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21-Jan-2016 - Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that the European Patent Office (EPO) has decided to grant a European patent for the Orfadin® (nitisinone) oral suspension formulation, which was approved by the European Commission for the treatment of Hereditary Tyrosinaemia type-1 ...
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 ...
23-Dec-2014 - Swedish Orphan Biovitrum AB and partner Auxilium Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the use of Xiapex® (collagenase clostridium histolyticum) for the treatment of ...
10-Jan-2013 - Sobi announced that the US Food and Drug Administration (FDA) has approved Kineret® (anakinra) for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID). Kineret® is the FDA-approved therapy for NOMID, the most severe form of cryopyrin associated ...
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 ...
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 ...
05-Jun-2012 - Birgitte Volck has been appointed Senior Vice President, Chief Medical Officer at Sobi with responsibility for Clinical Development, Regulatory Affairs, Drug Safety and Medical Affairs.Birgitte Volck is currently Executive Development Director, Bone, Neuroscience & Inflammation at Amgen Limited ...
03-Apr-2012 - Sobi has amended its share purchase agreement regarding the acquisition in 2005 of the pharmaceutical company Arexis AB, which included a number of development programs.According to the amended agreement, Sobi will not have any remaining development obligations towards the sellers. In addition, ...
02-Feb-2012 - Wills Hughes-Wilson has been appointed Vice President, Government Affairs & Policy with responsibility for Sobi's contacts with all stakeholders in the health policy area.Wills comes from Genzyme Corporation, now part of the French Sanofi Group, where she was Vice President Health/Market Access ...
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