Talecris Press Release http://www.talecris.com Talecris Press Release RSS Feed en-us Tue, 09 June 2009 9:00:00 EST 60 lynne.witter@talecris.com (Lynne Witter) Copyright 2008, Talecris Biotherapeutics corporate.web@talecris.com (Talecris - Corporate Web) Tue, 09 June 2009 9:00:00 EST Reddot LiveServer http://www.talecris.com/images/talecriscorp.gif Talecris Press Release http://www.talecris.com 144 69 Talecris Biotherapeutics logo 0123456717181920212223 SaturdaySunday Talecris Receives Orphan Drug Designation for Plasmin http://www.talecris.com/Talecris-Receives-Orphan-Drug-Designation-for-Plasmin-press-release.htm Tue, 09 June 2009 9:00:00 EST Talecris Biotherapeutics, Inc. today announced that it has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the development of Plasmin (Human) to treat acute peripheral arterial occlusion (PAO). Talecris is currently investigating Plasmin in a phase I/II clinical trial designed to assess its ability to treat PAO, a condition in which arterial blood flow to the extremities, usually the legs, is blocked by a clot.  Currently, there are no FDA approved treatments for acute PAO. http://www.talecris.com/Talecris-Receives-Orphan-Drug-Designation-for-Plasmin-press-release.htm Alpha-1 Foundation Announces the Million Dollar Match http://www.talecris.com/Alpha-1-Million-Dollar-Match-Program-Made-Possible-by-Talecris-press-release.htm Thu, 04 June 2009 9:00:00 EST RESEARCH TRIANGLE PARK, N.C. and MIAMI, Fla.(June 4, 2009) — The Alpha-1 Foundation announced today it will receive up to $1 million in grant matching funds from Talecris Biotherapeutics, Inc. to support research into alpha1-antitrypsin deficiency, a genetic condition in which low levels of the essential blood protein alpha1-proteinase inhibitor, can cause emphysema. http://www.talecris.com/Alpha-1-Million-Dollar-Match-Program-Made-Possible-by-Talecris-press-release.htm Talecris Responds to U.S. Federal Trade Commission Filing http://www.talecris.com/Talecris-Responds-to-US-FTC-Filing-of-Complaint-to-Challenge-Proposed-CSL-Transaction.htm Thu, 28 May 2009 9:00:00 EST Talecris Biotherapeutics, Inc. yesterday was informed that the U.S. Federal Trade Commission (FTC) would file an administrative complaint challenging CSL’s proposed acquisition of Talecris and a complaint in U.S. Federal District Court to enjoin the transaction. http://www.talecris.com/Talecris-Responds-to-US-FTC-Filing-of-Complaint-to-Challenge-Proposed-CSL-Transaction.htm Talecris Presents New Data from Phase III Studies http://www.talecris.com/Talecris-Presents-New-Data-from-Phase-III-Prolastin-Studies-press-release.htm Mon, 18 May 2009 9:00:00 EST Talecris Biotherapeutics today presented results from two phase III studies assessing the safety, tolerability and pharmacokinetic comparability of a more concentrated formulation of Prolastin® (Alpha1-Proteinase Inhibitor [Human]) produced via a modification of the current manufacturing  process that incorporates technological changes. http://www.talecris.com/Talecris-Presents-New-Data-from-Phase-III-Prolastin-Studies-press-release.htm New Publication of Landmark Study Demonstrates http://www.talecris.com/Landmark-Study-Demonstrates-Gamunex-Improves-Health-Related-Quality-of-Life.htm Thu, 23 April 2009 9:00:00 EST RESEARCH TRIANGLE PARK, N.C. (April 23, 2009) — Talecris Biotherapeutics, Inc. today announced the publication of the health-related quality of life results from the largest clinical trial ever conducted in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) in the April 14, 2009 issue of Neurology.  The data demonstrate that long-term treatment with Gamunex (Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified) improves and maintains health-related quality of life in patients with CIDP. http://www.talecris.com/Landmark-Study-Demonstrates-Gamunex-Improves-Health-Related-Quality-of-Life.htm Talecris Names its 2009 Talents Grant Recipients http://www.talecris.com/Talecris-Names-its-2009-Talents-Grant-Recipients-press-release.htm Thu, 09 February 2009 13:00:00 EST Talecris Biotherapeutics, Inc. announced today the 2009 Talecris New Trials Support (Talents) grant recipients.  