Swedish Orphan Biovitrum
200 articles with Swedish Orphan Biovitrum
-
Sobi publishes Q1 2022 report
4/28/2022
Swedish Orphan Biovitrum AB announced its report for the first quarter of 2022
-
Sobi to cease ReFacto manufacturing in the first quarter of 2024
3/23/2022
Sobi® announced that its contract with Pfizer for the manufacture of drug substance for ReFacto AF®/Xyntha® has been amended due to clarity of final order volumes and will now expire in the first quarter of 2024, earlier than the previous expiry date at the end of 2025.
-
Efanesoctocog alfa met primary and key secondary endpoints in pivotal study in haemophilia A, demonstrating superiority to prior factor prophylaxis treatment
3/9/2022
Swedish Orphan Biovitrum AB and Sanofi announced positive top-line results from the pivotal XTEND-1 phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa in previously treated patients ≥12 years of age with severe haemophilia A.
-
The XTEND-1 study showed that efanesoctocog alfa met its primary endpoint of clinically meaningful bleed prevention in people ages 12 years and older with severe hemophilia.
-
Efanesoctocog alfa met primary and key secondary endpoints in pivotal study in hemophilia A, demonstrating superiority to prior factor prophylaxis treatment
3/9/2022
Sanofi and Swedish Orphan Biovitrum AB announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa in previously treated patients ≥12 years of age with severe hemophilia A.
-
Gamifant (emapalumab) recommended for approval in China for treatment of primary haemophagocytic lymphohistiocytosis (HLH)
2/25/2022
Sobi® announces that the Center for Drug Evaluation has recommended approval of Gamifant® to the National Medical Products Administration of China.
-
Sobi publishes Q4 and FY 2021 report
2/10/2022
Swedish Orphan Biovitrum AB announces its results for the fourth quarter and full year of 2021.
-
Invitation: Sobi's Q4 and FY 2021 report
2/3/2022
Sobi plans to publish its report for the fourth quarter and full-year 2021 on 10 February 2022 at 08:00 CET.
-
Clinical Catch-Up: December 11-17
12/20/2021
It was an enormously busy week with plenty of announcements from the American Society of Hematology meeting and numerous companies working to get the news out ahead of the holidays and year-end. Here’s a look. -
Aspaveli® (pegcetacoplan) approved in EU as orphan drug for treatment of PNH
12/15/2021
The first targeted C3 therapy approved in the EU Approval based on results from head-to-head PEGASUS phase 3 study where Aspaveli demonstrated superiority to eculizumab in improving haemoglobin levels 1.
-
Apellis and Sobi Announce EU Approval of Aspaveli® (pegcetacoplan) for Treatment of PNH
12/15/2021
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Swedish Orphan Biovitrum AB announced today that the European Commission (EC) has approved Aspaveli® (pegcetacoplan), the first and only targeted C3 therapy, for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who are anemic after treatment with a C5 inhibitor for at least three months.
-
Sobi continues the R&D transformation - Anders Ullman appointed new Head of R&D
12/13/2021
Anders Ullman, M.D., Ph.D., currently a member of the Board of Directors of Sobi, will become Head of R&D and Chief Medical Officer and replace Ravi Rao, M.D., Ph.D.
-
After Sobi agreed to be acquired by Advent International and GIC Special Investments, the deal has fallen through after AstraZeneca withheld its 8% stake from the buyout offer.
-
Sobi and Selecta Biosciences announce completion of enrolment in DISSOLVE Phase 3 study evaluating SEL-212 for chronic refractory gout
12/1/2021
Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO: SOBI) and Selecta Biosciences, Inc. (NASDAQ: SELB), today announced the completion of enrolment for DISSOLVE I, the first of two clinical studies of the phase 3 DISSOLVE development programme of SEL-212 for chronic refractory gout.
-
Apellis and Sobi Receive Positive CHMP Opinion for Aspaveli® (pegcetacoplan) for the Treatment of PNH
10/15/2021
Apellis Pharmaceuticals, Inc. and Swedish Orphan Biovitrum AB announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the marketing authorization of Aspaveli® for the treatment of adults with paroxysmal nocturnal hemoglobinuria who are anemic after treatment with a C5 inhibitor for at least three months.
-
Swedish Orphan Biovitrum AB (Sobi) has received an $8 billion (68 billion kronor) cash buyout offer from Advent International, valuing its shares at SEK 235 each.
-
Invitation - Presentation of Sobi's Q2 2021 results
7/8/2021
On 21 July, at 08:00 CEST, Swedish Orphan Biovitrum AB will publish its report for the second quarter 2021.
-
Sobi to present data at the ISTH 2021 within rare haematology diseases
7/7/2021
Swedish Orphan Biovitrum AB presents data at the virtual ISTH 2021, the 29th Congress of the International Society on Thrombosis and Haemostasis, 17 – 21 July 2021.
-
Sobi at EHA virtual congress 2021: focus on results in PNH and treatment for ITP
6/1/2021
Swedish Orphan Biovitrum AB will present data at the EHA virtual congress, 9-17 June 2021, highlighting the company's advancement of treatments for rare haematological diseases.
-
Positive top-line results from the phase 3 PRINCE study of pegcetacoplan in treatment-naïve patients with PNH
5/25/2021
- Pegcetacoplan demonstrated statistical superiority on the co-primary endpoints of haemoglobin stabilisation (p<0.0001) and reduction in lactate dehydrogenase (LDH) (p<0.0001) compared to standard of care, which did not include complement inhibitors, at week 26 - Mean haemoglobin levels in the pegcetacoplan group increased from 9.4 g/dL to 12.1 g/dL compared to an increase from 8.7 g/dL to 9.4 g/dL on standard of care (p=0.0019)