Global

News Release Archive

17 August 2009
Helixate FS Receives FDA Approval for Routine Prophylaxis in Children with Hemophilia A
CSL Behring announced today that Helixate® FS, Antihemophilic Factor (Recombinant), has been approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis in children with hemophilia A who are 16 years old or younger and do not have pre-existing joint damage. This new indication was granted by the FDA after determining Helixate FS is safe and effective for routine prophylaxis, which can reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A. More.

11 March 2009
CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP™
CSL Behring has been informed by the U.S. Food and Drug Administration (FDA) that because RiaSTAP™ is the first FDA-approved treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, the company is entitled to seven years of orphan-drug exclusivity. RiaSTAP was approved by the FDA in January and is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Approval was based on a pivotal phase II prospective, open-label pharmacokinetic (PK) and safety study using maximum clot firmness as a surrogate endpoint for hemostatic efficacy. More.

16 January 2009
CSL Behring Receives FDA Approval of RiaSTAP™, First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for RiaSTAP™, the first and only treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Congenital fibrinogen deficiency is a rare, potentially life-threatening bleeding disorder that affects an estimated one person per million, with an estimated prevalence in the U.S. of approximately 300 patients. RiaSTAP is not indicated to treat dysfibrinogenemia. More.

11 December 2008
CSL Behring Launches Voice2Voice™ Vivaglobin® Advocacy Program for New Patients and Caregivers
CSL Behring, a worldwide leader in developing immunoglobulin therapies, announced today the launch of Voice2Voice™, a consumer outreach program offering peer-to-peer support to primary immunodeficiency (PI) patients and caregivers. The program will offer assistance exclusively to new patients as they begin at-home use of Vivaglobin® (Immune Globulin Subcutaneous, Human), the first and only U.S. Food and Drug Administration-approved subcutaneous immunoglobulin (Ig) for treatment of patients with primary immunodeficiency. More.

09 December 2008
CSL Behring Awards Second Round of LEAD Grants in Support of Patient Group Advocacy Efforts
CSL Behring, a global leader in the plasma-protein biotherapies industry, announces the awarding of five grants totaling more than $65,000 to patient advocacy organizations in the United States. These five grants represent the second round of semi-annual awards in the company's Local Empowerment for Advocacy Development (LEAD) program. To date, the company has awarded more than $150,000 in grants through the LEAD program. More.

19 November 2008
CSL Behring Launches GameFaces™ Program at National Hemophilia Foundation Annual Meeting
CSL Behring announced today it launched the first challenge of GamesFaces™, a family-oriented online initiative for patients with hemophilia A, at the 60th Annual Meeting of the National Hemophilia Foundation (NHF). GameFaces is designed to encourage real-life physical activity through a series of three customized challenges based on the individual’s age, disease severity and current level of physical activity. Participants can now log on to the program website at www.HFSGameFaces.com, create their GameFaces character and begin the first challenge, which will run from today through January 10, 2009. More.

01 October 2008
Moms Raise "Red Flag" about the Dangers of Widely Undiagnosed Bleeding Disorder
National Campaign Highlights Signs, Symptoms, Impact on Families of von Willebrand Disease. A group of mothers with VWD have joined together to focus attention on the need for more communication between mothers and their children about signs, symptoms and potentially severe health consequences of this disease. More.

30 September 2008
CSL Behring Initiating Next Round of LEAD Grants to Support Patient Advocacy Efforts
CSL Behring, a global leader in the plasma protein biotherapeutics industry, is soliciting grants to support patient access to care through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program is committed to funding grassroots advocacy efforts in the United States by providing grants to patient organizations dedicated to helping people with rare diseases who use plasma-derived or recombinant therapies to manage their conditions. More.

25 September 2008
Data Published in Journal of Clinical Immunology Show Privigen™ Demonstrates Effectiveness and Tolerability in Patients with Primary Immunodeficiencies
New L-Proline Stabilized Immune Globulin Intravenous (Human) 10 Percent Liquid can be stored at room temperature, offering convenience to healthcare professionals More.

22 August 2008
CSL Behring’s Innovative HeliTraxSM System
Hemophilia A patients who use Helixate® FS, Antihemophilic Factor (Recombinant), and their treatment providers are now tracking treatment progress in real time, thanks to the HeliTraxSM System, a state-of-the-art wireless Internet-based data management system recently introduced by CSL Behring. More.

