Recent News Releases
For investor-related news, see our ASX releases here.
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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...
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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...
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Jul 6, 2012
UK – 27 June, 2012 – CSL Behring UK Ltd today announce the launch of the Beriplex P/N Dosing Calculator App at The General Anaesthetists in Training Annual Scientific Meeting, taking place in...
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Jun 27, 2012Data presented today from the Privigen Impact on Mobility and Autonomy (PRIMA) trial at the Peripheral Nerve Society Inflammatory Neuropathy Consortium Meeting in Rotterdam, Netherlands, suggests that treatment with Privigen® [Immune Globulin Intravenous (Human), 10% Liquid], an intravenous immunoglobulin (IVIg), may lead to improvement in function in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
27 Jun 2012 Data presented today from the Privigen Impact on Mobility and Autonomy (PRIMA) trial at the Peripheral Nerve Society Inflammatory Neuropathy Consortium Meeting in Rotterdam,...
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Jun 8, 2012CSL Behring announced today that the company has been granted orphan drug designation by the United States Food and Drug Administration for its novel recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP).
08 Jun 2012 CSL Behring announced today that the company has been granted orphan drug designation by the United States Food and Drug Administration for its novel recombinant fusion protein linking...
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May 31, 2012CSL Behring announced today that it has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen® (immune globulin intravenous [human], 10 percent liquid for intravenous administration) in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). CIDP is a rare neurological disorder of the peripheral nerves characterized by symmetrical 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.
31 May 2012 CSL Behring announced today that it has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen® (immune globulin intravenous [human], 10...
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May 29, 2012If approved by the FDA, the CSL Behring 4-factor PCC would be the first agent of its kind available in the United States.
29 May 2012 CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin...
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May 3, 2012CSL Behring announced today that it has initiated an international phase I/II study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in patients with hereditary angioedema (HAE). Part of the COMPACT (Clinical Studies for Optimal Management in Preventing Angioedema with Low-Volume Subcutaneous C1-inhibitor Replacement Therapy) program, the study will evaluate the pharmacokinetics, pharmacodynamics and safety of various doses of this presentation of C1-INH.
03 May 2012 CSL Behring announced today that it has initiated an international phase I/II study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in...
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Apr 18, 2012As a little girl, Kristin Prior came to view what others may have seen as out of the ordinary as normal: The slightest tap or bump would result in a severe bruise and nosebleeds came often and without warning. As a teenager and into adulthood Kristin’s menstrual periods would be long, heavy and burdensome. Often these symptoms kept her from taking part in activities with friends and family or left her worried about what she might encounter when she did.
18 Apr 2012 As a little girl, Kristin Prior came to view what others may have seen as out of the ordinary as normal: The slightest tap or bump would result in a severe bruise and nosebleeds came...
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Apr 18, 2012
Although von Willebrand disease (VWD) is the most common hereditary bleeding disorder in the United States, affecting up to 1 percent of the population, it is often misdiagnosed or under-diagnosed...
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Apr 16, 2012To mark World Hemophilia Day 2012, CSL Behring has again committed to making significant financial contributions and donations of clotting factor concentrate to the World Federation of Hemophilia (WFH) Global Alliance for Progress (GAP) program over the period of three years, beginning in 2012. The product donations will be made with medicine having a minimum shelf-life of one year. The goal of the WFH GAP program is to improve the diagnosis and treatment of hemophilia in developing countries. In 2009, CSL Behring was the first company to make such a three-year commitment to WFH. CSL Limited, parent company to CSL Behring, is committed to contributing to the economic, social and environmental well-being of its communities. As part of the agreement, CSL Behring will provide 2 million units of one or more of its various clotting factor products to the WFH each year for three years.
16 Apr 2012 To mark World Hemophilia Day 2012, CSL Behring has again committed to making significant financial contributions and donations of clotting factor concentrate to the World Federation of...
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Mar 29, 2012CSL Behring announced today the first in human dosing of recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Phase I study will investigate in healthy volunteers the safety and pharmacokinetics of rVIIa-FP in comparison to placebo.
