New Market - May 19, 2017
Sobi’s Elocta approved in Saudi Arabia
Swedish Orphan Biovitrum announces that the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia has approved Elocta (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of haemophilia A. Elocta is the first extended half-life and recombinant factor VIII Fc fusion protein therapy approved […]
In a new job - April 15, 2017
Guido Oelkers appointed President and CEO at Sobi
Swedish Orphan Biovitrum announces that Guido Oelkers has been appointed President and Chief Executive Officer effective as of 22 May 2017, succeeding Geoffrey McDonough. Guido Oelkers joins Sobi from his previous role as CEO at BSN Medical GmbH. He has extensive experience from pharmaceutical and health care companies including a role as President and CEO […]
Drug Development Pharma - March 7, 2017
Sobi receives FDA approval for Orfadin capsules
Swedish Orphan Biovitrum announces that FDA has approved in-use storage at room temperature (25°C or less) for up to 45 days for all strengths of Orfadin capsules. The FDA approval follows the already existing approval by the European Medicines Agency (EMA) for in-use storage at room temperature. In addition to this, FDA also approved an […]
Drug Development Pharma - March 2, 2017
Sobi receives approval from the EMA
Swedish Orphan Biovitrum has received approval from the European Medicines Agency (EMA) for the grouped type II 15 K Variation for Elocta (efmoroctocog alfa). The variation involves several changes, including the approval of Elocta drug substance manufacturing in 15 000 litre scale bioreactors. Elocta is a recombinant extended half-life factor VIII Fc fusion protein product for […]
Agreement - February 22, 2017
Sobi enters distribution agreement
Swedish Orphan Biovitrum (Sobi) announces that the company has entered into a 3-year agreement with Valeant Pharmaceuticals Ireland for the distribution of Ammonul (sodium phenyl acetate and sodium benzoate) injection in Europe, the Middle East and North Africa. The new agreement replaces the current distribution agreement with Valeant Pharmaceuticals North America LLC for the same […]
Clinical Trials - February 7, 2017
Sobi announces new results from Phase 3 clinical trial
Swedish Orphan Biovitrum (Sobi) and Bioverativ have announced that results from the Kids B-LONG Phase 3 clinical trial, which studied Alprolix in previously-treated children with severe haemophilia B. The primary outcome measure of the trial was development of inhibitors, and no patients treated with Alprolix in the study developed inhibitors. Treatment was generally well tolerated […]
