Tag Archives: Hemophilia B

November, 2018

November, 2017

  • 27 November

    FDA Updates Label for Alprolix, Adding Long-Term Safety and Efficacy Data

    WALTHAM, Mass.–(BUSINESS WIRE)–Bioverativ Inc. (NASDAQ: BIVV), a global biopharmaceutical company dedicated to transforming the lives of people with rare blood disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the leading extended half-life therapy for the …

September, 2017

June, 2017

  • 1 June

    FDA Approves New Novo Nordisk Hemophilia B Treatment

    PLAINSBORO, N.J., May 31, 2017 /PRNewswire/ — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B. Hemophilia B is a chronic and inherited bleeding …

May, 2017

April, 2017

  • 7 April

    Spark’s Hemophilia B Candidate Demonstrates Positive Early-Stage Data

    PHILADELPHIA, April 06, 2017 (GLOBE NEWSWIRE) — Spark Therapeutics (NASDAQ:ONCE) announced updated preliminary data today from 10 infused participants in the ongoing Phase 1/2 clinical trial of investigational SPK-9001 for hemophilia B. All participants have experienced consistent and sustained increases in factor IX activity following administration of the investigational therapy. …

January, 2017

March, 2016

  • 7 March

    CSL’s Idelvion Approved for Treatment of Hemophilia B

    KING OF PRUSSIA, Pa. — 04 March 2016 In clinical trials, IDELVION maintained factor IX activity levels above 5 percent over 14 days, resulting in a median annualized spontaneous bleeding rate (AsBR) of 0.00 IDELVION, CSL Behring’s long-acting recombinant albumin fusion protein, delivers on the company’s promise to develop and …

April, 2015

  • 14 April

    World Hemophilia Day

    Around the world, approximately one out of every one hundred people has a bleeding disorder, which includes hemophilia, as well as lesser-known bleeding disorders such as von Willebrand disease and factor XI deficiency. Many of these people (especially women with von Willebrand disease) have no idea about their condition. World …