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News Release Archive

This section features CSL Behring news releases that are more than 18 months old. Click the tabs to select releases in your area of interest. Click Resources to find additional background material on CSL Behring.

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12 October 2009 CSL Behring Announces FDA Approval of Berinert®, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Berinert® C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE), a rare and serious genetic disorder, in adult and adolescent patients. Berinert is the first and only therapy approved for this indication in the U.S. The approval is based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), which studied the efficacy and safety of C1-inhibitor (C1-INH) concentrate. The safety and efficacy of Berinert for prophylactic therapy have not been established.

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06 October 2009 CSL Behring Solicits Proposals for LEAD Grants to Support Patient Advocacy Efforts

CSL Behring, a global leader in the plasma-protein biotherapeutics industry, is calling for grant requests through its Local Empowerment for Advocacy Development (LEAD) program. The LEAD program awards funds to United States patient organizations that assist people with rare diseases in advocating for continued access to health care and life-saving plasma protein therapies.

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21 September 2009 Helixate FS from CSL Behring Now Available in 3000 IU Dosage Strength to Improve Patient Convenience

Hemophilia A patients who require high doses of Helixate® FS, Antihemophilic Factor (Recombinant), can now benefit from greater convenience in administering their treatment, thanks to a new 3000 IU (international unit) dosage strength. CSL Behring announced today that this new dosage strength is available in the U.S., allowing many patients to reduce reconstitution time by eliminating the need to mix and pool multiple vials of Helixate FS.

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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.

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28 July 2009 CSL Behring Awards Third Round of LEAD Grants Supporting Patient Organization Advocacy

CSL Behring, a global leader in the plasma-protein biotherapies industry, has awarded six advocacy grants totaling $100,000 to patient organizations in the United States through the Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support grassroots advocacy efforts by organizations that are committed to helping people who use plasma-derived and recombinant therapies to manage their health conditions. Since the LEAD program’s inception in 2008, CSL Behring has awarded more than $250,000 in three semi-annual grant cycles.

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