29 Mar 2012 CSL Behring announced today the first in human dosing of recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Phase I study will investigate in...
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Mar 28, 2012Administration of albumin reduces morbidity and mortality in cirrhotic patients undergoing large-volume paracentesis due to severe ascites, according to a new meta-analysis published online today in Hepatology, the official journal of the American Association for the Study of Liver Diseases.
28 Mar 2012 Administration of albumin reduces morbidity and mortality in cirrhotic patients undergoing large-volume paracentesis due to severe ascites, according to a new meta-analysis published...
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Mar 26, 2012CSL Behring has announced that the first patient has been enrolled in the PATH study, an international clinical trial designed to evaluate the efficacy, safety, and tolerability of two different doses of subcutaneous immunoglobulin (SCIg), compared with placebo, in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
26 Mar 2012 CSL Behring has announced that the first patient has been enrolled in the PATH study, an international clinical trial designed to evaluate the efficacy, safety, and tolerability of two...
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Mar 20, 2012The study, called PROLONG-9FP, will enroll adolescents and adults (12 – 65 years) who have hemophilia B. The patient was dosed at Werlhof Institute for Hemostasis and Thrombosis in Hannover, Germany.
20 Mar 2012 CSL Behring has announced that the first patient has been dosed in a phase II/III, prospective, open-label, multi-center study designed to evaluate the safety, efficacy and...
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Mar 15, 2012The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce intraoperative bleeding and, therefore, the volume of donor blood products (e.g., fresh frozen plasma, platelets, and red blood cells) needed during complex cardiovascular surgical procedures such as aortic aneurysm surgery.
15 Mar 2012 CSL Behring announced today that the first patient has been treated as part of the REPLACE Phase III clinical trial evaluating the efficacy and safety of fibrinogen concentrate (Human)...
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Mar 8, 2012What would you do if you were frequently sick and knew that even catching a common cold could turn into a serious medical ordeal? This is a question that faces the approximately 250,000 people in the U.S. who have been diagnosed with primary immunodeficiency (PI).
08 Mar 2012 What would you do if you were frequently sick and knew that even catching a common cold could turn into a serious medical ordeal? This is a question that faces the approximately...
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Mar 6, 2012CSL Behring announced today that treatment with Berinert, C1 Esterase Inhibitor (Human) within six hours of the onset of an acute hereditary angioedema (HAE) attack provides faster symptom relief than later treatment, according to data presented at the 2012 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
06 Mar 2012 CSL Behring announced today that treatment with Berinert®, C1 Esterase Inhibitor (Human) within six hours of the onset of an acute hereditary angioedema (HAE) attack provides faster...
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Mar 4, 2012Data presented by CSL Behring today suggest that the bioavailability of immunoglobulin G (IgG) therapies is consistent when patients with primary immunodeficiencies switch from one IgG product to another by the subcutaneous route.
04 Mar 2012 Data presented by CSL Behring today suggest that the bioavailability of immunoglobulin G (IgG) therapies is consistent when patients with primary immunodeficiencies switch from one IgG...
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Mar 1, 2012CSL Behring is the recipient of a 2012 EURORDIS Award for its pioneering work in developing and manufacturing therapies used to treat rare and serious medical conditions. The global biotherapeutics company, which specializes in plasma-derived and recombinant therapies used to treat congenital bleeding disorders, immune deficiencies, hereditary angioedema and inherited respiratory disease, is a subsidiary of CSL Limited (ASX:CSL).
01 Mar 2012 CSL Behring is the recipient of a 2012 EURORDIS Award for its pioneering work in developing and manufacturing therapies used to treat rare and serious medical conditions. The global...
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Feb 24, 2012The CSL Behring rFVIII, called 'rVIII-SingleChain', is a novel molecule being studied for the treatment of hemophilia A. It is being developed by CSL Behring, in collaboration with its parent company, CSL Limited (ASX:CSL).
24 Feb 2012 CSL Behring has announced that the first patient has been screened in its recombinant coagulation single-chain factor VIII (rFVIII) trial, part of the AFFINITY clinical trial program....
