Hemophilia B News and Research

RSS

Physical activity associated with increased risk of bleeding in children with hemophilia

Hemophilia is a bleeding disorder that, if untreated, causes recurrent bleeding into joints. "Vigorous physical activity is thought to increase risk of bleeds in children with hemophilia, but the magnitude of the risk is unknown," according to background information in the article. Information about risks associated with physical activity is needed to help inform decisions regarding participation in physical activity, the authors write.

10 Oct 2012

Positive results from Sobi, Biogen Idec's rFIXFc Phase 3 trial on hemophilia B

Biogen Idec and Swedish Orphan Biovitrum (Sobi) today announced positive results from B-LONG, a clinical study that evaluated a new long-lasting clotting factor candidate in people with hemophilia B. Hemophilia B is a rare inherited disorder that impairs blood coagulation.

27 Sep 2012

Roundup: Ore. insurance CO-OP readies coverage; N.J. Medicaid liabilities hurt state's fiscal outlook; Wis. AG appeals collective bargaining ruling

Independent workers -- artists, journalists, information technology professionals, craftsmen and even those who earn their living buying and selling on eBay -- will soon have the ability to buy health coverage without having to dicker with a privately-run insurance company such as Regence BlueCross BlueShield. ... people can sign up when enrollment opens for the health insurance exchange in October 2013.

20 Sep 2012

Alnylam announces complete results from ALN-RSV01 Phase IIb trial on RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today complete results from its Phase IIb trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection in lung transplant patients.

6 Sep 2012

Baxter seeks FDA BLA approval for BAX 326 rFIX protein to treat hemophilia B

Baxter International Inc. today announced that the company has submitted a biologics license application to the United States Food and Drug Administration for approval of BAX 326, a recombinant factor IX (rFIX) protein being investigated for the treatment and prophylaxis of bleeding episodes for patients over 12 years of age with hemophilia B.

From Baxter International Inc. 5 Sep 2012

Ipsen, Inspiration partner to commercialize IB1001 and OBI-1 for hemophilia

Inspiration Biopharmaceuticals Inc. today announced new license, development and commercialization agreements with its strategic partner, Ipsen.

21 Aug 2012

uniQure receives positive recommendation from EMA CHMP for Glybera

uniQure announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion that recommends marketing authorization of Glybera (alipogene tiparvovec) as a treatment for lipoprotein lipase deficiency (LPLD) under exceptional circumstances.

21 Jul 2012

Sanquin, Baxter enter manufacturing services agreement for plasma therapies

Baxter International Inc. today announced that it has entered into a manufacturing services agreement with Stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation) in the Netherlands that will provide Baxter up to 1.6 million liters of incremental plasma fractionation capacity annually to support global growth of plasma-derived treatments.

From Baxter International Inc. 20 Jul 2012

Emmaus receives EC Orphan Medicinal Product designation for Levoglutamide

Emmaus Medical, Inc., a specialty pharmaceutical and regenerative medicine technology company, and subsidiary of Emmaus Life Sciences, Inc., today announced that the European Commission (EC) has granted Orphan Medicinal Product designation for the company's investigational drug Levoglutamide (L-glutamine) for the treatment of sickle cell disease.

18 Jul 2012

PROLOR to present data on long-acting clotting factors for hemophilia at WFH World Congress

PROLOR Biotech, Inc., announced that the company will present data today on its long-acting clotting factors for the treatment of hemophilia at the World Federation of Hemophilia (WFH) World Congress.

11 Jul 2012

Roundup: Tough to get on Calif.'s new adult day care

Community-Based Adult Services began March 1 as part of a legal settlement between the state and advocates that sued over Gov. Jerry Brown's plan to eliminate Adult Day Health Care entirely.

11 Jul 2012

Inspiration receives FDA clinical hold order for IB1001 phase III studies on hemophilia B

Ipsen announced today that its partner Inspiration Biopharmaceuticals Inc. (Inspiration) was notified by the Food and Drug Administration (FDA) that both clinical trials evaluating the safety and efficacy of IB1001, an investigational intravenous recombinant factor IX (rFIX) therapy for the treatment and prevention of bleeding episodes in people with hemophilia B, were placed on clinical hold.

10 Jul 2012

Positive interim results from Inspiration's OBI-1 Phase 2/3 study for acquired hemophilia A

Inspiration Biopharmaceuticals, Inc. today reported data from its ongoing Phase 2/3 study evaluating the efficacy of OBI-1, an investigational recombinant porcine factor VIII (FVIII), for the treatment of serious bleeds in people with acquired hemophilia A. According to the interim analysis, seven out of seven trial participants receiving OBI-1 experienced control and subsequent resolution of their bleeds.

9 Jul 2012

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

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.

8 Jul 2012

China SFDA approves China Biologic's Human Coagulation Factor VIII

China Biologic Products, Inc., a leading fully integrated plasma-based biopharmaceutical company in China, today announced that its indirectly owned subsidiary, Shandong Taibang Biological Products Co., Ltd. has received a manufacturing approval certificate from the China State Food and Drug Administration for Human Coagulation Factor VIII ("FVIII").

25 Jun 2012

New U-M hESC lines now available for federally-funded research

Six new human embryonic stem cell lines derived at the University of Michigan have just been placed on the U.S. National Institutes of Health's registry, making the cells available for federally-funded research.

15 Jun 2012

CSL Behring rIX-FP granted Orphan Drug Designation to treat hemophilia B

CSL Behring announced today that the company has been granted Orphan Drug Designation by the United States Food and Drug Administration for its novel recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP).

8 Jun 2012

Chatham, Baxter partner to develop and commercialize hemophilia B gene therapy treatment

Baxter International Inc. today announced that it has entered into an exclusive global agreement with Chatham Therapeutics, LLC, an affiliate of Asklepios BioPharmaceutical, Inc. (AskBio), for the development and commercialization of potential treatments for hemophilia B utilizing Chatham's gene therapy technology.

From Baxter International Inc. 5 Jun 2012

Top-line results from Alnylam’s ALN-RSV01 Phase IIb trial on RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today top-line results from a Phase IIb trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection in lung transplant patients.

31 May 2012

Chinese sFDA approves Baxter's ADVATE to treat hemophilia A

Baxter International Inc. today announced the approval of ADVATE [Recombinant Human Coagulation Factor VIII for injection] for the control and prophylaxis of bleeding episodes in individuals with hemophilia A (congenital factor VIII deficiency) in China by the State Food and Drug Administration.

From Baxter International Inc. 17 May 2012