Pharmaceuticals, Biotechnology and Life Sciences
Sobi has announced that the National Medical Products Administration of China (NMPA) has approved Gamifant (emapalumab) for use in China. The indication is for treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.
Swedish Orphan Biovitrum (SOBI) and Sanofi have announced positive top-line results from the pivotal XTEND-1 phase 3 study evaluating the…
Sobi has announce that the Center for Drug Evaluation (CDE) has recommended approval of Gamifant to the National Medical Products…
EMA’s human medicines committee (CHMP) has recommended extending the indication of Kineret (anakinra) to include treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml.
Republic of Ireland’s Health Service Executive (HSE) and Sobi have signed a supply deal to offer people with with haemophilia haemophilia…
Swedish Orphan Biovitrum AB (publ) (Sobi) has appointed Norbert Oppitz as Senior Vice President for the newly established business area Specialty Care.
Swedish Orphan Biovitrum (Sobi) will open a new office in Athens, Greece.
Swedish Orphan Biovitrum AB known as Sobi said Tuesday that the FDA has approved increased shelf life and extended out-of-refrigeration for Orfadin capsules.
Swedish Orphan Biovitrum (Sobi) has received approval from the European Medicines Agency (EMA) for the grouped type II 15 K Variation for Elocta (efmoroctocog alfa), recombinant extended half-life factor VIII Fc fusion protein product for the treatment of haemophilia A.
Swedish Orphan Biovitrum (Sobi) has elected to add a novel product candidate (rFIXFc-XTEN) for the potential treatment of haemophilia B to the company’s collaboration agreement with Bioverativ.