FierceBiotech

FDA Approves Baxter's RIXUBIS as First Recombinant Factor IX Treatment for Routine Prophylaxis of Hemophilia B

Approval brings patients first new rFIX treatment option in more than 15 years DEERFIELD, Ill.--June 27, 2013--Baxter International Inc. (NYSE:BAX) today announced that the United States Food and Drug ...
Medical News Today

Your guide to treatment options for hemophilia B

Hemophilia B causes a deficiency in factor IX, a protein necessary for blood clotting. Replacement factor IX therapy is the gold standard treatment, but novel and genetic therapies are showing promise ...
FiercePharma

CSL Behring Presents Phase III Data for Its Long-Acting Recombinant Factor IX Albumin Fusion Protein for Hemophilia B at the 57th ASH Annual Meeting & Exposition

ORLANDO, Fla., Dec. 7, 2015 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today presented data from its Phase III PROLONG-9FP clinical program evaluating the efficacy and long-term safety ...
The New England Journal of Medicine

Phase 3 Study of Recombinant Factor IX Fc Fusion Protein in Hemophilia B

Prophylactic factor replacement in patients with hemophilia B improves outcomes but requires frequent injections. A recombinant factor IX Fc fusion protein (rFIXFc) with a prolonged half-life was ...
FiercePharma

U.S. FDA Approves CSL Behring's IDELVION® -- The First and Only Hemophilia B Therapy with Up to 14-day Dosing Intervals

KING OF PRUSSIA, Pa., March 4, 2016 /PRNewswire/ -- CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved IDELVION® [Coagulation Factor IX (Recombinant), Albumin ...
The American Journal of Managed Care

New Recombinant Factor IX Leads to Significant Cost Savings in Hemophilia B

The projected cost reductions held both for patients switching from a different extended-half-life product and for patients switching from a standard-half-life product. Switching patients with ...
Business Wire

Biovitrum and Syntonix Enter Agreement for the Joint Development and Commercialization of Recombinant Factor IX for the Treatment of Hemophilia

STOCKHOLM, Sweden--(BUSINESS WIRE)--Jan. 23, 2006--Biovitrum AB, Sweden, and Syntonix Pharmaceuticals, Inc., USA, have entered into a co-development and commercialization agreement for Syntonix' ...
Nasdaq

IDELVION® Becomes First and Only Factor IX Therapy with 21-Day Prophylactic Dosing

HATTERSHEIM, Germany, July 3, 2020 /PRNewswire/ -- Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) has approved the new Summary of Product ...
FierceBiotech

FDA approves first long-acting recombinant coagulation Factor IX concentrate for patients with Hemophilia B

The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first ...
Kaleido Scope

Factor IX Deficiency

Following are specific recommended plasma levels and actions for common bleeding problems and clinical situations which occur with Hemophilia B, also known as Factor IX Deficiency: Assess situation ...
Monthly Prescribing Reference

Phase 3 Study Update of Recombinant Factor IX FC Fusion Protein for Hemophilia B

Biogen Idec and Swedish Orphan Biovitrum (Sobi) announced positive results from B-LONG, a global, open-label, multi-center Phase 3 clinical study that evaluated the efficacy, safety and ...