News Room
19 August 2008
Voluntary Withdrawal of Monoclate-P® Initiated
CSL Behring L.L.C. has voluntarily decided to initiate a recall of Monoclate-P®, 1000 Unit, lots J91504, J91604, J91705 and J91806, with expiration dates of April 25, April 30, May 2, and June 9, 2010, respectively. This action is being taken with the knowledge of the Food and Drug Administration.
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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.
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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.
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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.
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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.
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01 August 2007
CSL Behring 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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 Rh
0(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 Rh
0(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.
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14 August 2006
Distribution Annoucement
This is to inform you that ZLB Behring has decided to in-source our warehouse and distribution functions. Since 2004, ZLB Behring outsourced these services to a third party logistics management company, RX Crossroads, (formerly known as MDI), to store and distribute products on our behalf. We will continue to utilize RX Crossroads’ services throughout 2006 as we deplete inventory at their warehouse.
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