18 August 2008
CSL Behring Provides $1.2M Grant for World's First Study of Postpartum Women with VWD, Common Bleeding Disorder
CSL Behring is providing a $1.2 million grant to fund a first-of-its kind, nationwide study that when completed could serve as the basis for determining optimal prophylaxis treatment for postpartum women with von Willebrand disease (VWD). Investigators anticipate that the study results will produce a better understanding of the physiology of VWD in the postpartum period, whether treatment is needed and, if so, for how long. More.

21 July 2008
CSL Behring Submits BLA Requesting Approval of Human Fibrinogen Concentrate for the Treatment of Congenital Bleeding
CSL Behring announced today that it has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval to market its human fibrinogen concentrate in the United States for the treatment of congenital fibrinogen deficiency, a rare bleeding disorder resulting from deficiency of fibrinogen. More.

25 June 2008
CSL Behring Awards LEAD Grants to Support Patient Group Advocacy Efforts
CSL Behring announced it has recently awarded seven grants totaling more than $90,000 to patient advocacy organizations in the United States. The seven grants represent the first round of awards in the company's Local Empowerment for Advocacy Development (LEAD) program. CSL Behring is a global leader in the plasma protein biotherapeutics industry. LEAD grants support grassroots advocacy efforts by organizations committed to helping people with rare diseases who use plasma-derived and recombinant therapies to manage their health conditions. CSL Behring awards LEAD grants semiannually. More.

03 June 2008
CSL Behring Study Shows Extended Half-life Recombinant VIIa Leads to Longer Biologic Activity
CSL Behring today presented results of a pre-clinical study that not only demonstrates the feasibility of genetically fusing factor VIIa to human albumin, but that this therapeutic protein with a prolonged half-life can lead to a longer biologic effect. More.

03 June 2008
CSL Behring Awards Global Grants to Next Generation of Coagulation Researchers
CSL Behring, a global leader in the protein biotherapeutics industry, today awarded CSL Behring - Prof. Heimburger Award grants to five young medical researchers at the Hemophilia 2008 World Congress of the World Federation of Hemophilia (WFH). More.

17 May 2008
Melissa Biggs, Fashion Designer and Former Baywatch Actress, Teams with CSL Behring to Raise Awareness of Alpha-1 Antitrypsin Deficiency, a Commonly Misdiagnosed Respiratory Disease
Melissa Biggs, a fashion designer and actress who appeared on Baywatch was recently named spokesperson for an education campaign on behalf of CSL Behring, and is urging Americans to get tested for alpha1 antitrypsin (AAT) deficiency after her own diagnosis with the condition in 2005. More.

17 April 2008
CSL Behring Submits NDS to Health Canada Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
CSL Behring has filed a new drug submission (NDS) with Health Canada seeking approval to market its C1-esterase inhibitor concentrate in Canada for the treatment of hereditary angioedema (HAE), a rare and serious genetic disorder. The submission is based on the recently completed phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), the largest HAE trial ever conducted, that studied the efficacy of pasteurized C1-INH concentrate. More.

01 April 2008
CSL Behring Signs Agreements with Canadian Blood Services and Héma-Québec to Supply Life-Saving Therapies
CSL Behring Canada, Inc. today announced that Canadian Blood Services, and Héma-Québec, have each awarded the company contracts to supply Helixate® FS ( Antihemophilic Factor [Recombinant]), Humate® P (Antihemophilic factor / von Willebrand Factor Complex [Human], Dried, Pasteurized), Privigen (Immune Globulin Intravenous [Human]), Vivaglobin® (Immune Globulin Subcutaneous [Human]) and other plasma-derived products. These products are used for the treatment of conditions such as hemophilia, von Willebrand Disease, primary immunodeficiency as well as other serious conditions. More.

18 March 2008
C1-Esterase Inhibitor Concentrate Rapidly Relieves Abdominal and Facial Attacks in Patients with Hereditary Angioedema, According to Pivotal Study
C1-esterase inhibitor (C1-INH) concentrate is a safe and effective therapy that rapidly relieves acute abdominal and facial swelling attacks in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the American Academy of Allergy, Asthma & Immunology (AAAAI) 64th Annual Meeting. Results from the prospective, double-blind International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T. 1), the largest HAE study ever conducted, showed patients receiving C1-INH concentrate had a median time to symptom relief of 30 minutes, versus 90 minutes for patients receiving placebo. Additionally, interim results from I.M.P.A.C.T. 2, also presented at AAAAI, demonstrated for the first time C1-INH replacement therapy’s effectiveness in rapidly relieving HAE attacks in peripheral body locations, such as the hands and feet. More.

