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Hemophilia Bleeding Disorder Industry News
Industry News

FDA Accepts CSL Behring’s Application for New Hemophilia Treatment

Note: The below is an edited press release from CSL Behring. To read the full release, click here. CSL Behring announced that the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A. In the […]

Industry News

Baxalta Releases Findings of Potential Extended Half-Life Product

Note: This is an edited form of a press release from Baxalta, Inc., originally published on July 16, 2015. To read the full press release, click here. Baxalta Incorporated announced the publication of the complete data from the Phase II/III pivotal study and Phase I trial of BAX 855 in Blood, the journal of the […]

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FDA Grants Orphan Status for New Inhibitor Treatment

Below is from a press release Apitope sent out on June 9, 2015. To read it in its entirety, click here. Apitope, the drug discovery and development company focused on disease-modifying treatments that reinstate immune tolerance, announced today that pre-clinical product candidate ATX-F8-117 has been granted Orphan Drug Status by the US Food and Drug […]

Industry News

FDA Approves New Hemophilia B Treatment

  Note: This is an edited version of a Emergent BioSolutions Inc. press release. To read the full release, click here. Emergent BioSolutions Inc. announced on Thursday, April 29 the U.S. Food and Drug Administration (FDA) has approved IXINITY®, an intravenous recombinant human coagulation factor IX therapeutic for the control and prevention of bleeding episodes and for perioperative management […]

Industry News

CSL Behring Renews Pledge to World Federation of Hemophilia

  In recognition of World Hemophilia Day April 17, the World Federation of Hemophilia (WFH) and CSL Behring announced today that CSL Behring has once again committed to donating bleeding disorder protein therapy international units (IUs) to the WFH Global Alliance for Progress (GAP) Program and other WFH programs, as well as making significant financial […]

Industry News

Kedrion Announces Safer Manufacture Process for Koate Antihemophilic Factor

Note: This is an edited version of a Kedrion press release. To read the full release, click here.  ____________________ Kedrion Biopharma proudly announced that Koate® Double Viral Inactivation (DVI) Antihemophilic Factor (human) is now being manufactured using a process that further enhances the safety and purity of that product. Koate-DVI is used in the treatment […]

Medical News

Reuters: Britain’s Prime Minster Apologizes For Infected Blood In 70s, 80s

British Prime Minister David Cameron apologized on Wednesday, March 26, 2015 to thousands of people who were infected with HIV and Hepatitis C after being treated for unrelated conditions with contaminated blood in the 1970s and 1980s. Survivors and relatives of people who died after being infected through blood therapies or transfusions have campaigned for […]

Industry News

Baxter Sees Promising Results in Inhibitor Treatment Trial

Baxter International Inc. announced positive results from its Phase III clinical trial evaluating the safety and efficacy of BAX 817, an investigational recombinant factor VIIa (rFVIIa) treatment for people with Hemophilia A or B who develop inhibitors. The prospective, open-label, randomized, multicenter trial was designed to assess the safety and efficacy of BAX 817 in […]

Industry News

FDA Accepts Bayer’s Application for New Hemophilia Treatment

Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for BAY 81-8973, a recombinant Factor VIII compound. Bayer is seeking FDA approval of the investigational compound, proposed trade name Kovaltry™, for the treatment of hemophilia A in children and adults. “Bayer is committed to continually […]

Industry News

Biogen Idec and Sobi See Progress in Pediatric Hemophilia B Study

This is an edited version of a press release from Biogen Idec. To read the full release, please click here. ____________________ Biogen Idec  and Swedish Orphan Biovitrum AB announced positive top-line results of the Kids B-LONG Phase 3 clinical study that evaluated the safety, efficacy and pharmacokinetics of ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] in children under […]

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