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Feb 21, 2012Thought leaders from the medical community in Europe and the U.S. examined the pros and cons of using albumin in treating liver disease and sepsis, and in cardiac surgery, during CSL Behring’s Key Issues Dialogue — "Albumin in Clinical Fluid Management."
21 Feb 2012 Thought leaders from the medical community in Europe and the U.S. examined the pros and cons of using albumin in treating liver disease and sepsis, and in cardiac surgery, during CSL...
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Feb 16, 2012CSL Behring announced today that the company has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its novel recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Orphan Drug Designation is granted for the treatment and prophylaxis of bleeding episodes in patients with congenital hemophilia and inhibitors to coagulation factor VIII or IX.
16 Feb 2012 CSL Behring announced today that the company has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its novel recombinant fusion protein linking...
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Feb 15, 2012
CSL Behring announced today the four recipients of the 2012 Interlaken Leadership Awards. Now in its second year, the Interlaken Leadership Awards program recognizes scientists whose proposals are...
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Feb 6, 2012The U.S. Hereditary Angioedema Association (HAEA) announced today that the United States Senate has unanimously passed a resolution (S. Res. 286) recognizing May 16, 2012, as Hereditary Angioedema (HAE) Awareness Day.
06 Feb 2012 The U.S. Hereditary Angioedema Association (HAEA) announced today that the United States Senate has unanimously passed a resolution (S. Res. 286) recognizing May 16, 2012, as...
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Feb 2, 2012Results of the study, which were presented during an oral session at the Gesellschaft für Thrombose- und Hämostaseforschung e.V. (GTH) congress in Switzerland, showed that rIX-FP was well tolerated in all patients and lasted longer in the body, due to its prolonged half-life, compared with current Factor IX treatment options.
02 Feb 2012 CSL Behring today announced the results of a Phase I study evaluating recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP) in patients with severe hemophilia...
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Jan 12, 2012The site is located in Vienna, Austria. The prospective, open-label study will enroll adolescents and adults (12 – 65 years) who have hemophilia B.
12 Jan 2012 CSL Behring has announced that the first site has been initiated in its global phase II/III, multi-center study to evaluate the safety, efficacy and pharmacokinetics of recombinant...
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Jan 3, 2012CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for self-administration of Berinert, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute attacks of hereditary angioedema (HAE), a rare and potentially fatal genetic disorder.
03 Jan 2012 CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for self-administration of Berinert®, C1 Esterase Inhibitor (Human), a...
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Dec 2, 2011CSL Behring announced today that it has awarded a $40,000 advocacy grant to the American Plasma Users Coalition (A-PLUS) through its Local Empowerment for Advocacy Development (LEAD) program.
02 Dec 2011 CSL Behring announced today that it has awarded a $40,000 advocacy grant to the American Plasma Users Coalition (A-PLUS) through its Local Empowerment for Advocacy Development (LEAD)...
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Nov 5, 2011New findings demonstrate that treatment with C1-esterase inhibitor (C1-INH) concentrate is effective in treating acute swelling attacks in children and adolescents with type I or type II hereditary angioedema (HAE), a rare and serious genetic disorder. Study results show that the outcomes of treatment with C1-INH during acute HAE attacks in children and adolescents are comparable to the outcomes observed in adults.
05 Nov 2011 New findings demonstrate that treatment with C1-esterase inhibitor (C1-INH) concentrate is effective in treating acute swelling attacks in children and adolescents with type I or type...
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Nov 5, 2011C1-esterase inhibitor (C1-INH) concentrate at 20 U/kg is a safe and effective therapy for the long-term treatment of successive acute swelling attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to final data presented today at the 2011 American College of Allergy, Asthma & Immunology (ACAAI) Annual Meeting.
05 Nov 2011 C1-esterase inhibitor (C1-INH) concentrate at 20 U/kg is a safe and effective therapy for the long-term treatment of successive acute swelling attacks at any body location in patients...