17 March 2008
Study Shows Privigen™10% Liquid Immunoglobulin Preparation for Intravenous Use, Is an Effective Replacement Therapy in Patients with Primary Immune Deficiencies
CSL Behring presented data today on the pharmacokinetic properties of its new immune globulin intravenous (human) 10% product, Privigen™. Researchers found that Privigen leads to immunoglobulin G (IgG) pharmacokinetic characteristics and specific antibody levels equivalent to those described for other intravenous immunoglobulin (IVIg) preparations. The study was presented at the American Academy of Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, U.S. More.

17 March 2008
L-Proline Stabilized Immune Globulin Intravenous (Human) 10% Liquid, Privigen™, Demonstrates Good Tolerability at High Infusion Rates
CSL Behring announced data today from a study that demonstrates its new liquid immune globulin intravenous (human) 10% product (Privigen™), is well-tolerated in patients with Primary Immune Deficiencies (PI); a group of predominantly genetic disorders that cause a malfunction in part or all of the immune system. New data from an additional study also showed that Privigen is well-tolerated when administered at high infusion rates. Both studies were presented at the American Academy of Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, U.S. More.

06 March 2008
CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
CSL Behring has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval to market its C1-esterase inhibitor concentrate in the United States for the treatment of hereditary angioedema (HAE), a rare and serious genetic disorder. The submission is based on the recently completed phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), the largest HAE trial ever, that studied the efficacy of pasteurized C1-INH concentrate. More.

29 February 2008
NHLBI Issues First U.S. von Willebrand Disease Clinical Practice Guidelines
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health, today issued the first clinical guidelines in the United States for the diagnosis and management of von Willebrand Disease (VWD), the most common inherited bleeding disorder. The guidelines include recommendations on screening, diagnosis, disease management, and directions for future research. An extensive article on the guidelines is published online Feb. 29 in the journal Haemophilia. More.

20 February 2008
CSL Behring Launches LEAD Program to Support Patient Group Advocacy Efforts
CSL Behring, a global leader in the plasma protein biotherapeutics industry, is launching a new program to support patient organizations’ grassroots advocacy efforts in the United States. Called Local Empowerment for Advocacy Development, or LEAD, the program will make grants available to groups of patients who have rare diseases and who use plasma-derived and recombinant therapies to manage their conditions. The program, which is the latest initiative in CSL Behring’s continued commitment to patient advocacy, includes two initiatives: LEAD Grants and Raise Your Voice!, a youth-focused advocacy training program. More.

21 December 2007
CSL Behring's Helixate® FS Now Available in 2000 IU Vial Size to Improve Patient Convenience, Encourage Compliance
CSL Behring today announced that Helixate® FS, its advanced recombinant FVIII (rFVIII) product for the treatment of hemophilia A, is now available in the United States in a new 2000 IU (international unit) vial size. For patients requiring high doses of Helixate FS, the 2000 IU vial size reduces reconstitution time by eliminating the need to mix and pool multiple vials. More.

19 December 2007
CSL Behring Expands into Middle East Market with Haemate® P
CSL Behring today announced that Iran’s Ministry of Health and Medical Education (MOHME) has granted rights to the company to distribute Haemate P on an exclusive basis throughout Iran, beginning immediately. More.

10 December 2007
Preclinical Studies Show Promise for Novel Antibody Therapy to Treat Acute Myeloid Leukemia (AML)
CSL Limited, Australia’s leading biopharmaceutical company, has today presented data at the American Society of Hematology (ASH) 49th annual meeting, which demonstrate the promising pre-clinical activity of a novel monoclonal antibody, in the potential treatment of acute myeloid leukemia (AML). More.

05 December 2007
CSL Behring study in animal models shows feasibility of developing a half-life extended recombinant FVIIa that retains biologic activity
CSL Behring today announced the results of a pre-clinical study that show for the first time it is feasible to genetically fuse Factor VIIa (FVIIa) to human albumin, prolonging the half-life of this therapeutic protein while retaining its biologic activity. In the study, which was presented at the American Society of Hematology 49th Annual Meeting and Exposition, the half-life of recombinant VIIa–albumin fusion protein (rVIIa-FP) was shown to be extended 6-to-9 fold compared to wild type rFVIIa. Additionally, rVIIa-FP demonstrated a biologic activity comparable to wild type rFVIIa. More.

