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17-Apr-2015 - Swedish Orphan Biovitrum AB has received orphan drug designation in Switzerland for its long acting haemophilia drug candidate Elocta (rFVIIIFc) developed for the treatment of haemophilia A. An orphan drug designation is to encourage the development of medicines for rare diseases and provides ...
04-Mar-2015 - Biogen Idec and Swedish Orphan Biovitrum AB announced positive top-line results of the Kids B-LONG Phase 3 clinical study that evaluated the safety, efficacy and pharmacokinetics of Alprolix® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] in children under age 12 with severe haemophilia ...
27-Nov-2014 - Apitope announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has granted orphan medicinal product designation to ATX-F8-117 for the treatment of haemophilia A.Haemophilia A is a rare chronic bleeding disorder which leads to inadequate clotting of the ...
01-Apr-2014 - Using a new gene-editing system based on bacterial proteins, MIT researchers have cured mice of a rare liver disorder caused by a single genetic mutation. The findings, described in Nature Biotechnology, offer the first evidence that this gene-editing technique, known as CRISPR, can reverse ...
Benefits continue to outweigh risks in previously untreated patients
03-Jan-2014 - The European Medicines Agency’s Committee on Human Medicinal Products (CHMP) has endorsed recent recommendations which concluded that the benefits of Kogenate Bayer and Helixate NexGen, so-called second generation factor VIII products, continue to outweigh their risks in previously untreated ...
Current evidence does not confirm increased risk of inhibitor development compared with other factor VIII products
10-Dec-2013 - The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the medicines Kogenate Bayer and Helixate NexGen and concluded that current evidence did not confirm an increased risk of developing antibodies (factor VIII inhibitors) against these medicines when ...
11-Mar-2013 - An Australian researcher has found the third and final missing piece in the genetic puzzle of an unusual form of hemophilia, more than 20 year after he discovered the first two pieces. Professor Merlin Crossley, of the University of New South Wales, and his international team studied the ...
28-Sep-2012 - Biogen Idec and Swedish Orphan Biovitrum (Sobi)announced positive results from B-LONG, a clinical study that evaluated a new long-lasting clotting factor candidate in people with hemophilia B. Hemophilia B is a rare inherited disorder that impairs blood coagulation.Top-line results from B-LONG, a ...
13-Sep-2012 - Pro Bono Bio Group plc announced the successful conclusion of a series of pre-clinical trials in haemophiliac subjects conducted with the world’s first long acting blood Factors VIIa, VIII and IX capable of subcutaneous administration. The results of these trials are of great importance as these ...
09-Jul-2012 - Biogen Idec and Swedish Orphan Biovitrum announced the initiation of two global pediatric clinical trials of the companies' long-lasting recombinant Factor VIII and Factor IX Fc fusion proteins (rFVIIIFc and rFIXFc) in hemophilia A and B.rFVIIIFc and rFIXFc are fully-recombinant clotting factors ...
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