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Nov 4, 2011National Jewish Health (NJH) announced that Jordan Abbott, M.D., is the recipient of the CSL Behring – National Jewish Health Fellowship in Immunology for 2011
04 Nov 2011 National Jewish Health (NJH) announced that Jordan Abbott, M.D., is the recipient of the CSL Behring – National Jewish Health Fellowship in Immunology for 2011. Funded by an...
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Oct 6, 2011CSL Behring, a global biotherapeutics company specializing in plasma-derived and recombinant therapies that does business in 27 countries, has been named Life Sciences Company of the Year by Philadelphia Business Journal and Pennsylvania Bio.
06 Oct 2011 2FRenderLink&_cid_=1255926292354&_c_=Web_Link_C">CSL Behring, a global biotherapeutics company specializing in plasma-derived and recombinant therapies that does business in 27...
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Sep 29, 2011Young people between the ages of 15 and 22 converged on Washington, D.C. this summer, eager to tell elected officials their personal stories. The stories are as varied as the towns and cities from where they hail, places like San Antonio, Pittsburgh, Des Moines and New York..
29 Sep 2011 Young people between the ages of 15 and 22 converged on Washington, D.C. this summer, eager to tell elected officials their personal stories. The stories are as varied as the towns and...
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Sep 14, 2011Every year thousands of people in the United States who suffer with rare and serious disorders such as hemophilia, hereditary angioedema, von Willebrand disease, primary immune deficiencies and inherited respiratory disease receive lifesaving therapies derived from human plasma. These conditions affect people of all ages from children to the elderly, and from all ethnic, racial and socioeconomic backgrounds.
14 Sep 2011 Every year thousands of people in the United States who suffer with rare and serious disorders such as hemophilia, hereditary angioedema, von Willebrand disease, primary immune...
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Sep 6, 2011To demonstrate its continued commitment to innovative immunoglobulin (Ig) research, CSL Behring announced today it is seeking proposals for the next round of 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 therapy in the treatment of neurological disorders.
06 Sep 2011 To demonstrate its continued commitment to innovative immunoglobulin (Ig) research, CSL Behring announced today it is seeking proposals for the next round of Interlaken Leadership...
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Aug 25, 2011CSL Behring today announced that European health authorities have approved self-administration of Berinert, a C1-esterase inhibitor (C1-INH) concentrate indicated in Europe for the treatment of acute attacks of hereditary angioedema (HAE), a rare, serious, and sometimes life-threatening genetic disorder.
25 Aug 2011 CSL Behring today announced that European health authorities have approved self-administration of Berinert®, a C1-esterase inhibitor (C1-INH) concentrate indicated in Europe for the...
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Jul 18, 2011The donation supports WFH’s progress in improving the diagnosis and treatment of bleeding disorders in developing countries through its Global Alliance for Progress (GAP) program.
18 Jul 2011 CSL Behring has donated more than 1 million international units (IU) of von Willebrand factor (VWF)/Factor VIII (FVIII) replacement medication to patients through the World Federation...
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Jun 22, 2011A chronic or rare illness can harm more than a person’s health, it can also affect the strongest of relationships.
22 Jun 2011 A chronic or rare illness can harm more than a person’s health, it can also affect the strongest of relationships. Because the ill partner isn’t feeling well, he or she may be...
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Jun 7, 2011While millions of women are experiencing symptoms that could indicate a serious bleeding disorder, nearly half of them are not discussing those symptoms with their healthcare provider, according to new survey findings.
07 Jun 2011 While millions of women are experiencing symptoms that could indicate a serious bleeding disorder, nearly half of them are not discussing those symptoms with their healthcare provider,...
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May 31, 2011CSL Behring announced today that it has been granted Orphan Drug Designations (ODD) by the European Commission for the development of its recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP), a novel therapy to treat hemophilia A and hemophilia B patients with inhibitors.
31 May 2011 CSL Behring announced today that it has been granted Orphan Drug Designations (ODD) by the European Commission for the development of its recombinant fusion protein linking coagulation...
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May 20, 2011
Advances that CSL Behring is making in developing innovative new technologies to meet the unmet therapeutic needs of patients with hemophilia A and B will be the topic of an oral presentation at...