The Talents program, entering its fourth year, aims to advance basic and clinical research addressing the use of intravenous immunoglobulin (IGIV) in immunological, hematological, and neurological indications. The grants support either a one- or two-year research period and include funding for salary, overheads, and direct costs.  Talecris produces and markets Gamunex® (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified), a leading IGIV therapy. http://www.talecris.com/Talecris-Names-its-2009-Talents-Grant-Recipients-press-release.htm Thrombate III Approved for Room Temperature Storage http://www.talecris.com/Thrombate-III-Approved-for-Room-Temperature-Storage-press-release.htm Thu, 05 February 2009 16:00:00 EST Talecris Biotherapeutics announced today that Thrombate III [Antithrombin III (Human)], the plasma-derived antithrombin concentrate indicated for the treatment of hereditary antithrombin deficiency, can now be stored under room temperature conditions [not to exceed 25ºC (77ºF)]. Stability data at room temperature was approved by the Food and Drug Administration, and the updated Prescribing Information for Thrombate III now reflects the new labeling. http://www.talecris.com/Thrombate-III-Approved-for-Room-Temperature-Storage-press-release.htm Alpha-1 Foundation Awards Two Research Grants http://www.talecris.com/Alpha-1-Foundation-Awards-Research-Grants-with-Support-from-Talecris-press-release.htm Tue, 18 November 2008 09:00:00 EST The Alpha-1 Foundation announced today that it has awarded two new research grants for projects at the University of Florida and Brandeis University. The grants were made possible through an unrestricted charitable donation from Talecris Biotherapeutics to the Alpha-1 Foundation. http://www.talecris.com/Alpha-1-Foundation-Awards-Research-Grants-with-Support-from-Talecris-press-release.htm Talecris Helps Patients Receive Gamunex During Lapses in Private. http://www.talecris.com/Talecris-Helps-Patients-Receive-Gamunex-During-Lapses-in-Private-Insurance-Coverage.htm Tue, 15 October 2008 09:00:00 EST Under a new program introduced by Talecris Biotherapeutics, patients who regularly use Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) may be able to receive continuing treatment in the event of a lapse in private insurance coverage.
http://www.talecris.com/Talecris-Helps-Patients-Receive-Gamunex-During-Lapses-in-Private-Insurance-Coverage.htm
Health Canada Grants Approval to Talecris Biotherapeutics for Gamunex. http://www.talecris.com/Health-Canada-Grants-Approval-to-Talecris-for-Gamunex-as-Treatment-for-CIDP-in-Canada.htm Tue, 14 October 2008 09:00:00 EST Talecris Biotherapeutics, Ltd., a wholly-owned subsidiary of Talecris Biotherapeutics, Inc., announced today Health Canada has granted approval for Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating neurological disorder that results in muscle weakness and fatigue, which can lead to severe impairment of motor skills. http://www.talecris.com/Health-Canada-Grants-Approval-to-Talecris-for-Gamunex-as-Treatment-for-CIDP-in-Canada.htm Sub-Analysis of Phase III Study Suggests More than Single Treatment. http://www.talecris.com/Sub-Analysis-of-Phase-III-Study-Suggests-More-than-Single-Treatment-press-release.htm Tue, 23 September 2008 09:00:00 EST A study of a treatment for chronic inflammatory demyelinating neuropathy (CIDP) suggests that 50 percent of the patients who responded to treatment with Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) required two treatments before they first exhibited improvements on a standard disability measurement scale, according to data presented at the American Neurological Association meeting in Salt Lake City, Utah. The study authors concluded that “further studies in CIDP are warranted to more clearly define the duration of treatment required to achieve and maintain maximal response to IVIG therapy.” http://www.talecris.com/Sub-Analysis-of-Phase-III-Study-Suggests-More-than-Single-Treatment-press-release.htm Sub-Analysis of Phase III Suggests Long-Term Therapy May Improve. http://www.talecris.com/Sub-Analysis-of-Phase-III-Suggests-Long-Term-Therapy-May-Improve-press-release.htm Tue, 23 September 2008 09:00:00 EST Sub-analysis from a Phase III study of patients with a neurological disease, chronic inflammatory demyelinating polyneuropathy (CIDP), suggest that therapy with Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) may improve their physical and social functioning compared to placebo. Improvements in clinical symptoms also correlated with improvements in nerve function, according to the study funded by Talecris Biotherapeutics, Inc. The data were reported yesterday at the American Neurological Association meeting in Salt Lake City, Utah. http://www.talecris.com/Sub-Analysis-of-Phase-III-Suggests-Long-Term-Therapy-May-Improve-press-release.htm Jeffrey Modell Foundation and Talecris Expand Diagnostic Services http://www.talecris.com/JMF-and-talecris-expand-diagnostic-services-for-primary-immunodeficiencies-press-release.htm Thu, 18 September 2008 09:00:00 EST The Jeffrey Modell Foundation (JMF) and Talecris Biotherapeutics, Inc. have donated $150,000 to Children’s Hospital Boston, the primary pediatric teaching affiliate of Harvard Medical School to expand clinical care and outreach for children with primary immunodeficiency (PI), the two organizations announced today. http://www.talecris.com/JMF-and-talecris-expand-diagnostic-services-for-primary-immunodeficiencies-press-release.htm FDA Grants Approval to Talecris Biotherapeutics for Gamunex as a Treatment for Neurological Disorder CIDP in the United States http://www.talecris.com/FDA-Grants-Approval-to-Talecris-for-Gamunex-as-a-Treatment-for-CIDP-in-the-US-press-release.htm Mon, 15 September 2008 09:00:00 EST Talecris Biotherapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted approval for Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating neurological disorder that results in muscle weakness and fatigue, which can lead to severe impairment of motor skills. http://www.talecris.com/FDA-Grants-Approval-to-Talecris-for-Gamunex-as-a-Treatment-for-CIDP-in-the-US-press-release.htm Jeffrey Modell Foundation and Talecris Biotherapeutics Expand Diagnostic Services for Primary Immunodeficiencies at Children's Medical Center http://www.talecris.com/JMF-and-Talecris-Expand-Diagnostic-Services-for-Primary-Immune-Deficiencies-press-release.htm Fri, 12 September 2008 09:00:00 EST The Jeffrey Modell Foundation (JMF) and Talecris Biotherapeutics, Inc. have donated $150,000 to Children’s Medical Center to expand clinical care and outreach for children with primary immunodeficiency (PI), the two organizations announced today. http://www.talecris.com/JMF-and-Talecris-Expand-Diagnostic-Services-for-Primary-Immune-Deficiencies-press-release.htm Talecris Enters into Definitive Merger Agreement with CSL http://www.talecris.com/Talecris-Enters-into-Definitiave-Merger-Agreement-with-CSL-press-release.htm Tue, 12 July 2008 21:00:00 EST Talecris Biotherapeutics, Inc. (www.talecris.com) today announced that it has signed a definitive merger agreement with CSL under which CSL has agreed to acquire Talecris for $3.1 billion in cash. This amount includes net debt, which as of June 30, 2008 was approximately $1.2 billion, implying an equity value as of that date of about $1.9 billion. http://www.talecris.com/Talecris-Enters-into-Definitiave-Merger-Agreement-with-CSL-press-release.htm Talecris Biotherapeutics Receives Orphan Drug Designation for Aerosolized Form of Alpha-1 Antitrypsin (AAT) From the European Commission http://www.talecris.com/Talecris-Receives-Orphan-Drug-Designation-for-Aerosolized-Form-of-Alpha1-Antitrypsin-press-release.htm Thu, 24 July 2008 09:00:00 EST Talecris Biotherapeutics, Inc. (www.talecris.com) announced today that the European Commission followed an opinion of the Committee for Orphan Medicinal Products (COMP) and has granted orphan drug designation to Talecris’ alpha1 proteinase inhibitor [human] for inhalation use in the treatment of congenital Alpha1-Antitrypsin Deficiency (also known as AAT Deficiency or Alpha-1). Currently, there are no approved aerosolized treatments available for augmentation therapy for AAT Deficiency. http://www.talecris.com/Talecris-Receives-Orphan-Drug-Designation-for-Aerosolized-Form-of-Alpha1-Antitrypsin-press-release.htm Talecris Biotherapeutics, Inc. Provides Business Update http://www.talecris.com/Talecris-Biotherapeutics-Inc-Provides-Business-Update-presss-release.htm Mon, 16 June 2008 09:00:00 EST Talecris Biotherapeutics, Inc. (www.talecris.com) disclosed today that it is on-track with the vertical