Von Willebrand Disease News and Research

Latest Von Willebrand Disease News and Research

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

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

CSL Behring commences C1-INH phase I/II study in hereditary angioedema

CSL Behring announced today that it has initiated an international phase I/II study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in patients with hereditary angioedema.

4 May 2012

CSL Behring commits donations to World Federation of Hemophilia GAP program

To mark World Hemophilia Day 2012, CSL Behring has again committed to making significant financial contributions and donations of clotting factor concentrate to the World Federation of Hemophilia (WFH) Global Alliance for Progress (GAP) program over the period of three years, beginning in 2012. The product donations will be made with medicine having a minimum shelf-life of one year.

17 Apr 2012

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

Albumin best choice for prevention of circulatory dysfunction in cirrhotic patients

Administration of albumin reduces morbidity and mortality in cirrhotic patients undergoing large-volume paracentesis due to severe ascites, according to a new meta-analysis published online today in Hepatology, the official journal of the American Association for the Study of Liver Diseases.

29 Mar 2012

CSL Behring commences enrollment in SCIg PATH trial for CIDP

CSL Behring has announced that the first patient has been enrolled in the PATH study, an international clinical trial designed to evaluate the efficacy, safety, and tolerability of two different doses of subcutaneous immunoglobulin (SCIg), compared with placebo, in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

26 Mar 2012

CSL Behring initiates FCH Phase III trial to control bleeding during cardiovascular surgery

CSL Behring announced today that the first patient has been treated as part of the REPLACE Phase III clinical trial evaluating the efficacy and safety of fibrinogen concentrate (Human) (FCH) in controlling microvascular bleeding during aortic aneurysm surgery.

16 Mar 2012

Timely treatment with Berinert provides faster symptom relief for HAE patients

CSL Behring announced today that treatment with Berinert, C1 Esterase Inhibitor (Human) within six hours of the onset of an acute hereditary angioedema (HAE) attack provides faster symptom relief than later treatment, according to data presented at the 2012 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

7 Mar 2012

Study: Bioavailability similar among four subcutaneous IgG preparations

Data presented by CSL Behring today suggest that the bioavailability of immunoglobulin G (IgG) therapies is consistent when patients with primary immunodeficiencies switch from one IgG product to another by the subcutaneous route.

5 Mar 2012

CSL Behring to receive 2012 EURORDIS Award for pioneering work

CSL Behring is the recipient of a 2012 EURORDIS Award for its pioneering work in developing and manufacturing therapies used to treat rare and serious medical conditions.

2 Mar 2012

Octapharma submits octaplasLG BLA with FDA to treat TTP

Octapharma USA has submitted its Biological License Application (BLA) for octaplasLG to the U.S. Food and Drug Administration (FDA) with the goal of expanding its U.S. product portfolio by the fourth quarter of 2012.

28 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

Baxter commences BAX 855 Phase I trial in hemophilia A

Baxter International Inc. today announced the dosing of the first patients in a Phase I clinical trial of its lead investigational candidate, BAX 855, a longer-acting (PEGylated) form of a full-length recombinant factor VIII (rFVIII) protein.

From Baxter International Inc. 5 Jan 2012

FDA approves CSL Behring's Berinert for treatment of HAE attacks

CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for self-administration of Berinert, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute attacks of hereditary angioedema (HAE), a rare and potentially fatal genetic disorder.

4 Jan 2012

Baxter receives FDA approval for ADVATE to prevent hemophilia A

Baxter International Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A.

From Baxter International Inc. 17 Dec 2011

American Plasma Users Coalition awarded $40,000 advocacy grant from CSL Behring

CSL Behring announced today that it has awarded a $40,000 advocacy grant to the American Plasma Users Coalition (A-PLUS) through its Local Empowerment for Advocacy Development (LEAD) program. LEAD grants support the grassroots advocacy efforts of organizations that help people who use plasma-derived or recombinant therapies to manage rare and serious medical disorders.

3 Dec 2011

ASH recognizes abstract presenters at 53rd annual meeting in San Diego

The American Society of Hematology (ASH) recognizes the following abstract presenters at the 53rd ASH annual meeting in San Diego, CA, with the highest scoring abstracts in the categories of undergraduate student, medical student, graduate student, resident physician, and postdoctoral fellow.

2 Dec 2011

Octapharma receives FDA approval for octagam to treat disorders of immune system

The U.S. Food and Drug Administration (FDA) yesterday cleared the way for the U.S. market return of octagam, the Octapharma USA product used to treat disorders of the immune system.

5 Nov 2011