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May 17, 2011The award was presented this evening at the NORD Partners in Progress Celebration 2011 for "new treatments brought to market for patients with rare diseases."
17 May 2011 CSL Behring, a global biotherapeutics company specializing in plasma-derived and recombinant therapies and a subsidiary of CSL Limited (ASX:CSL), is a recipient of the National...
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May 2, 2011CSL Behring today honored the achievements of six scientists with the inaugural 2011 Interlaken Leadership Awards for advancing medical research and knowledge about the potential role of immunoglobulin therapy for the treatment of neurological disorders. The total value of the six awards is estimated to be more than $1.2 million.
02 May 2011 CSL Behring today honored the achievements of six scientists with the inaugural 2011 Interlaken Leadership Awards for advancing medical research and knowledge about the potential role...
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Apr 21, 2011CSL Behring announced today that the European Commission has granted marketing authorization for Hizentra® (Human Normal Immunoglobulin), 20 percent solution for subcutaneous injection, for treating patients diagnosed with primary immunodeficiency (PI) as well as secondary immunodeficiencies. This authorization is valid for all 29 European/European Economic Area member states.
21 Apr 2011 CSL Behring announced today that the European Commission has granted marketing authorization for Hizentra® (Human Normal Immunoglobulin), 20 percent solution for subcutaneous...
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Apr 20, 2011Thought leaders from the medical, scientific and patient advocacy communities gathered in New York and London for CSL Behring's Key Issues Dialogue–Immunoglobulin to examine challenges facing patients with primary immunodeficiencies.
20 Apr 2011 in New York and London for CSL Behring's Key Issues Dialogue–Immunoglobulin to examine challenges facing patients with primary immunodeficiencies. They found common ground between...
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Apr 19, 2011CSL Behring’s capacity to produce Hizentra, a key product in its global immunoglobulin portfolio, has more than doubled following U.S. Food and Drug Administration (FDA) approval of the company’s high tech production facility in Bern, Switzerland, where Hizentra is produced.
19 Apr 2011 CSL Behring's capacity to produce Hizentra® a key product in its global immunoglobulin portfolio, has more than doubled following U.S. Food and Drug Administration (FDA) approval of...
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Apr 19, 2011For parents, trying to determine whether to take a child who is experiencing the signs of a cold to the doctor can be a regular occurrence. From runny noses to ear infections, kids can pass illnesses back and forth. The Centers for Disease Control and Prevention estimates that children have about two to nine illnesses per year, nearly double the number of colds adolescents and adults experience during the same timeframe.
19 Apr 2011 For parents, trying to determine whether to take a child who is experiencing the signs of a cold to the doctor can be a regular occurrence. From runny noses to ear infections, kids can...
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Apr 15, 2011CSL Behring, a world leader in the development of plasma-derived and recombinant therapeutics, today announced the winners of this year’s prestigious CSL Behring Prof. Heimburger Award 2011. The announcement coincides with World Hemophilia Day and reflects this year’s theme to "Be Inspired, Get Involved in Treatment for All.
15 Apr 2011 CSL Behring, a world leader in the development of plasma-derived and recombinant therapeutics, today announced the winners of this year’s prestigious CSL Behring – Prof. Heimburger...
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Mar 21, 2011Data presented by CSL Behring today suggest that treatment with higher dose Hizentra (IgPro 20) correlates with reduced risk of infection and missed school or work among patients with primary immunodeficiencies (PI). These data, presented at the 2011 American Academy of Allergy, Asthma and Immunology annual meeting, derived from two recent trials of Hizentra, one performed in the United States and one in the European Union, and aimed to show the relationship between subcutaneous IgG (SCIg) dosage and clinical outcomes.
21 Mar 2011 Data presented by CSL Behring today suggest that treatment with higher dose Hizentra® (IgPro 20) correlates with reduced risk of infection and missed school or work among patients...