26 November 2007
CSL Behring Reaches Primary Endpoint in Clinical Study of C1-INH for Treatment of Hereditary Angioedema
CSL Behring announced today that it has reached the primary endpoint of a Phase III clinical trial of human pasteurized C1-inhibitor (C1-INH) concentrate to treat patients with hereditary angioedema (HAE), a rare genetic disorder that can lead to painful and sometimes life-threatening attacks of edema (swelling) of the face, airway, abdomen, and extremities. More.

14 November 2007
Study Shows Need to Test Greater Number of COPD and Asthma Patients for Underdiagnosed Pulmonary Disease
A new study finds that a higher than expected number of COPD and severe asthma patients had abnormal low levels of alpha-1 antitrypsin (AAT), suggesting that need for broader criteria for AAT deficiency testing. AAT deficiency, also known as Alpha-1, is a widely undiagnosed hereditary disorder that is usually fatal in its severe form. More.

09 November 2007
L-Proline Stabilizer Used in the Intravenous Immunoglobulin Product Privigen® Shows No Neurological Side Effects Compared with Currently Used Stabilizers
CSL Behring announced new data today that demonstrates that L-proline causes no neurological effects, including convulsive behaviour and spatial learning and memory, even at high doses, when compared with glycine, which is used in many current intravenous immunoglobulin (IVIg) products. L-proline is used as stabilizer in the new Immune Globulin Intravenous (human) 10% product (Privigen®). The data were presented at the American Congress of Allergy, Asthma and Immunology (ACAAI) in Dallas, Texas. More.

09 November 2007
New Hope in Immunodeficiency Treatment for Improved Tolerability and Convenience in the use of Immune Globulin Intravenous (Human) 10% Liquid (Privigen®)
CSL Behring today announced data on the use of L-proline as a new single stabilizer for Immune Globulin Intravenous (Human) 10% Liquid (Privigenâ). Researchers found that the use of L-proline, a naturally occurring amino-acid, inhibited dimer formation more efficiently when compared with other additives like glycine, used as a stabilizer in conventional immunoglobulin products. In addition, the formulation with L-proline was found to prevent aggregation. The data were presented today at the American Congress of Allergy, Asthma and Immunology (ACAAI) in Dallas, Texas. More.

12 October 2007
CSL Behring Completes Enrollment of Phase III Clinical Study of C1 Inhibitor in Treating Hereditary Angioedema
CSL Behring announced today that it has completed patient enrollment of a Phase III clinical trial of human pasteurized C1-inhibitor (C1-INH) concentrate to treat patients with hereditary angioedema (HAE). More.

01 August 2007
CSL to Build High-Speed Syringe Fill Line at its Kankakee (Il) Facility
CSL Behring today announced plans to invest $15 million to expand its manufacturing facility here by adding a high-speed, single-dose syringe filling line. Plans call for the line to be operational in 2010, when the company intends to contract with its sister company, CSL Biotherapies, to provide filling and packaging services for seasonal influenza vaccine. More.

27 July 2007
CSL Behring Announces FDA Approval of PrivigenTM—First Proline-Stabilized 10 Percent Liquid IVIg
CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for PrivigenTM [Immune Globulin Intravenous (Human), 10% Liquid], an intravenous immunoglobulin (IVIg) for treating patients diagnosed with primary immunodeficiency (PI). Privigen is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding. More.

13 July 2007
CSL Behring Completes Enrollment for Phase III Registration Trial of Next Generation of Subcutaneous Immunoglobulin
CSL Behring announced today that it has completed patient enrollment for a Phase III clinical trial of a 20 percent formulation of subcutaneous immunoglobulin (SCIg) to treat patients with primary immunodeficiency (PI) who require immune globulin replacement therapy. The study will assess the efficacy, tolerability, safety and pharmacokinetics of SCIg stabilized with proline (IgPro20) in subjects with PI. The open-label registration trial incorporates 13 sites across the United States, with 54 patients now enrolled. More.

12 July 2007
CSL Behring completes enrollment for Phase III registration trial of next generation of subcutaneous immunoglobulin
CSL Behring announced today that it has completed patient enrollment for a Phase III clinical trial of a 20 percent formulation of subcutaneous immunoglobulin (SCIg) to treat patients with primary immune deficiency (PI) who require immunoglobulin replacement therapy. The study will assess the efficacy, tolerability, safety and pharmacokinetics of SCIg stabilized with proline (IgPro20) in subjects with PI. A multicenter, open-label, registration trial, the study incorporates 13 sites across the United States, with 54 patients now enrolled. More.

