Senaste nyheterna

28 Mars 2022 16:25

European Medicines Agency Commences Review of Novel Gene Therapy Candidate Etranacogene Dezaparvovec for People with Hemophilia B

Marketing Authorization Application (MAA) for etranacogene dezaparvovec will be reviewed under accelerated assessment and has the potential to be the first gene therapy for patients living with hemophilia B. MAA filing is supported by the phase 3 HOPE-B study which demonstrated durable and sustained therapeutic effect after a single infusion.

4 Februari 2022 16:36

Final Analysis of Pivotal HOPE-B Study Demonstrates Durable and Sustained Therapeutic Effect of Etranacogene Dezaparvovec Gene Therapy in Hemophilia B – Data Presented at EAHAD 2022

Data from the largest gene therapy study in Hemophilia B to date shows that etranacogene dezaparvovec is statistically superior in reducing annualized bleeding rate compared to baseline FIX prophylactic therapy. Following a single administration of etranacogene dezaparvovec, participants maintained stable Factor IX (FIX) activity through 18 months.

15 December 2021 15:17

EMA Grants Accelerated Assessment for CSL Behring’s Haemophilia B Gene Therapy

CSL Behring today announced that the European Medicines Agency has granted its approval for an accelerated assessment request for etranacogene dezaparvovec Marketing Authorisation Application (MAA). Etranacogene dezaparvovec is an investigational gene therapy for people with haemophilia B, a life-threatening bleeding disorder, and is currently being studied in the Phase 3 HOPE-B clinical trial.

30 November 2021 11:00

Dr Vuokko Nummi at Helsinki University Hospital receives the CSL Behring Nordic von Willebrand Scholarship

The CSL Behring Nordic von Willebrand Scholarship is awarded every two years. Dr Vuokko Nummi receives the 2020 scholarship for research on characterization of microcirculation and associations to angiodysplasia in von Willebrand disease.

6 Maj 2021 16:01

CSL Behring Announces Closing of Global Commercialization and License Agreement with uniQure for etranacogene dezaparvovec

Etranacogene dezaparvovec (AMT-061) is an investigational gene therapy that may potentially provide people with hemophilia B with years of functional levels of Factor IX, a blood-clotting protein that prevents excessive bleeding. uniQure will complete the Phase 3 HOPE-B trial and scale up manufacture for initial commercial supply under an agreed plan with CSL Behring.

11 November 2020 10:23

Nytt avsnitt av "Blödigt värre" – Okunskap och fördomar

Vi pratar med tjugotreåriga Sara som lever med den ovanliga blödardiagnosen ITP (immunologisk trombocytopeni) som drabbar cirka 3 av 100 000 personer varje år. Sara berättar om den okunskap hon stött på i livet och hur den påverkat henne.

8 Oktober 2020 10:27

Podcasten "Blödigt värre" firar 20 avsnitt

Under åren har det hunnit bli 20 olika avsnitt där vi lyfter frågor, sprider kunskap och sticker hål på en del fördomar om blödarsjuka. Medverkar gör unga och gamla med blödarsjuka, föräldrar, läkare och forskare för att samtala och söka svar.

Presskontakt

Martin Tenlén

Presskontakt General Manager Nordic Region Talesperson för frågor om CSL Behring Norden. martin.tenlen@cslbehring.com Vxl: +46 (0)8 544 966 70

Fredrik Sjöö, MD, PhD

Presskontakt Head of Medical Affairs Nordic Region Talesperson för medicinska frågor CSL Behring Norden. fredrik.sjoeoe@cslbehring.com +46 (0)8 544 966 85

Petter Olbe

Presskontakt Head of Marketing Nordic Region petter.olbe@cslbehring.com +46 (0)8 544 966 77