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Mar 19, 2011CSL Behring today announced the development of an innovative pharmacokinetic (PK) model that allows the absorption, distribution, metabolism, and elimination of subcutaneous (SC) immunoglobulin G (IgG) following administration to be simulated with a high degree of accuracy and precision.
19 Mar 2011 CSL Behring today announced the development of an innovative pharmacokinetic (PK) model that allows the absorption, distribution, metabolism, and elimination of subcutaneous (SC)...
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Mar 2, 2011These awards honor accountable companies for openly sharing high quality information about therapies.
02 Mar 2011 CSL Behring was recognized in the 2010 Prescrire Information Awards. These awards honor accountable companies for openly sharing high quality information about therapies. Results were...
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Feb 28, 2011CSL Behring announces a special edition of its Key Issues Dialogue series released in conjunction with Rare Disease Day 2011, an international event to raise awareness of rare diseases and their impact on people’s lives. The Dialogue spanned two continents and provided a platform for sharing and exploring important information and ideas for patients, caregivers and healthcare providers.
28 Feb 2011 CSL Behring announces a special edition of its Key Issues Dialogue series released in conjunction with Rare Disease Day 2011, an international event to raise awareness of rare diseases...
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Feb 24, 2011CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, from 24 months to 30 months.
24 Feb 2011 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra®,...
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Feb 18, 2011CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact, Factor XIII Concentrate (Human), for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency. Corifact, already available for use in 12 countries throughout the world under the trade name Fibrogammin- P, is the first and only FXIII concentrate approved in the U.S.
18 Feb 2011 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact™, Factor XIII Concentrate (Human), for the routine...
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Jan 20, 2011CSL Behring has awarded advocacy grants totaling almost $100,000 to six patient organizations through the Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support the grassroots advocacy efforts of organizations committed to helping people who use plasma-derived or recombinant therapies to manage rare and serious diseases.
20 Jan 2011 CSL Behring, a global leader in the plasma-protein biotherapies industry and a subsidiary of CSL Limited (ASX:CSL), has awarded advocacy grants totaling almost $100,000 to six patient...
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Dec 1, 2010CSL Behring announced today the availability of the next generation HeliTrax System as part of a specially designed software platform for Apple’s iPhone, iPod touch, or iPad devices. This enhanced system is designed to improve therapy management for people with hemophilia A who use CSL Behring’s recombinant factor VIII (rFVIII).
01 Dec 2010 CSL Behring announced today the availability of the next generation HeliTrax® System as part of a specially designed software platform for Apple’s iPhone®, iPod touch®, or iPad™...
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Nov 17, 2010Huffing and puffing as he carried his luggage through airports at the age of 40, businessman Mike Wummer began to question the chronic shortness of breath he was experiencing at such a young age. Whether playing basketball or trumpet, skiing or glassblowing with his two sons, the active father would frequently have trouble breathing, forcing him to visit the emergency room.
17 Nov 2010 Huffing and puffing as he carried his luggage through airports at the age of 40, businessman Mike Wummer began to question the chronic shortness of breath he was experiencing at such a...
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Oct 29, 2010To demonstrate its continued commitment to innovative immunoglobulin (Ig) research, CSL Behring announced today it has created the Interlaken Leadership Awards. This global awards program will provide monetary grants to advance medical research and knowledge about the potential role of immunoglobulin therapy in the treatment of neurologic disorders.
29 Oct 2010 To demonstrate its continued commitment to innovative immunoglobulin (Ig) research, CSL Behring announced today it has created the Interlaken Leadership Awards. This global awards...
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Oct 27, 2010The FDA and EMA's most recently formed discussion group addresses blood-related drug products, and pharma companies involved in the space said they hope the agencies can agree on study designs. The result could be the avoidance of unnecessary testing replication or unnecessary diverse testing methodologies, sources said.
27 Oct 2010 The FDA and EMA's most recently formed discussion group addresses blood-related drug products, and pharma companies involved in the space said they hope the agencies can agree on study...
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Oct 18, 2010Imagine living in a world where even common germs can trigger extreme illness that won’t go away. This is the reality for nearly 10 million children and adults living with primary immunodeficiency (PI).