10 July 2007
Beriplex® P/N Provides Fast, Predictable and Safe Anti-coagulation Reversal, According to Study
Beriplex® P/N, a human prothrombin complex concentrate (PCC), is highly effective and safe in the emergency reversal of anti-coagulation, according to data presented today at the International Society on Thrombosis and Haemostasis (ISTH) XXIst Congress. The data showed Beriplex P/N rapidly and safely increases plasma levels of essential coagulation factors II, VII, IX, and X and anticoagulant inhibitors Protein C and Protein S prior to emergency interventions or to treat acute bleeding. More.

09 July 2007
CSL Behring Makes Annual Start-Up Grants Available to Next Generation of Coagulation Researchers
CSL Behring, a global leader in the protein biotherapeutics industry, announced today at the International Society on Thrombosis and Haemostasis (ISTH) XXIst Congress that it will award five annual grants to support new research projects in the area of coagulation. The start-up grants of 20,000 euros each ($26,780 U.S) will be awarded to young medical researchers for preclinical and/or clinical coagulation projects based on the scientific merit of their work. More.

29 June 2007
Immune Deficiency Foundation Applauds Legislation to Improve Patient and Provider Access to Immunoglobulin Products
The Immune Deficiency Foundation (IDF) applauds Congressman Kevin Brady (R, TX) who introduced H.R. 2914, known as the Medicare IVIG Access Act of 2007. With bipartisan support, the bill seeks adequate reimbursement for Intravenous Immunoglobulin (IVIG) products and accompanying care in the management of patients with primary immunodeficiency diseases (PIDD) and other serious conditions that require IVIG therapy. More.

18 June 2007
CSL Behring Foundation Awards 10 Grants Totaling $487,000 to Benefit Bleeding Disorders Community
The CSL Behring Foundation for Research and Advancement of Patient Health has awarded more than $487,000 in funding for programs designed to benefit the bleeding disorders community. The grants will support a range of initiatives, including research projects and programs developed to educate and support patients. More.

18 May 2007
VITAL Program Launched to Educate Healthcare Providers and Patients On Administration of Subcutaneous Immunoglobulin Therapy
CSL Behring, a worldwide leader in developing subcutaneous immunoglobulin therapies, announced today the launch of a new program to educate healthcare providers and primary immunodeficiency (PI) patients on the proper technique for administering subcutaneous immunoglobulin therapy. The program, named VITAL™, an acronym for Vivaglobin Integrated Training And Learning, is being introduced to support the at-home use of Vivaglobin® (Immune Globulin Subcutaneous, Human), the first and only U.S. Food and Drug Administration-approved subcutaneous immunoglobulin (Ig) for treatment of patients with primary immunodeficiency. Vivaglobin was approved by the FDA on January 9, 2006. More.

30 April 2007
Humate-P® Approved to Prevent Excessive Bleeding in Patients with von Willebrand Disease Undergoing Surgery
Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex [Human]), CSL Behring’s factor replacement therapy for the treatment of hemophilia A and von Willebrand disease (VWD), has been approved by the U.S. Food and Drug Administration (FDA) to prevent excessive bleeding during and after surgery, in patients with severe VWD and mild to moderate VWD where the use of desmopressin is known or suspected to be inadequate. The new indication approval follows the results of two separate clinical studies – one in Europe, another in the United States – that demonstrate the hemostatic efficacy and safety of Humate-P for VWD patients undergoing major, minor and oral surgical procedures. More.

02 April 2007
FDA Approves Rhophylac® for the Treatment of Immune Thrombocytopenic Purpura (ITP)
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for an additional indication for Rhophylac Rh0(D) (Immune Globulin Intravenous [Human]), an anti-D Rh immunoglobulin (Ig). The additional indication is for the treatment of immune thrombocytopenic purpura (ITP). Administered intravenously, Rhophylac is indicated to raise platelet counts in Rh0(D)-positive, non-splenectomized adult patients with chronic ITP. Having established efficacy and safety in over 10 years of use for other indications, Rhophylac offers high value pricing to help healthcare practitioners manage costs. More.