integration of its plasma supply chain and that it has successfully completed a complex upgrade of its manufacturing facility located in Clayton, North Carolina, all intended to ensure increased supply of its plasma-based life-enhancing therapies to customers. http://www.talecris.com/Talecris-Biotherapeutics-Inc-Provides-Business-Update-presss-release.htm Talecris Biotherapeutics Awarded MedAssets Supply Chain Systems' Platinum Vendor Designation http://www.talecris.com/Talecris-Awarded-MedAssets-Supply-Chain-Systems-Platinum-Vendor-press-release.htm Thu, 22 May 2008 09:00:00 EST Talecris Biotherapeutics, Inc. announced today that the company recently earned MedAssets Supply Chain Systems’ Platinum Vendor status award. The platinum level is the highest vendor designation awarded by MedAssets Supply Chain Systems, a MedAssets company. MedAssets is one of the largest U.S. group purchasing and supply chain organizations. http://www.talecris.com/Talecris-Awarded-MedAssets-Supply-Chain-Systems-Platinum-Vendor-press-release.htm Talecris Announces 2008 Application Cycle for Talents Research Grants, Presents 2007 Grant Awardees http://www.talecris.com/Talents-Research-Grants-2008-Application-Cycle-2007-Grant-Awardees-press-release.htm Wed, 14 May 2008 09:00:00 EST Program grants $1 million to clinicians and scientists implementing novel studies with intravenous immunoglobulin therapies. The Talecris New Trials Support program (Talents), sponsored by Talecris Biotherapeutics, Inc., is now accepting applications for the 2008 research grants cycle. The Talents program, entering its third year, aims to advance basic and clinical research addressing the use of intravenous immunoglobulin (IGIV) in immunological, hematological, and neurological indications. Totaling $1 million, the grants support either a one- or two-year research period and include funding for salary, overheads, and direct costs. http://www.talecris.com/Talents-Research-Grants-2008-Application-Cycle-2007-Grant-Awardees-press-release.htm FDA Grants Priority Review of Gamunex as a Treatment for Neurological Disorder CIDP http://www.talecris.com/FDA-Grants-Priority-Review-of-Gamunex-as-a-Treatment-for-Neurological-Disorder-CIDP-press-release.htm Thu, 08 May 2008 09:00:00 EST Talecris Biotherapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted a Priority Review of Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). http://www.talecris.com/FDA-Grants-Priority-Review-of-Gamunex-as-a-Treatment-for-Neurological-Disorder-CIDP-press-release.htm Talecris Partners with Catalent Pharma Solutions for European Contract Manufacturing and Product Testing http://www.talecris.com/Talecris-Partners-with-Catalent-Pharma-Solutions-press-release.htm Mon, 28 Apr 2008 09:00:00 EST Talecris Biotherapeutics, Inc. announced today that the company has entered into an exclusive agreement with Catalent Pharma Solutions to perform final release testing, packaging and labeling for all its products distributed in Europe for the next five years. This partnership designates Catalent as the primary contract manufacturer in Europe for Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified), Prolastin (Alpha1-Proteinase Inhibitor [Human]) and a range of other commercial plasma products. http://www.talecris.com/Talecris-Partners-with-Catalent-Pharma-Solutions-press-release.htm Talecris Biotherapeutics Awarded Manufacturing Contract to Supply Canada with Biological Therapies for the 20th Consecutive Year http://www.talecris.com/Talecris-Awarded-Manufacturing-Contract-to-Supply-Canada-with-Biological-Therapies-press-release.htm Mon, 31 Mar 2008 09:00:00 EST Talecris Biotherapeutics, Inc. announced today that the company has been selected by Canadian Blood Services and Hema-Quebec as the primary fractionator for Canadian plasma and the primary supplier of immune globulin intravenous (IGIV) during the next five years. This contract, beginning April 1, 2008, designates Talecris as the primary supplier of immune globulin intravenous (IGIV) through its product Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified), and a range of other commercial plasma products. http://www.talecris.com/Talecris-Awarded-Manufacturing-Contract-to-Supply-Canada-with-Biological-Therapies-press-release.htm