Pharma Business - April 29, 2016
Sobi signs agreement with Pfizer
Swedish Orphan Biovitrum (Sobi) has extended the existing manufacturing agreement with Pfizer for the drug substance for ReFacto AF/XYNTHA until December 31, 2023. The drug substance will continue to be manufactured in Sobi’s GMP biologics facility in Stockholm. In addition, Sobi has decided to move production of Kineret drug substance to Pfizer’s manufacturing site in […]
Pharma Business - March 29, 2016
Transfer of marketing authorisation for Elocta to Sobi approved
The European Commission has approved the transfer of the marketing authorisation for Elocta® (efmoroctocog alfa) from Biogen to Sobi, making Sobi the marketing authorisation holder of Elocta in the EU. Elocta is a recombinant human factor VIII Fc fusion protein with an extended half-life and is the first haemophilia A treatment in the EU to […]
Clinical Trials - February 15, 2016
Sobi initiates clinical programs and receives US patent
Swedish Orphan Biovitrum has announced that it has decided to initiate two clinical programs with Kineret (anakinra) in North America, with the aim of evaluating two new potential indications for Kineret where a significant need for alternative treatment options exists: acute gout and Still’s disease. An increasing body of evidence suggests the potential involvement of interleukin-1 […]
Intellectual Property - January 17, 2016
Sobi’s Orfadin granted European patent
Swedish Orphan Biovitrum yesterday 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 (HT-1) in 2015. HT-1 is a rare genetic disease that affects infants and children. It is progressive […]
In a new job - January 14, 2016
Birgitte Volck to leave Sobi for GSK
Swedish Orphan Biovitrum has announced that Birgitte Volck, M.D., Ph.D., Senior Vice President of Development and Chief Medical Officer (CMO) of Sobi, will leave the company to join the rare disease research group at GlaxoSmithKline as Head of R&D Rare Diseases. Birgitte will work through a six month notice period before leaving Sobi. “We thank Birgitte […]
Pharma Business - January 12, 2016
Sobi launches Elocta in first countries in Europe
Swedish Orphan Biovitrum AB has announced the commercial launch of Elocta (efmoroctocog alfa) in first countries in Europe. Elocta is a recombinant human factor VIII Fc fusion protein with an extended half-life, and is the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to […]
