• Facebook
  • Twitter
  • LinkedIn
  • Google +
  • RSS

Swedish Orphan Biovitrum (SOBI) - Articles and news items

orfadin

FDA approves higher strength Orfadin capsule for HT-1

Industry news / 15 June 2016 / Victoria White, Digital Content Producer

The FDA has approved a higher strength 20mg capsule of Sobi’s Orfadin (nitisinone) for the treatment of Hereditary Tyrosinaemia type-1 (HT-1)…

haemophilia B

EC approves Alprolix for the treatment of haemophilia B

Industry news / 13 May 2016 / Victoria White, Digital Content Producer

The European Commission has approved Alprolix (rFIXFc) for the treatment of haemophilia B and maintained its orphan designation…

haemophilia B

CHMP adopts positive opinion of haemophilia B treatment, Alprolix

Industry news / 26 February 2016 / Victoria White

Alprolix is a recombinant clotting factor therapy developed for haemophilia B by fusing factor IX to the Fc portion of immunoglobulin G subclass 1…

elocta

EC gives nod to haemophilia A treatment Elocta

Industry news / 26 November 2015 / Victoria White

Elocta will be the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days…

elocta

CHMP recommends Elocta for haemophilia A

Industry news / 25 September 2015 / Victoria White

Elocta is a recombinant factor VIII Fc fusion protein product that, if approved, would be the first haemophilia A treatment with prolonged circulation available in the EU…

alprolix

B-YOND study results reinforce long-term clinical profile of Alprolix

Industry news / 18 August 2015 / Victoria White

Interim results from the B-YOND study support the long-term safety and efficacy of Alprolix in people with severe haemophilia B treated for up to two years…

Orfadin

European Commission approves Orfadin oral suspension

Industry news / 29 June 2015 / Victoria White

The European Commission (EC) has approved the oral suspension formulation of Sobi’s Orfadin for the treatment of Hereditary Tyrosinaemia type-1 (HT-1)…

alprolix

European Medicines Agency validates Alprolix marketing authorisation application

Industry news / 26 June 2015 / Victoria White

Biogen and SOBI have announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for Alprolix…

Biogen Idec logo

Leading hematology journal publishes pivotal ELOCTATE™ data that demonstrated efficacy and safety of investigational long-lasting therapy for hemophilia A

Industry news / 13 November 2013 / Biogen Idec

Phase 3 study showed potential for once- or twice-weekly prophylactic dosing regimens…

Biogen Idec logo

New Phase 3 data reinforce long-lasting protection from bleeding for patients with Hemophilia A and B

Industry news, News / 8 February 2013 / Biogen Idec

Biogen Idec and Swedish Orphan Biovitrum released data…

Biogen Idec logo
Biogen Idec logo

Biogen Idec and SOBI initiate global clinical trials of long-lasting hemophilia A and B product candidates in children

Industry news, News / 5 July 2012 / Biogen Idec

Biogen Idec and SOBI announced the initiation of two global pediatric clinical trials…

 

Webinar: Different thermal analysis techniques to measure the glass transitionWATCH NOW
+ +