Receive Our Newsletter

Hemophilia Bleeding Disorder Industry News

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 […]

Life Sciences Firm Entegrion Lands Global Partner

Research Triangle Park, N.C. — Blood technologies company Entegrion is partnering with an Italian company to develop and commercialize Resusix, Entegrion’s freeze-dried human plasma. Under the deal, Kedrion Melville gains exclusive worldwide rights to commercialize Resusix. Entegrion, based in Research Triangle Park, will collaborate with Kedrion on clinical development of the product. Clinical trials are […]

FDA Accepts Biogen Idec’s License Application for First Long-Lasting Factor Therapy for Hemophilia B

WESTON, Mass.-Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has accepted the company`s Biologics License Application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B and granted the company a standard review timeline. Recombinant FIXFc is the first product candidate in […]

BioRx

BioRx Introduces National Physical Therapy Program

CINCINNATI, Ohio  - BioRx announced today the launch of a new physical therapy program to help patients, physicians, physical therapists, and health insurers manage the complications and costs of hemophilia-related joint damage. The program, called REBUILD, supports a patient’s physical therapy program at the local level. Under the direction of an experienced physical therapist for […]

NY Times: Dispute Develops Over Discount Drug Program

By: Andrew Pollack  When a private oncology practice in Memphis formed a partnership with a nearby hospital in late 2011, the organizations proclaimed that the deal would “transform cancer care” in the region. What they did not emphasize was that the deal would also create a windfall for them worth millions of dollars a year, […]

ATHN and The Hemophilia Alliance Announce Memorandum of Understanding

February 6, 2013  – The Hemophilia Alliance and the American Thrombosis and Hemostasis Network (ATHN) are pleased to announce they have entered into a Memorandum of Understanding to provide financial assistance to ATHN in support of the ATHN Data Quality Counts program for Hemophilia Treatment Centers (HTCs) across the country. Funding from the Hemophilia Alliance […]

Page 5 of 1312345678910NextLast »

Assisting and Advocating for the Bleeding Disorders Community