18 Oct 2010 Imagine living in a world where even common germs can trigger extreme illness that won’t go away. This is the reality for nearly 10 million children and adults living with primary...
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Oct 7, 2010Hizentra (IgPro20) provides primary immunodeficiency (PI) patients with a safe and effective alternative to other immunoglobulin therapies when given in equivalent doses, according to a Phase III pivotal trial data presented today at the XIVth Meeting of the European Society for Immunodeficiencies (ESID).
07 Oct 2010 Hizentra® (IgPro20) provides primary immunodeficiency (PI) patients with a safe and effective alternative to other immunoglobulin therapies when given in equivalent doses, according...
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Oct 7, 2010Privigen, the first and only 10% liquid intravenous immunoglobulin (IVIg) therapy stabilized with proline, is effective and well tolerated in patients with several primary and secondary immunodeficiencies, according to data presented today at the XIVth Meeting of the European Society for Immunodeficiencies.
07 Oct 2010 Privigen®, the first and only 10% liquid intravenous immunoglobulin (IVIg) therapy stabilized with proline, is effective and well tolerated in patients with several primary and...
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Oct 7, 2010Vivaglobin (subcutaneous immunoglobulin [IgG]) (SCIg) is an effective and safe initial therapy for treatment-naïve patients with primary immunodeficiency (PI) and may offer an attractive alternative to intravenous IgG (IVIG) therapy in the newly diagnosed, according to data presented today at the XIVth Meeting of the European Society for Immunodeficiencies.
07 Oct 2010 Vivaglobin® (subcutaneous immunoglobulin [IgG]) (SCIg) is an effective and safe initial therapy for treatment-naïve patients with primary immunodeficiency (PI) and may offer an...
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Sep 28, 2010The American Academy of Allergy, Asthma Immunology (AAAAI) and CSL Behring are pleased to announce Duane Wesemann, MD, PhD, of Brigham and Women’s Hospital, as the recipient of the 2010 Young Investigator Award.
28 Sep 2010 The American Academy of Allergy, Asthma & Immunology (AAAAI) and CSL Behring are pleased to announce Duane Wesemann, MD, PhD, of Brigham and Women’s Hospital, as the recipient of the...
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Sep 18, 2010CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months.
18 Aug 2010 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to extend the shelf life of Hizentra®,...
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Sep 14, 2010CSL Behring announces the publication of its latest Key Issues Dialogue – Hereditary Angioedema (HAE) in the US. This ongoing series brings together thought leaders from the medical science and patient advocacy communities to examine critical issues affecting people with rare and serious diseases.
14 Sep 2010 CSL Behring announces the publication of its latest Key Issues Dialogue – Hereditary Angioedema (HAE) in the US. This ongoing series brings together thought leaders from the medical...
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Jun 23, 2010CSL Behring, a global leader in the plasma-protein biotherapies industry, has awarded advocacy grants totaling almost $50,000 to four patient organizations through the Local Empowerment for Advocacy Development (LEAD) program.
23 Jun 2010 CSL Behring, a global leader in the plasma-protein biotherapies industry and a subsidiary of CSL Limited (ASX:CSL), has awarded advocacy grants totaling almost $50,000 to four patient...
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Jun 2, 2010CSL Behring Canada announced today that it has received Notice of Compliance for Berinert® (Human C1 Esterase Inhibitor). The company may now market Berinert for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) of moderate and severe intensity.
02 Jun 2010 CSL Behring Canada announced today that it has received Notice of Compliance for Berinert® (Human C1 Esterase Inhibitor). The company may now market Berinert for the treatment of...
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May 27, 2010CSL Behring announced today it has been granted national marketing authorization in Italy and Luxembourg to market Berinert for the treatment of acute hereditary angioedema (HAE) attacks in any body location. This latest authorization brings to 28 the number of countries (in Europe, Asia, North America, South America and Australia) in which Berinert is now licensed.
27 May 2010 CSL Behring announced today it has been granted national marketing authorization in Italy and Luxembourg to market Berinert® for the treatment of acute hereditary angioedema (HAE)...