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Jul 3, 2013CSL Behring today announced that pharmacokinetic results for its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) showed improved half-life over octocog alfa (the comparator). It also demonstrated a safety and efficacy profile that supports advancement to late-stage clinical development. The data were presented at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
03 Jul 2013 CSL Behring today announced that pharmacokinetic results for its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) showed improved half-life...
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Jun 27, 2013CSL Behring today announced it will present study data from three ongoing clinical trial programs evaluating the Company’s novel recombinant factor VIIa (rVIIa-FP), VIII (rVIII-SingleChain) and IX (rIX-FP) agents for people with hemophilia A and B with and without inhibitors. The data will be presented at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam. CSL Behring is the only company pursuing longer-acting rVIIa-FP and rIX-FP candidates based on recombinant albumin, and a rVIII-SingleChain compound that has been shown to improve the stability and half-life of factor VIII (FVIII).
27 Jun 2013 CSL Behring today announced it will present study data from three ongoing clinical trial programs evaluating the Company’s novel recombinant factor VIIa (rVIIa-FP), VIII...
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Jun 4, 2013CSL Behring has dosed the first patient in Part 3 of its AFFINITY clinical trial program, which is now in phase III. AFFINITY is an open-label, non-randomized multi-center study evaluating the efficacy, safety and pharmacokinetics of its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) for the treatment of hemophilia A. The patient was dosed in Vienna, Austria and had a successful major surgery.
04 Jun 2013 CSL Behring has dosed the first patient in Part 3 of its AFFINITY clinical trial program, which is now in phase III. AFFINITY is an open-label, non-randomized multi-center study...
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Apr 29, 2013CSL Behring announced today that the U.S. Food and Drug Administration (FDA) approved Kcentra™ (Prothrombin Complex Concentrate [Human]), the first non-activated 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding. The pivotal clinical trial showed that Kcentra met all efficacy and safety endpoints, including the endpoints of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma, the most widely used agent for warfarin reversal in the United States.
29 Apr 2013 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) approved Kcentra™ (Prothrombin Complex Concentrate [Human]), the first non-activated 4-factor prothrombin...
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Apr 16, 2013CSL Behring today announced that European health authorities have approved an extended use of Berinert®, a C1-esterase inhibitor (C1-INH) concentrate, for pre-procedure prevention (short-term prophylaxis) of acute episodes of hereditary angioedema (HAE), in adult and pediatric patients undergoing medical, dental or surgical procedures. HAE is a rare, serious and sometimes life-threatening genetic disorder.
16 Apr 2013 CSL Behring today announced that European health authorities have approved an extended use of Berinert®, a C1-esterase inhibitor (C1-INH) concentrate, for pre-procedure prevention...
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Apr 4, 2013CSL Behring announced today that the European Commission has granted marketing authorization for the use of Privigen® (immune globulin intravenous [human], 10 percent liquid, for intravenous administration) in the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare neurological disorder of the peripheral nerves characterized by 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.
04 Apr 2013 CSL Behring announced today that the European Commission has granted marketing authorization for the use of Privigen® (immune globulin intravenous [human], 10 percent liquid, for...
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Feb 23, 2013New data from a CSL Behring analysis show that treatment with Berinert®, C1 Esterase Inhibitor (Human), provides significant resolution of cutaneous attacks of hereditary angioedema (HAE). The data were presented at the 2013 annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI). HAE is a rare, potentially fatal swelling disorder caused by a deficiency of C1 Esterase Inhibitor. (C1-INH) Cutaneous HAE attacks are characterized as skin edema or swelling, and often disable and disfigure the face and extremities at the time of the attack.
23 Feb 2013 New data from a CSL Behring analysis show that treatment with Berinert®, C1 Esterase Inhibitor (Human), provides significant resolution of cutaneous attacks of hereditary angioedema...
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Feb 23, 2013
CSL Behring announced the results of a cost-effectiveness analysis showing that on-demand treatment of hereditary angioedema (HAE) attacks with Berinert®, C1 Esterase Inhibitor (Human), provides...
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Feb 21, 2013CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size for Privigen®, immune globulin intravenous [human]. The new vial size will simplify preparation and administration of the product when high volumes of it are required. Privigen is approved for the treatment of patients with primary immunodeficiency (PID), a group of rare and serious diseases of the immune system, and provides effective protection against infection by assisting the body in maintaining a normal level of immunoglobulin. Privigen is also approved in the United States for chronic immune thrombocytopenic purpura (ITP) to raise platelet counts. With the addition of the 40 g vial, Privigen will be available in four sizes in the United States, including 5 g (50 mL), 10 g (100 mL) and 20 g (200 mL). The first supply of Privigen in this new vial size will be introduced in June.
