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Immune Globulin Intravenous News

FDA Approves Biotest's Bivigam, an Intravenous Immune Globulin (Human), 10% Liquid

Posted 29 Dec 2012 by Drugs.com

DREIEICH, Germany and BOCA RATON, Fla., Dec. 20, 2012 /PRNewswire/ – Biotest AG announced today that Biotest Pharmaceuticals Corporation received approval for Bivigam for the treatment of patients with Primary Humoral Immunodeficiency (PI) from the U.S. Food and Drug Administration (FDA). Bivigam is the first polyspecific intravenous immune globulin manufactured in the U.S. by Biotest Pharmaceuticals Corporation (BPC) at its Boca Raton, Florida facility. This product is being produced for patients in the United States, and the company plans to begin commercial shipments shortly. Prof. Dr. Gregor Schulz , CEO of Biotest AG, said: "Biotest has made a significant commitment in the U.S. to bring a new immune globulin to individuals with primary immunodeficiency. We have invested over $50 million to create a state-of-the-art facility and have expanded our U.S. capabilities from plasma ... Read more

Related support groups: Primary Immunodeficiency Syndrome, Immune Globulin Intravenous

Densensitization Procedure Helps Hard-to-Match Kidney Recipients

Posted 27 Jul 2011 by Drugs.com

WEDNESDAY, July 27 – A combination therapy that "desensitizes" kidney transplant recipients could help hard-to-match patients find a needed kidney faster. The desensitization procedure combines the use of plasmapheresis – a machine that filters the blood plasma to remove antibodies – and low-doses of a medication called intravenous immune globulin (IVIG). The combination of these therapies improves survival rates dramatically. Eight years after receiving a transplant, survival rates were 81 percent for those who received the treatment compared to just 31 percent for people who had to stay on dialysis, new research found. "This is a huge unmet problem. There are probably as many as 30,000 people who have been exposed to foreign tissue waiting for a kidney. They're really hard to match," explained study author Dr. Robert Montgomery, director of the comprehensive transplant program at ... Read more

Related support groups: Renal Transplant, Gammagard, Gamunex, Privigen, Immune Globulin Intravenous, Sandoglobulin, Carimune, Panglobulin NF, Gammar-P IV, Carimune NF, Venoglobulin-S 10%, Iveegam En, Gamimune, Panglobulin, Gamimune N 5%, Gammaplex, Polygam S/D, Gammagard S/D, Flebogamma, Venoglobulin-S 5%

CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen from 24 to 36 Months

Posted 20 Apr 2010 by Drugs.com

KING OF PRUSSIA, Pa., April 19 /PRNewswire/ – 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 for Privigen, Immune Globulin Intravenous (Human), 10% Liquid, from 24 to 36 months. The approval makes Privigen the first liquid intravenous immunoglobulin (IVIg) in the U.S. that can be stored at room temperature throughout its entire 36-month shelf life. Privigen is the first and only 10 percent liquid IVIg stabilized with proline, a naturally occurring amino-acid. The product is indicated for primary immunodeficiency (PI), a group of disorders, usually genetic, that result from a malfunction in part or all of the immune system. This condition prevents patients from fighting off infections caused by everyday germs. Privigen is also indicated for the treatment of patients ... Read more

Related support groups: Privigen, Immune Globulin Intravenous

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Related Condition Support Groups

Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Chronic Lymphocytic Leukemia (CLL), Idiopathic (Immune) Thrombocytopenic Purpura, Autoimmune Neutropenia, Bone Marrow Transplantation, Primary Immunodeficiency Syndrome, Evan's Syndrome, Kawasaki Disease, HIV Infection, Polymyositis / Dermatomyositis, Anti NMDA Receptor Encephalitis, Myasthenia Gravis

Related Drug Support Groups

Gamunex, Privigen, Sandoglobulin, Carimune, Panglobulin, Panglobulin NF, Gammar IV, Gamimune, Gamimune N 10%, view more... Gamimune N 5%, Gammagard S / D, Gammar-P IV, Flebogamma, Octagam, Bivigam, Venoglobulin-S 10%, Venoglobulin-S 5%, Carimune NF, Gammaplex, Polygam S / D, Iveegam En

Immune Globulin Intravenous Patient Information at Drugs.com