CSL Limited, demonstrated favorable safety and tolerability when administered to patients with stable atherothrombotic disease. The...
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Nov 8, 2013More patients with hereditary angioedema (HAE), a rare and potentially fatal genetic disorder, are being offered and opting for self-administration therapy, according to data from a new survey being presented at the 2013 American College of Allergy, Asthma & Immunology (ACAAI) Annual Meeting. Of the HAE treatment centers surveyed in Europe, Canada and the United States, the majority (70 percent) reported that at least 50 percent of patients were now self-administering their therapy, and the HAE specialists who responded agreed that this treatment option is advantageous to patients, citing key benefits as time saved, independence and convenience.
08 Nov 2013 More patients with hereditary angioedema (HAE), a rare and potentially fatal genetic disorder, are being offered and opting for self-administration therapy, according to data from a...
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Oct 15, 2013CSL Plasma, operator of one of the largest plasma collection networks in the world and parent company CSL Behring celebrate the contributions of donor-heroes during International Plasma Awareness Week (IPAW), October 13–20. The week-long observance, which is sponsored by the Plasma Protein Therapeutics Association and its member-companies, raises global awareness of source plasma collection and increases understanding of plasma protein therapies and rare diseases.
15 Oct 2013 CSL Plasma, operator of one of the largest plasma collection networks in the world and parent company CSL Behring celebrate the contributions of donor-heroes during International...
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Oct 3, 2013People who are living with a rare and serious bleeding disorder will now have one-stop access to educational resources, financial support, and community connection programs through CSL Behring’s MySource™ program. Launched during the National Hemophilia Foundation’s (NHF) 65th Annual Meeting, MySource allows patients, caregivers and healthcare professionals to quickly and easily access CSL Behring’s patient-support resources at one online location www.MySourceCSL.com or with a one-on-one care coordinator (at 1-800-676-4266).
03 Oct 2013 People who are living with a rare and serious bleeding disorder will now have one-stop access to educational resources, financial support, and community connection programs through CSL...
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Sep 27, 2013CSL Behring announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Hizentra® (Immune Globulin Subcutaneous [Human]) for the treatment of primary immunodeficiency (PID) and for the treatment of secondary immunodeficiency (SID). Hizentra is now the first and only 20 percent subcutaneous immunoglobulin (SCIg) therapy in the world for the treatment of these conditions, both of which belong to group of rare and serious diseases of the immune system. The Japanese MHLW approval marks the first time any SCIg therapy has been approved for use in Japan.
27 Sep 2013 CSL Behring announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Hizentra® (Immune Globulin Subcutaneous [Human]) for the treatment of primary...
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Sep 27, 2013CSL 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 dosing once every two weeks (biweekly) for people diagnosed with primary immunodeficiency (PI). Hizentra, the first and only 20 percent subcutaneous immunoglobulin, received FDA approval in March 2010 as a once weekly immunoglobulin G (IgG) replacement therapy. Self-administered weekly or biweekly, Hizentra delivers consistent levels of IgG to help protect those with PI against infections.
27 Sep 2013 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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Sep 3, 2013CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a 10 g (50 mL) vial size for Hizentra®, Immune Globulin Subcutaneous (Human). Hizentra, the first and only 20 percent subcutaneous immunoglobulin therapy, keeps serum immunoglobulin G (IgG) levels consistent week to week to help protect people with primary immunodeficiency (PI) against infections. The new vial size, 10 g (50 mL), will be available in the U.S. in October.
03 Sep 2013 CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a 10 g (50 mL) vial size for Hizentra®, Immune Globulin Subcutaneous (Human). Hizentra, the...
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Aug 12, 2013CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for Kcentra™ (Prothrombin Complex Concentrate [Human]) for use in the inpatient hospital setting for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. Kcentra, the first non-activated 4-factor prothrombin complex concentrate (4F-PCC), was approved by the U.S. Food and Drug Administration (FDA) in April 2013 for this use.
12 Aug 2013 CSL Behring today announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new technology add-on payment (NTAP) for Kcentra™ (Prothrombin Complex...
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Jul 3, 2013Data presented by CSL Behring today showed clinical efficacy of a once-weekly dosing regimen of recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP). Results of the study were presented during an oral session at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
03 Jul 2013 Data presented by CSL Behring today showed clinical efficacy of a once-weekly dosing regimen of recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP). Results...
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Jul 3, 2013CSL Behring today presented a population pharmacokinetic model for recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. The model confirms earlier results from the first-in-human dose escalation trial, which demonstrated improved pharmacokinetics of rIX-FP, with prolonged half-life compared to currently available factor IX.
03 Jul 2013 CSL Behring today presented a population pharmacokinetic model for recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) at the International Society on...
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Jul 3, 2013CSL Behring today presented Phase I data of their recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) in healthy volunteers at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
03 Jul 2013 CSL Behring today presented Phase I data of their recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) in healthy volunteers at the International Society...