21 Feb 2013 CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size for Privigen®, immune globulin intravenous [human]. The new vial...
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Feb 5, 2013When Donna Schlacht’s son, Carl, was diagnosed with primary immunodeficiency (PI) at age 1, she resolved to not let Carl see his disorder as a barrier to pursuing his dreams. Today, Carl is a professional Supercross racer, and is helping to launch the I Am A ChamPIon campaign to inspire others to achieve their goals despite the challenges of living with PI.
When Donna Schlacht’s son, Carl, was diagnosed with primary immunodeficiency (PI) at age 1, she resolved to not let Carl see his disorder as a barrier to pursuing his dreams. Today, Carl is a...
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Jan 21, 2013CSL Behring has announced that the first patient has been enrolled in the pivotal pediatric phase III study to evaluate the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) in previously treated children (up to age 11 years). The study site for this first enrollment is the Czech Republic.
21 Jan 2013 CSL Behring achieves key milestone in PROLONG-9FP program CSL Behring is currently recruiting patients for its Phase III adult and pediatric trials, the final phase of the PROLONG-9FP...
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Jan 21, 2013Treatment with albumin reduces renal impairment and mortality in cirrhotic patients with spontaneous bacterial peritonitis (SBP), one of the most common bacterial infections in this patient population, according to a new meta-analysis supported by CSL Behring and published today in Clinical Gastroenterology and Hepatology, the official clinical practice journal of the American Gastroenterological Association Institute. Albumin, a natural plasma-derived protein that expands blood plasma volume, is widely used in conjunction with large-volume paracentesis to treat tense ascites, with vasoconstrictors for type 1 hepatorenal syndrome and with antibiotics for SBP.
21 Jan 2013 Treatment with albumin reduces renal impairment and mortality in cirrhotic patients with spontaneous bacterial peritonitis (SBP), one of the most common bacterial infections in this...
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Jan 14, 2013Committed to improving the quality of life for people with rare and serious diseases, CSL Behring is calling for proposals for the 2013 Interlaken Leadership Awards. Established in 2010, this annual global awards program provides monetary grants and/or product supply to advance medical research and knowledge about the potential role of immunoglobulin (Ig) therapy in the treatment of neurological disorders.
14 Jan 2013 Committed to improving the quality of life for people with rare and serious diseases, CSL Behring is calling for proposals for the 2013 Interlaken Leadership Awards. Established in...
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Jan 2, 2013CSL Behring announced today the launch of a financial assistance program designed to cover patients’ out-of-pocket expenses for Berinert®, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute laryngeal, facial and abdominal attacks of hereditary angioedema (HAE). HAE is a rare and potentially fatal genetic disorder. Berinert Co-Pay BENefit is the most recent addition to the Berinert Expert Network (B.E.N.®), a full-service support program for healthcare providers and HAE patients and their caregivers. Berinert is available through specialty pharmacies and distributors in the United States.
02 Jan 0201 CSL Behring announced today the launch of a financial assistance program designed to cover patients’ out-of-pocket expenses for Berinert®, C1 Esterase Inhibitor (Human), a...
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Dec 19, 2012Clinical study results published today in the journal Anesthesiology showed that human fibrinogen concentrate can significantly reduce the need for blood transfusion when given as an intra-operative, targeted first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery.
19 Dec 2012 Hannover Medical School collaborates with CSL Behring to demonstrate a significant reduction in need for transfusion of blood products following aortic replacement surgery This is the...
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Dec 13, 2012CSL Behring has teamed up with Professional Supercross racer Carl Schlacht to launch www.IamaChamPIon.com. This new online resource is part of the I am a ChamPIon campaign, a partnership that aims to raise awareness of primary immunodeficiency disease (PI or PIDD) while encouraging those with the condition to pursue their dreams despite the challenges that PI can pose.
13 Dec 2012 CSL Behring has teamed up with Professional Supercross racer Carl Schlacht to launch www.IamaChamPIon.com. This new online resource is part of the I am a ChamPIon campaign, a...
