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Hemophilia Bleeding Disorder Industry News

Covidien Initiates a Voluntary Recall of Certain Lots of Monoject™ Prefill Flush Syringes

Mansfield, MA – Covidien today announced that it has initiated a voluntary recall of certain lots of Monoject™ prefill flush syringes. Reasons for Recall: This recall is being conducted due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process. These products are labeled […]

Genetic Alliance has Launched a New Resource

The Genetic Alliance has launched a new resource at GenesInLife.org to help patients learn about genetics and health. In a time when searching for quality health information can be like searching for a needle in a haystack, Genetic Alliance is thrilled to announce the launch its newest public resource, Genesinlife.org. Genes in Life harmonizes many existing resources […]

First Ever Patient Needs Survey Launched for National Hemophilia Program

The National Hemophilia Program Coordinating Center (NHPCC), funded by the federal government through the American Thrombosis and Hemostasis Network, a nonprofit organization committed to advancing and improving care for individuals with bleeding and clotting disorders, announced rollout today of the first ever national hemophilia program patient needs survey. The NHPCC is working with over 130 […]

CSL Behring Joins American Thrombosis and Hemostasis Network

Riverwoods, IL – The American Thrombosis and Hemostasis Network (ATHN), a nonprofit organization committed to advancing and improving care for individuals with bleeding and clotting disorders, announced today that CSL Behring is providing funding to ATHN as a Supporting Member of the ATHN Industry Consortium. This funding will help ATHN continue to strengthen and enhance […]

Bayer Announces 2013 Recipients of Hemophilia Awards Program

Wayne, NJ  – Bayer HealthCare has announced the 2013 recipients of the Bayer Hemophilia Awards Program (BHAP). This year, the company awarded more than $2 million in funding to 16 recipients in nine countries, including six in the U.S. BHAP is the largest program of its kind in hemophilia, funding innovative research and educational initiatives […]

Bayer Initiates Phase III Trial of an Investigational Recombinant Factor VIII

WAYNE, NJ, (July 8, 2013) – Bayer HealthCare today announced the company has started to enroll patients in an international Phase II/III trial to evaluate its investigational compound BAY94-9027 for the treatment of hemophilia A in children. The PROTECT VIII (PROphylaxis in hemophilia A patienTs via directly pEgylated long-aCTing rFVIII) Kids trial is designed to […]

FDA Approves Baxter’s Prophylaxis Treatment of Hemophilia B

FDA Approves Baxter’s RIXUBIS as First Recombinant Factor IX Treatment for Routine Prophylaxis of Hemophilia B Approval brings patients first new rFIX treatment option in more than 15 years DEERFIELD, Ill.–(BUSINESS WIRE)– Baxter International Inc. (NYS: BAX) today announced that the United States Food and Drug Administration (FDA) has approved RIXUBIS [Coagulation Factor IX (Recombinant)] […]

Baxter’s Response to FDA Warning Letter

Baxter Healthcare Corporation received a Warning Letter from FDA dated May 31, 2013 regarding operations and processes at its Marion (North Cove), North Carolina and Jayuya, Puerto Rico facilities. The Baxter facilities that received the FDA Warning Letter are not involved in the production of any treatments processed by Baxter’s BioScience Division including hemophilia clotting […]

CSL Behring Doses First Hemophilia A Patient in Part 3 of Global Phase

King of Prussia, — CSL Behring has dosed the first patient in Part 3 of its AFFINITY clinical trial program, which is now in phase III. AFFINITY is an open-label, non-randomized, multi-center study evaluating the efficacy, safety and pharmacokinetics of its novel investigational recombinant coagulation single-chain factor VIII (rVIII-SingleChain) for the treatment of hemophilia A. […]

Baxter Reinforces Commitment To Disparities In Care And Shares A New Vision

Baxter Healthcare Corporation announced its continued commitment to the hemophilia community to close the gap in hemophilia care and the company’s vision to pursue a bleed-free world for people living with this disorder on World Hemophilia Day. For more than 60 years, Baxter has been a dedicated partner to the hemophilia community and is committed […]

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