Bleeding Disorder News and Research

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Inspiration initiates second OBI-1 phase III clinical trial in congenital hemophilia A with inhibitors

Ipsen today announced that its partner Inspiration Biopharmaceuticals, Inc. has initiated the treatment of the first patient in the second of two pivotal studies from the OBI-1's Accur8 clinical trial program.

28 Nov 2011

Gene therapy and stem cell transplantation successfully reverse hemophilia A

For the first time, researchers have combined gene therapy and stem cell transplantation to successfully reverse the severe, crippling bleeding disorder hemophilia A in large animals, opening the door to the development of new therapies for human patients.

3 Nov 2011

Thromboelastograph analyzer can help save lives of trauma patients

Researchers from the University of Notre Dame's Keck Center and trauma physicians at South Bend's Memorial Hospital are joining forces to use a new medical technology to help save the lives of trauma patients.

3 Nov 2011

Massive clotting can destroy placenta and cause miscarriages

Researchers at St. Michael's Hospital have identified a potential new cause for unexplained miscarriages in mice.

2 Nov 2011

Baxter commences BAX 111 Phase III trial in von Willebrand disease

Baxter International Inc. today announced initiation of a Phase III clinical trial to evaluate the safety and effectiveness of BAX 111, Baxter's investigational recombinant von Willebrand factor (rVWF), for the treatment and prevention of bleeding episodes in patients with von Willebrand disease.

From Baxter International Inc. 14 Oct 2011

New AAOS guideline recommends how to reduce DVT, PE after joint replacement surgery

An updated clinical practice guideline released last week by the American Academy of Orthopaedic Surgeons (AAOS) Board of Directors recommends how to reduce the likelihood of blood clots after hip or knee replacement surgery, procedures that more than 800,000 Americans undergo each year. The new guideline suggests use of preventive treatments and advises against routinely screening patients after surgery using ultrasound imaging.

1 Oct 2011

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban, a novel, once-daily, oral anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

9 Sep 2011

Ipsen, Inspiration partner to launch hemophilia product portfolio in Europe

Ipsen and Inspiration Biopharmaceuticals Inc. today announced they have entered into a strategic partnership agreement, to create a European hemophilia commercial organization, to launch Inspiration's hemophilia product portfolio in Europe.

30 Aug 2011

New book on hemophilia, unintended consequences of medical progress

The Bleeding Disease: Hemophilia and the Unintended Consequences of Medical Progress (John Hopkins University Press) is the new book by NJIT Associate Professor Stephen Pemberton. The book recounts the promising and perilous history of medical and social efforts to manage hemophilia in 20th-century America.

19 Aug 2011

Inspiration presents OBI-1 pivotal study data on hemophilia at 23rd ISTH congress

Ipsen today announced that its partner Inspiration Biopharmaceuticals, Inc. presented data from its clinical development program for OBI-1, an intravenous (IV) recombinant porcine factor VIII product (rpFVIII), intended for the treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia.

28 Jul 2011

New preclinical data from Baxter's BAX 499 hemophilia study presented at ISTH

Baxter International Inc. announced today that new data from a series of studies on BAX 499, an investigational compound for potential subcutaneous hemophilia therapy, were presented this week during the 23rd annual congress of the International Society on Thrombosis and Haemostasis (ISTH) in Kyoto, Japan.

From Baxter International Inc. 27 Jul 2011

Researchers identify elusive gene responsible for Grey Platelet Syndrome

Researchers have identified an elusive gene responsible for Grey Platelet Syndrome, an extremely rare blood disorder in which only about 50 known cases have been reported. As a result, it is hoped that future cases will be easier to diagnose with a DNA test.

26 Jul 2011

Key finding sheds new light on common bleeding disorders

A simple cut to the skin unleashes a complex cascade of chemistry to stem the flow of blood. Now, scientists at Washington University School of Medicine in St. Louis have used evolutionary clues to reveal how a key clotting protein assembles. The finding sheds new light on common bleeding disorders.

21 Jul 2011

European Commission grants Orphan Drug Designation for CSL Behring's rVIIa-FP to treat hemophilia

CSL Behring announced today that it has been granted Orphan Drug Designations by the European Commission for the development of its recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP), a novel therapy to treat hemophilia A and hemophilia B patients with inhibitors.

1 Jun 2011

Bayer expands sponsorship agreement with World Federation of Hemophilia

Bayer HealthCare Pharmaceuticals and the World Federation of Hemophilia are announcing a three-year extension of Bayer's sponsorship agreement with WFH.

29 Apr 2011

FDA approves Bayer's new Kogenate FS storage option for hemophilia A treatment

Bayer HealthCare Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved a new storage option for Kogenate FS, antihemophilic factor, now allowing the product to be stored at room temperature for up to one year.

26 Apr 2011

Ipsen 2010 total revenues increase 5.2% to €1,170.3 million

In 2010, Group drug sales grew 5.1% year-on-year - at constant currency - exceeding the objective set a year ago of 3.0% to 5.0%, fuelled notably by the sales of Specialty Care products throughout all the geographical regions where the Group operates.

2 Mar 2011

Novo Nordisk submits rFXIII BLA to FDA for treatment of inherited bleeding disorder

Novo Nordisk announced today that a Biologic License Application has been submitted to the U.S. Food and Drug Administration requesting the approval of a recombinant factor XIII compound for the vast majority of patients with congenital factor XIII deficiency, an inherited bleeding disorder.

From Novo Nordisk 23 Feb 2011

FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact™, Factor XIII Concentrate (Human), for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency. Corifact, already available for use in 12 countries throughout the world under the trade name Fibrogammin®- P, is the first and only FXIII concentrate approved in the U.S.

19 Feb 2011

Rare bleeding disorder misdiagnosed

A rare bleeding disorder that can lead to life-threatening bleeding episodes is misdiagnosed in 15 per cent of cases according to findings from a new international research project led by a Queen's professor.

17 Feb 2011