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Dec 3, 2012CSL Behring’s parent company, CSL Limited (ASX:CSL), reaffirms the company’s commitment to responsible business practice and sustainable development in its fourth Corporate Responsibility Report – Our Corporate Responsibility 2012. The report details CSL’s performance across key corporate responsibility priority areas for the period July 1, 2011 through June 30, 2012.
03 Dec 2012 CSL Behring’s parent company, CSL Limited (ASX:CSL), reaffirms the company’s commitment to responsible business practice and sustainable development in its fourth Corporate...
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Oct 4, 2012A new study conducted in Japan supports the previously demonstrated safety and efficacy of Hizentra® (Immune Globulin Subcutaneous [Human]) for the treatment of primary immunodeficiency (PID). The data were presented today at the 15th Biennial Meeting of the European Society for Immunodeficiencies (ESID).v
04 Oct 2012 A new study conducted in Japan supports the previously demonstrated safety and efficacy of Hizentra® (Immune Globulin Subcutaneous [Human]) for the treatment of primary...
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Oct 4, 2012Analysis using a new economic model demonstrates that higher dosing of subcutaneous immunoglobulin therapy (SCIg) is a cost-effective alternative to intravenous IgG replacement therapy (IVIG) in patients with primary immunodeficiencies (PID).
04 Oct 2012 Analysis using a new economic model demonstrates that higher dosing of subcutaneous immunoglobulin therapy (SCIg) is a cost-effective alternative to intravenous IgG replacement therapy...
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Sep 7, 2012The German Society for Immunology (DGfI) has awarded its 2012 Avery-Landsteiner Prize to Alain Fischer, M.D., Ph.D., of Paris, France, for his milestone discoveries and treatment developments in the management of hereditary immunodeficiencies. The Prize was presented at the European Congress for Immunology in Glasgow, Scotland today.
07 Sep 2012 The German Society for Immunology (DGfI) has awarded its 2012 Avery-Landsteiner Prize to Alain Fischer, M.D., Ph.D., of Paris, France, for his milestone discoveries and treatment...
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Aug 11, 2012A high level of health-related quality of life (HRQoL) is achievable for patients managing hereditary angioedema (HAE), a rare and serious genetic disorder, when effective treatment such as C1-inhibitor (INH) concentrate is available, according to a prospective patient assessment published recently in Allergy & Asthma Proceedings, the official journal of Regional, State & Local Allergy, Asthma and Immunology Societies (RSLAAIS) and the American Association of Certified Allergists (AACA). More than half of the HAE patients participating in the assessment reported feeling somewhat or much better with the availability of C1-INH concentrate, and more than 80 percent of participants indicated a more optimistic outlook on the future.
11 Aug 2012 A high level of health-related quality of life (HRQoL) is achievable for patients managing hereditary angioedema (HAE), a rare and serious genetic disorder, when effective treatment...
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Aug 1, 2012CSL Behring announced today that it has awarded six patient advocacy organizations in the U.S. with Local Empowerment for Advocacy Development (LEAD) grants totaling nearly $70,000. LEAD grants are awarded semiannually and are intended to help local patient organizations achieve their advocacy objectives by further developing an existing initiative or developing a new one.
01 Aug 2012 KING OF PRUSSIA, PA – 01 August 2012 – CSL Behring announced today that it has awarded six patient advocacy organizations in the U.S. with Local Empowerment for Advocacy...
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Jul 24, 2012The Jeffrey Modell Foundation (JMF), in partnership with CSL Behring, has designated the Midwest Immunology Clinic in Plymouth, Minnesota as a Jeffrey Modell Diagnostic Center for Primary Immunodeficiencies (PI). The Center is headed by Ralph Shapiro, M.D. and is devoted to the diagnosis, treatment and care of people who have PI and autoimmune disorders.
24 Jul 2012 The Jeffrey Modell Foundation (JMF), in partnership with CSL Behring, has designated the Midwest Immunology Clinic in Plymouth, Minnesota as a Jeffrey Modell Diagnostic Center for...
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Jul 11, 2012
11 Jul 2012 King of Prussia, PA – 11 July 2012 –Findings of a first-of-its-kind study of women with von Willebrand disease (VWD) show that current postpartum treatment strategies do not...
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Jul 6, 2012The mobile app, for use on smart phones, is designed to assist healthcare professionals with dosage calculation when administering Hizentra (human normal immunoglobulin, SCIg).
06 Jul 2012 UK – 2 July, 2012 – CSL Behring UK Ltd today announce the launch of the Hizentra Dosing Calculator App at The British Society for Allergy and Clinical Immunology (BSACI) Annual...