Swedish Orphan Biovitrum
219 articles with Swedish Orphan Biovitrum
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Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout Meets Primary Endpoint: Swedish Orphan Biovitrum AB
3/21/2023
Selecta Biosciences, Inc. and Sobi®, announced positive topline results from the Phase 3 DISSOLVE I & II placebo controlled randomized clinical trials to determine safety and efficacy of two different dose levels of SEL-212 in adult patients with chronic refractory gout.
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Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout Meets Primary Endpoint
3/21/2023
Selecta Biosciences, Inc. and Sobi®, announced positive topline results from the Phase 3 DISSOLVE I & II placebo controlled randomized clinical trials to determine safety and efficacy of two different dose levels of SEL-212 in adult patients with chronic refractory gout.
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Positive topline results from pivotal XTEND-Kids phase 3 study of efanesoctocog alfa in children under 12 years of age with haemophilia A: Swedish Orphan Biovitrum AB
3/2/2023
Sobi® and Sanofi announced that the XTEND-Kids phase 3 pivotal study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa as once-weekly prophylaxis in previously treated patients under 12 years of age with severe haemophilia A met its primary endpoint.
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Sobi publishes Q4 and FY 2022 report: a good year and a solid future
2/8/2023
Swedish Orphan Biovitrum AB announced its report for the fourth quarter and full year of 2022
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Changes to Sobi's management - February 02, 2023
2/2/2023
Anton Hoos, M.D., Ph.D., MBA will become Head of R&D and Medical Affairs and Chief Medical Officer and replace Anders Ullman, M.D., Ph.D. who will retire.
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ADC Therapeutics and Sobi Announce European Commission Approval of ZYNLONTA® (loncastuximab tesirine) for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
12/21/2022
ADC Therapeutics SA and Swedish Orphan Biovitrum AB announced the European Commission has granted conditional marketing authorization for the use of ZYNLONTA® for the treatment of relapsed or refractory diffuse large B-cell lymphoma.
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Sobi to present new data at the ASH 2022 Annual Meeting
11/11/2022
Sobi® will present new data at the 64th Annual Meeting of the American Society of Hematology taking place from 10 to 13 December 2022.
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U.S. Food and Drug Administration Issues Emergency Use Authorization for KINERET® (anakinra) for the Treatment of COVID-19-Related Pneumonia
11/10/2022
Sobi North America announced that the U.S. FDA issued an emergency use authorization for KINERET® for the treatment of COVID-19 in adult patients who are hospitalized with positive results of direct SARS-CoV-2 viral testing with pneumonia, requiring supplemental oxygen, and are at risk of progressing to severe respiratory failure, and are likely to have an increased blood level of a certain suPAR that may be a sign of increased risk of worsening of the disease.
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Swedish Orphan Biovitrum AB (publ)'s Chairman of the Board Håkan Björklund will not be available for re-election at the Annual General Meeting 2023
10/31/2022
Håkan Björklund, the current Chairman of the Board of Swedish Orphan Biovitrum AB, has notified the Nomination Committee that he is not available for re-election at the Annual General Meeting 2023.
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Sobi publishes Q3 2022 report
10/27/2022
Swedish Orphan Biovitrum AB announced its report for the third quarter of 2022.
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Sobi to Present Data from REAL-HLH Study at the ACR Convergence 2022 MeetingData presented from the REAL-HLH study; the first study of patients treated with Gamifant in a real-world clinical setting
10/27/2022
Sobi North America announced a presentation from the REAL-HLH study – a chart review study which assessed real-world treatment patterns and outcomes in patients with hemophagocytic lymphohistiocytosis who were treated with Gamifant® – at the American College of Rheumatology Convergence 2022 Meeting taking place in Philadelphia from November 10-14, 2022.
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New number of shares and votes in Swedish Orphan Biovitrum AB (publ)
9/30/2022
As per 30 September 2022, the total number of shares in Swedish Orphan Biovitrum AB amounts to 309,804,782 shares.
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ADC Therapeutics and Sobi Announce ZYNLONTA® (loncastuximab tesirine) Receives Positive CHMP Opinion in Europe for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
9/16/2022
ADC Therapeutics SA (NYSE: ADCT) and Swedish Orphan Biovitrum AB (Sobi®) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorization of ZYNLONTA® (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
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Sobi publishes Q2 2022 report
7/19/2022
Swedish Orphan Biovitrum AB announced its report for the second quarter of 2022
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Sanofi announced positive data for its therapeutic, fitusiran, for treating patients with hemophilia A and B, as well as efanesoctocog alfa therapy for treating hemophilia A.
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Press Release: Pivotal data demonstrate once-weekly efanesoctocog alfa provides superior bleed protection compared to prior factor prophylaxis
7/10/2022
Sanofi and Swedish Orphan Biovitrum AB presented for the first time , in a late-breaking session at the 30thInternational Society on Thrombosis and Haemostasis Congress, positive results from the XTEND-1 pivotal Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa, an investigational factor VIII replacement therapy, in previously treated adults and adolescents ≥12 years with severe hemophilia A.
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Sobi to license loncastuximab tesirine from ADC Therapeutics
7/8/2022
Sobi® announced an exclusive license agreement with ADC Therapeutics SA to develop and commercialise loncastuximab tesirine for use in haematology and other indications of large unmet medical need in Europe and most international markets.
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ADC Therapeutics Announces Exclusive License Agreement with Sobi to Develop and Commercialize ZYNLONTA® (loncastuximab tesirine-lpyl) in Europe and Select International Territories
7/8/2022
ADC Therapeutics SA announced it has entered into an exclusive license agreement with Swedish Orphan Biovitrum AB for the development and commercialization of ZYNLONTA® for all hematologic and solid tumor indications outside of the United States, greater China, Singapore and Japan.
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At ENDO 2022, Ascendis will share Phase II and III data showing clinical efficacy for its investigational product candidate for hypoparathyroidism. For this and more, see inside.
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Sobi publishes Q1 2022 report
4/28/2022
Swedish Orphan Biovitrum AB announced its report for the first quarter of 2022