Bleeding Disorder News and Research

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Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A

Bayer HealthCare today announced that the U.S. Food and Drug Administration has accepted the company's Biologics License Application 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.

4 Mar 2015

CSL Behring donates protein therapies to World Federation of Hemophilia

In recognition of Rare Disease Day and as part of its ongoing commitment to the global bleeding disorders community, CSL Behring announced today that it is donating 2 million international units (IUs) of protein therapies to the World Federation of Hemophilia.

28 Feb 2015

Spark Therapeutics, Pfizer partner to develop SPK-FIX for potential treatment of hemophilia B

Spark Therapeutics, a late-stage gene therapy company developing treatments for debilitating genetic diseases, announced today that it has entered into a global collaboration with Pfizer Inc. for the development and potential commercialization of SPK-FIX, a development program advancing proprietary, bio-engineered adeno-associated virus (AAV) vectors for the potential treatment of hemophilia B.

8 Dec 2014

Novo Nordisk reports positive data from Novoeight phase 3 study in people with haemophilia A

Today, Novo Nordisk announced a new analysis of phase 3 data demonstrating people with haemophilia A who had the highest annualised bleeding rate (ABR) during initial treatment with Novoeight (Antihemophilic Factor [Recombinant]) showed the largest reduction in bleeding over the duration of treatment.

From Novo Nordisk 7 Dec 2014

Apitope's ATX-F8-117 granted orphan medicinal product designation for treatment of haemophilia A

Apitope, the drug discovery and development company focused on disease-modifying treatments for patients with autoimmune and allergic diseases, announced today that the European Medicines Agency Committee for Orphan Medicinal Products has granted orphan medicinal product designation to ATX-F8-117 for the treatment of haemophilia A.

25 Nov 2014

Gene therapy transforms life for men with severe form of hemophilia B

Gene therapy developed at St. Jude Children's Research Hospital, University College London and the Royal Free Hospital has transformed life for men with a severe form of hemophilia B by providing a safe, reliable source of the blood clotting protein Factor IX that has allowed some to adopt a more active lifestyle, researchers reported.

19 Nov 2014

Cases of Ebola virus in West Africa continue to rise

Since the Ebola virus outbreak was first reported in March there have been nearly 2,000 cases and over 1,000 deaths in Guinea, Liberia, Nigeria, and Sierra Leone. This makes it the most serious Ebola epidemic to date.

15 Aug 2014

Bayer, Dimension Therapeutics partner to develop new gene therapy for hemophilia A

Dimension Therapeutics, a company focused on developing novel adeno-associated virus (AAV) gene therapy treatments for rare diseases, today announced it has entered into a collaboration with Bayer HealthCare (Bayer) for the development and commercialization of a novel gene therapy for the treatment of hemophilia A.

23 Jun 2014

FDA approves Bayer's Kogenate FS antihemophilic factor VIII to prevent bleeding episodes in adults with hemophilia A

Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Bayer's Kogenate® FS antihemophilic factor VIII (recombinant), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

12 May 2014

Baxter reports topline results from BAX 111 Phase 3 trial for treatment of von Willebrand disease

Baxter International Inc. today announced topline results from a Phase 3 clinical trial evaluating the safety, efficacy and pharmacokinetics (PK) of BAX 111. BAX 111 is a recombinant von Willebrand factor (rVWF) under investigation for the treatment of bleeding episodes in patients with von Willebrand disease, the most common type of inherited bleeding disorder.

From Baxter International Inc. 16 Apr 2014

Study outlines agenda to help direct future caffeine dependence research

"I'm a zombie without my morning coffee." "My blood type is Diet Coke." "Caffeine isn't a drug, it's a vitamin." Most people make jokes like these about needing a daily boost from their favorite caffeinated beverage-whether first thing in the morning or to prevent the after-lunch slump.

29 Jan 2014

CHOP scientist receives 2013 E. Donnall Thomas Prize for scientific, clinical research in hemophilia

Katherine A. High, M.D., of The Children's Hospital of Philadelphia (CHOP) was honored for her trailblazing scientific and clinical research in the bleeding disorder hemophilia when she received the 2013 E. Donnall Thomas Prize from the American Society of Hematology (ASH) at its annual meeting on Dec. 9 in New Orleans.

15 Dec 2013

CHOP scientist receives 2013 E. Donnall Thomas Prize for research in bleeding disorder hemophilia

Katherine A. High, M.D., of The Children's Hospital of Philadelphia was honored for her trailblazing scientific and clinical research in the bleeding disorder hemophilia when she received the 2013 E. Donnall Thomas Prize from the American Society of Hematology at its annual meeting on Dec. 9 in New Orleans.

14 Dec 2013

Late-breaking abstracts on treatment of blood cancers and bleeding disorders presented at ASH meeting

A range of studies highlighting late-breaking research advances in the understanding and treatment of blood cancers and bleeding disorders are being presented today during the 55th American Society of Hematology Annual Meeting and Exposition in New Orleans.

12 Dec 2013

Bleeding Disorder News and Research

Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A

CSL Behring donates protein therapies to World Federation of Hemophilia

Spark Therapeutics, Pfizer partner to develop SPK-FIX for potential treatment of hemophilia B

Novo Nordisk reports positive data from Novoeight phase 3 study in people with haemophilia A

Apitope's ATX-F8-117 granted orphan medicinal product designation for treatment of haemophilia A

Gene therapy transforms life for men with severe form of hemophilia B

Cases of Ebola virus in West Africa continue to rise

Bayer, Dimension Therapeutics partner to develop new gene therapy for hemophilia A

FDA approves Bayer's Kogenate FS antihemophilic factor VIII to prevent bleeding episodes in adults with hemophilia A

Baxter reports topline results from BAX 111 Phase 3 trial for treatment of von Willebrand disease

Study outlines agenda to help direct future caffeine dependence research

CHOP scientist receives 2013 E. Donnall Thomas Prize for scientific, clinical research in hemophilia

CHOP scientist receives 2013 E. Donnall Thomas Prize for research in bleeding disorder hemophilia

Late-breaking abstracts on treatment of blood cancers and bleeding disorders presented at ASH meeting

New smartphone app for patients with hemophilia and related bleeding disorders

UTHealth researchers find cause for rare type of bleeding disorder

FDA grants Orphan Drug Designation to Alnylam ALN-AT3 for treatment of hemophilia B

CHOP-led research increases numbers of patients who could be treated with gene therapy

Bayer starts enrollment in BAY94-9027 Phase II/III trial for hemophilia A in children

Study sheds light on stem cell technique for treatment of common bleeding disorder

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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