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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Bleeding Disorders
Hereditary Angioedema (HAE)
Fluid Management

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15 March 2009 C1-Esterase Inhibitor Concentrate Rapidly Relieves Acute Swelling Attacks Across All Body Sites in Patients with Hereditary Angioedema, According to Study

C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the 2009 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. Interim results from the ongoing, prospective, open label International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T. 2), showed a median time to the onset of symptom relief of 16 minutes for laryngeal attacks, 23 minutes for abdominal attacks, 28 minutes for facial attacks and 31 minutes for peripheral attacks, such as attacks in the hands and feet. In total, 57 patients who experienced 640 HAE attacks in any body location were studied.

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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.

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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.

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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.

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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.

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