26 March 2007
CSL Therapy That Mimics "Good" Cholesterol May Reduce Plaque Volume in Coronary Arteries
CSL Limited today announced results from a study published in the Journal of the American Medical Association that suggest infusions of a novel new drug, CSL-111, to acutely raise HDL ("good" cholesterol) levels, may reduce the amount of plaque in the coronary arteries of patients with a recent episode of acute coronary syndrome (ACS). More.

07 March 2007
CSL Behring launches new online resource for patients with Hereditary Angioedema, a rare and serious disorder
Patients with a rare disease called Hereditary Angioedema (HAE)—and their doctors—can now find comprehensive information about the condition on a new website, www.AllAboutHAE.com, launched today by CSL Behring. The site, which is designed in two sections—one for patients and the other for physicians—presents an array of features. More.

27 February 2007
Study Shows Undiagnosed Hereditary Angioedema Can Lead to Unnecessary Surgeries, Testing in Patients with Abdominal Pain
A chart review conducted by researchers at the Institute for Asthma and Allergy showed that hereditary angioedema (HAE) patients who present only with recurrent severe abdominal pain frequently undergo unnecessary surgeries and diagnostic tests prior to diagnosis. The data were presented today at the 63rd Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI). More.

27 February 2007
Study Finds C1-Inhibitor Concentrate is Safe and Effective in Treating Skin Swelling in Patients with Hereditary Angioedema
C1-inhibitor (C1-INH) concentrate is highly effective and safe in treating skin swelling in patients with hereditary angioedema (HAE), according to data presented today at the American Academy of Allergy, Asthma & Immunology (AAAAI) 63rd Annual Meeting. According to the study, relief of symptoms occurred in all treated attacks after 1.3 hours (+/- 1.4 hours) in the mean after receiving C1-INH concentrate. In all untreated attacks, the mean time to relief of symptoms was 60 hours (+/- 26.4). More.

20 February 2007
CSL Behring’s Helixate® FS and Mix2VialTM Now Packaged Together to Optimize Patient Safety and Convenience
CSL Behring has begun packaging Helixate® FS, its advanced recombinant FVIII (rFVIII) factor product for the treatment of hemophilia A, with Mix2Vial™, its needle-free transfer device. The new packaging was developed in response to comprehensive market research of customers and to meet the latest Occupational Safety and Health Administration (OSHA) requirements. More.

01 February 2007
CSL Behring and Bayer Extend Agreement
CSL Behring announced today that it has reached an agreement with Bayer HealthCare LLC to continue the supply and distribution of an important therapy for the treatment of hemophilia A. More.

08 January 2007
CSL Behring Reports Progress on Global Implementation of Name Change
The renaming program, announced by CSL Behring's parent organization, CSL Limited, last year, will present a consistent and compelling view of the company operating in new and established markets around the world. More.

19 December 2006
ZLB Behring obtains Notice of Compliance for Sandoglobulin® NF Liquid for use in the treatment of adult and pediatric patients with primary immune deficiency (PI) or secondary immune deficiency (SI) who require immunoglobulin replacement therapy
ZLB Behring today announced that Health Canada has granted the company authorization to market Sandoglobulin® NF Liquid throughout Canada. Marketing will be accomplished by ZLB Behring Canada, Inc. Sandoglobulin® NF Liquid (Immune Globulin (Human)), which is administered intravenously, is indicated for the treatment of adult and pediatric patients who have conditions known as primary immune deficiency (PI) or secondary immune deficiency (SI), both of which are rare and life-threatening. Authorization was granted on November 3, 2006. More.

18 December 2006
ZLB Behring Completes Purchase of CytoGam® Immunoglobulin Therapy From MedImmune
ZLB Behring, a global leader in the plasma protein biotherapeutics industry and subsidiary of CSL Ltd. (ASX: CSL), today announced it has completed its purchase of CytoGam® (cytomegalovirus immunoglobulin intravenous (human)) and related assets from MedImmune, Inc. More.

16 November 2006
ZLB Behring Foundation Calls for Grant Applications
The ZLB Behring Foundation for Research and Advancement of Patient Health today announced that it is now accepting grant applications for programs designed to benefit the bleeding disorders community in the United States. At regular intervals throughout the year, the Foundation awards grants to qualifying organizations as a means of supporting clinical research and community-based patient programs. More.

