Bleeding Disorder News and Research

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CSL Behring initiates rVIIa-FP Phase I study in hemophilia A and B

CSL Behring announced today the first in human dosing of recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Phase I study will investigate in healthy volunteers the safety and pharmacokinetics of rVIIa-FP in comparison to placebo.

31 Mar 2012

Bayer receives FDA approval for lower dose formulation of ANGELIQ

Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a lower dose formulation of ANGELIQ (drospirenone and estradiol) tablets to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus.

29 Feb 2012

FDA grants orphan drug designation to CSL Behring's rVIIa-FP

CSL Behring announced today that the company has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its novel recombinant fusion protein linking coagulation factor VIIa with albumin.

16 Feb 2012

CSL Behring announces results of rIX-FP Phase I study on hemophilia B

CSL Behring today announced the results of a Phase I study evaluating recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP) in patients with severe hemophilia B.

3 Feb 2012

Gene therapy for bleeding disorder Hemophilia B

In a landmark study, researchers used gene therapy to successfully treat six patients with severe hemophilia, a blood-clotting disorder. Despite the early nature of the study, it is promising. A single infusion using the new treatment worked in some patients for more than a year, boosting their clotting ability significantly.

12 Dec 2011

Research examines novel treatment techniques for hemophilia B, VTE

Bleeding and clotting disorders affect a large number of patients annually and, while accurate diagnosis is important, timely and effective treatment for these disorders is key, as they have the potential to quickly become life-threatening. Research examining novel treatment techniques for bleeding and clotting disorders will be presented today at the 53rd Annual Meeting of the American Society of Hematology.

12 Dec 2011

Gene therapy can reduce painful bleeding episodes in patients with hemophilia B

Symptoms improved significantly in adults with the bleeding disorder hemophilia B following a single treatment with gene therapy developed by researchers at St. Jude Children's Research Hospital in Memphis and demonstrated to be safe in a clinical trial conducted at the University College London (UCL) in the U.K.

12 Dec 2011

Factors associated with increased risk of in-hospital falls after total hip or knee replacement surgery

Investigators from Hospital for Special Surgery have identified factors that are associated with an increased risk of in-hospital falls after total hip or knee replacement surgery.

5 Dec 2011

Inspiration commences enrollment in second OBI-1 Accur8 clinical trial program for congenital hemophilia A

Inspiration Biopharmaceuticals, Inc. today announced the initiation of patient enrollment in the second of two pivotal studies in the Company's OBI-1 Accur8 clinical trial program.

28 Nov 2011

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