Von Willebrand Disease News and Research

Latest Von Willebrand Disease News and Research

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

Baxter seeks FDA approval of BAX 855 for treatment of people with hemophilia A

Nektar Therapeutics reported that partner Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the United States Food and Drug Administration for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].

From Baxter International Inc. 1 Dec 2014

CSL Behring strengthens global manufacturing capabilities to meet demand for lifesaving therapies

CSL Behring today announced a multi-year, $450 million two-site global capacity expansion – the latest in a series of recent production expansions to meet the growing need for its lifesaving and life-improving therapies that are used to treat patients with rare and serious medical disorders around the world.

8 Oct 2014

School nurses reach 98% of students in U.S. public schools to diagnose primary immunodeficiency

School nurses reach 98 percent of the 50,000,000 students in U.S. public schools, grades k-12, and are uniquely positioned to facilitate the early diagnosis of serious medical conditions such as primary immunodeficiency (PI).

28 Aug 2014

Baxter reports positive results from BAX 855 Phase 3 trial for hemophilia A

Nektar Therapeutics reports Baxter International Inc. today announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], which met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to the on-demand arm.

From Baxter International Inc. 22 Aug 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

CSL Behring enrolls first patient in phase III study of C1-INH for prevention of HAE attacks

CSL Behring today announced it has enrolled the first patient in COMPACT, an international phase III study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor oncentrate in patients with frequent hereditary angioedema attacks (NCT01912456).

20 Feb 2014

EMA expands administration options for Hizentra

CSL Behring UK Ltd announced today that the European Medicines Agency (EMA) has expanded the administration options for Hizentra®▼, human normal immunoglobulin, SCIg, 20% liquid, to include dosing once every two weeks (fortnightly).

5 Dec 2013

New smartphone app for patients with hemophilia and related bleeding disorders

BioRx, a national specialty pharmacy and infusion services provider, announced the launch of its industry's first smartphone app designed for patients with hemophilia and related bleeding disorders.

23 Oct 2013

FDA expands Hizentra administration options for people with primary immunodeficiency

CSL Behring announced today that the U.S. Food and Drug Administration has expanded the administration options for Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, to include dosing once every two weeks (biweekly) for people diagnosed with primary immunodeficiency.

28 Sep 2013

Japanese MHLW approves Hizentra for treatment of primary and secondary immunodeficiencies

CSL Behring announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Hizentra (Immune Globulin Subcutaneous [Human]) for the treatment of primary immunodeficiency (PID) and for the treatment of secondary immunodeficiency (SID). Hizentra is now the first and only 20 percent subcutaneous immunoglobulin (SCIg) therapy in the world for the treatment of these conditions, both of which belong to group of rare and serious diseases of the immune system.

27 Sep 2013

Data shows individualized regimens can help optimize prophylaxis treatment in hemophilia patients

Baxter International Inc. today announced data featuring ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], a leading recombinant treatment available worldwide, during the 24th Annual Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Amsterdam, The Netherlands.

From Baxter International Inc. 5 Jul 2013

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

Scientists have shed light on a common bleeding disorder by growing and analysing stem cells from patients' blood to discover the cause of the disease in individual patients.

6 Apr 2013

GZS releases WebTracker-Hemophilia EHR patient registry system

GZS, Inc., a leader in developing disease-specific and condition-specific Electronic Medical Records/Electronic Health Records and patient registry software solutions, has announced the worldwide release of the WebTracker-Hemophilia EHR patient registry solution used under the new brand name HemaGlobal.

2 Apr 2013

FDA approves new vial size for CSL Behring’s Privigen to treat primary immunodeficiency

CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size for Privigen, immune globulin intravenous [human].

21 Feb 2013

Researchers uncover genetic causes of von Willebrand disease

In 2006, the lab of Dr. David Ginsburg at the Life Sciences Institute put a call out for siblings attending the University of Michigan to donate blood for a study of blood-clotting disorders.

10 Jan 2013

Hemostatic testing may explain heavy menstrual bleeding

Results of a US study show that hemostatic screening tests are important in the evaluation of young women with heavy menstrual bleeding.

24 Oct 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

FDA accepts CSL Behring’s 4-factor PCC BLA for standard review

CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of vitamin K-antagonist therapy (i.e., warfarin) in patients with acute major bleeding. If approved by the FDA, the CSL Behring 4-factor PCC would be the first agent of its kind available in the United States.

30 May 2012

Von Willebrand Disease News and Research

Latest Von Willebrand Disease News and Research

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

Baxter seeks FDA approval of BAX 855 for treatment of people with hemophilia A

CSL Behring strengthens global manufacturing capabilities to meet demand for lifesaving therapies

School nurses reach 98% of students in U.S. public schools to diagnose primary immunodeficiency

Baxter reports positive results from BAX 855 Phase 3 trial 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

CSL Behring enrolls first patient in phase III study of C1-INH for prevention of HAE attacks

EMA expands administration options for Hizentra

New smartphone app for patients with hemophilia and related bleeding disorders

FDA expands Hizentra administration options for people with primary immunodeficiency

Japanese MHLW approves Hizentra for treatment of primary and secondary immunodeficiencies

Data shows individualized regimens can help optimize prophylaxis treatment in hemophilia patients

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

GZS releases WebTracker-Hemophilia EHR patient registry system

FDA approves new vial size for CSL Behring’s Privigen to treat primary immunodeficiency

Researchers uncover genetic causes of von Willebrand disease

Hemostatic testing may explain heavy menstrual bleeding

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

FDA accepts CSL Behring’s 4-factor PCC BLA for standard review

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

Von Willebrand Disease News and Research

Latest Von Willebrand Disease News and Research

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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