08 November 2006
ZLB Behring Buys Cytogam® Immunoglobulin Therapy Used In Organ Transplants
ZLB Behring, a global leader in the plasma protein biotherapeutics industry and subsidiary of CSL Ltd. (ASX: CSL), today announced it has reached an agreement with MedImmune, Inc. to acquire Cytogam® (cytomegalovirus immunoglobulin intravenous (human)) and related assets. More.

11 October 2006
Hemophilia & Thrombosis Research Society Receives Funding from ZLB Behring To Support Mentored Research Awards
The Hemophilia & Thrombosis Research Society (HTRS) has received an unrestricted educational grant from ZLB Behring to help financially support the Society’s Mentored Research Awards. More.

18 September 2006
ZLB Behring Names Robert D. Lefebvre, Ronan W. Gannon, Garrett E. Bergman, M.D., to Top U.S. Management Posts
ZLB Behring has announced the appointment of Robert D. Lefebvre as Vice-President, General Manager, U.S. Commercial Operations. A seasoned pharmaceutical executive with over 25 years of diverse international business experience, Mr. Lefebvre is responsible for all business operations and general management accountability for all U.S. Commercial Operations at ZLB Behring, a top-ranked biopharmaceutical company specializing in plasma therapeutics. More.

12 September 2006
VIRTUE, Largest Clinical Trial of Subcutaneous Immunoglobulin Therapy, Opens to Primary Immunodeficiency Patients Across the U.S.
ZLB Behring has announced the launch of the VIRTUE Trial, a Phase IV clinical trial of the study medication Vivaglobin® (Immune Globulin Subcutaneous, Human), the first and only U.S. Food and Drug Administration-approved subcutaneous immunoglobulin (Ig) treatment for patients with primary immunodeficiency (PI). More.

22 June 2006
ZLB Behring Foundation Calls for Grant Applications
The ZLB Behring Foundation for Research and Advancement of Patient Health today announced that it is accepting grant applications for programs designed to benefit the bleeding disorders community in the United States. The Foundation awards grants at regular intervals throughout the year and supports both clinical research and community-based patient programs. More.

05 June 2006
ZLB Behring Foundation Awards Grants to Benefit Bleeding Disorders Community
The ZLB Behring Foundation for Research and Advancement of Patient Health has recently awarded funding for programs designed to benefit the bleeding disorders community. The Foundation awards grants at regular intervals throughout the year. In this cycle, nine recipients received awards. The grants support a range of initiatives, such as those that support and educate specific patient populations to research on the genetic aspect of hemophilia. More.

25 May 2006
Jeffrey Modell Foundation Opens Diagnostic Center for Primary Immunodeficiencies at Rainbow Babies and Children’s Hospital
The Jeffrey Modell Foundation (JMF), in partnership with ZLB Behring, opened the Jeffrey Modell Diagnostic Center for Primary Immunodeficiencies (PI) at Rainbow Babies and Children's Hospital today. The center is housed within the department of allergy and immunology at the hospital, and is headed by Melvin Berger, M.D. More.

23 May 2006
New International Study Group Seeks to Set Standards for Prevention, Treatment of Bleeding in Patients with von Willebrand Disease (VWD)
The von Willebrand Disease Prophylaxis Network, an international study group made up of leading bleeding disorder experts from more than 70 centers around the world, today announced the start of a study examining the use and effect of prophylactic therapy in von Willebrand disease (VWD) patients who have a history of spontaneous bleeding events. More.

22 May 2006
First International Census on von Willebrand Disease (VWD): 77 Percent of Patients with Severe Type 3 VWD Experience Significant Bleeding-Related Events
More than three-fourths of patients with Type 3 von Willebrand disease (VWD), the most severe form of the most common hereditary bleeding disorder in the world, had bleeding events in the past year that required treatment. More.

18 April 2006
State-of-the-Art ZLB Behring Plant Licensed by the FDA
ZLB Behring today announced that it has been granted a license by the U.S. Food and Drug Administration (FDA) to produce Alpha-1 Proteinase Inhibitor (Human), Zemaira®, in a new facility in its Kankakee, Illinois, manufacturing complex. More.

06 March 2006
Phase III Clinical Study Shows Vivaglobin®, a New Subcutaneous Immunoglobulin, Is Safe and Effective In Treating Patients With Primary Immunodeficiency
Data from a Phase III clinical research study, presented today at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) in Miami Beach, Florida, demonstrate the safety and efficacy of new Vivaglobin® (Immune Globulin Subcutaneous [Human]), an immunoglobulin replacement therapy for treating patients with primary immunodeficiency (PI). Vivaglobin recently became the first and only Food and Drug Administration-approved subcutaneous (SC) Immunoglobulin (Ig) treatment and can be safely self-administered by PI patients under a physician’s care in the United States. More.

05 March 2006
Study Shows Individual Replacement Therapy with C1-Inhibitor Concentrate Reduces Life-Threatening Hereditary Angioedema Attacks Compared With Current Treatment of Choice
Researchers concluded that individual replacement therapy (IRT) with C1-inhibitor (C1-INH) concentrate in patients with severe hereditary angioedema (HAE) significantly reduces the frequency of HAE attacks – especially life-threatening attacks – and significantly improves quality of life, compared to danazol. More.

05 March 2006
Study Finds Treatment with C1-Inhibitor Concentrate Relieves Abdominal Pain in Hereditary Angioedema Patients
C1-inhibitor (C1-INH) concentrate is effective in safely relieving abdominal pain and abdominal-wall tension in patients with hereditary angioedema (HAE) who experience abdominal attacks, according to data presented today at the American Academy of Allergy, Asthma & Immunology (AAAAI) 62nd Annual Meeting. According to the study, the first to report detailed and quantitative data on treated and untreated attacks of HAE in this large a sample size, in most attacks, relief of these symptoms occurred within 30 to 150 minutes after receiving C1-INH concentrate. More.

15 February 2006
ZLB Behring Announces Availability of Humate-P® with Smaller Diluent
ZLB Behring today announced that Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized) is now available featuring a smaller diluent - 50 percent less in all assay sizes. More.

07 February 2006
CSL to Apply for License to Market Influenza Vaccine in the U.S.
CSL Limited (ASX: CSL), a global, specialty biopharmaceutical company headquartered in Melbourne, Australia, today announced plans to introduce its influenza vaccine into the U.S. market. More.

09 January 2006
ZLB Behring Announces FDA Approval of Vivaglobin® -- The First Subcutaneous Immunoglobulin Replacement Therapy Approved in the U.S.
ZLB Behring today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Vivaglobin® (Immune Globulin Subcutaneous [Human]), an immunoglobulin (Ig) replacement therapy for treating patients with primary immunodeficiency (PI). Vivaglobin is the first and only FDA-approved subcutaneous (SC) Ig treatment, and can be safely self-administered by PI patients under a physician’s care in the United States. Vivaglobin is manufactured and marketed by ZLB Behring. More.

27 October 2005
Two-and-a-Half Million Women May Have A Bleeding Disorder…Without Even Knowing It
As many as 2.5 million women may have an undiagnosed bleeding disorder that, if not properly treated, could lead to serious health problems, medical experts told a mostly female audience at the National Hemophilia Foundation’s (NHF) 57th Annual Meeting today. Women with some forms of von Willebrand Disease (vWD) are at greater risk for miscarriage, life-threatening bleeding following surgery and childbirth, and for undergoing unnecessary hysterectomies. More.

12 October 2005
Infusion Nurses Examine Need for Standards of Practice in Immunoglobulin Therapy
A review article published in the July/August 2005 Journal of Infusion Nursing examines the need for established treatment guidelines to support doctors and nurses in correctly dosing and administering intravenous immunoglobulin (IVIG) as replacement therapy in patients with primary immunodeficiency (PI) disorders, who do not produce adequate levels of antibodies essential in fighting infectious diseases. More.

07 October 2005
FDA Approves Room Temperature Storage of ZLB Behring's Helixate® FS
ZLB Behring announced today that Helixate® FS has received approval to be stored at room temperature (up to 25°C, 77°F) for three months. The new storage guidelines for the treatment will provide users with greater flexibility and simplify storage options. More.

08 September 2005
ZLB Behring Lends Support to Patient Communities Affected by Hurricane Katrina
ZLB Behring Lends Support to Patient Communities Affected by Hurricane Katrina. ZLB Behring and its employees are making a number of donations in response to the devastation created by Hurricane Katrina. We are particularly concerned about the additional hardship this has placed on the patient communities we serve. As part of our ongoing commitment to the patient communities, we are providing additional support during this difficult time. More.

25 July 2005
ZLB Behring Introduces the Mix2Vial™ Alternate Transfer Device
Behring announced today the availability of the Mix2Vial Alternate Transfer Device, a new way to reconstitute products in 20/20 mm vials. More.