Nyhetsarkiv

The National “New Methods” Decision Forum in Norway recommends CSL’s gene therapy HEMGENIX® for adults with severe or moderately severe haemophilia B without a history of Factor IX inhibitors

17 Mars 2026 08:25

The National “New Methods” decision forum in Norway yesterday announced a positive recommendation for the reimbursement of HEMGENIX® (etranacogene dezaparvovec) for the treatment of patients with the rare blood clotting disorder haemophilia B, paving the way for the finalization of a commercial contract with Sykehusinnkjøp, the Norwegian procurement authority.

ANDEMBRY (garadacimab) får subvention för förebyggande av återkommande HAE-anfall vid svår sjukdom

28 Januari 2026 09:11

Tandvårds- och läkemedelsförmånsverket (TLV) har meddelat att ANDEMBRY® ska ingå i läkemedelsförmånerna från och med den 1 februari 2026. Subventionen är begränsad till rutinmässig prevention av recidiverande anfall av hereditärt angioödem (HAE) hos patienter i åldern 12 år och äldre med svår sjukdomsbild och minst fyra HAE-anfall i månaden.

Data Published in the New England Journal of Medicine Confirm the Long-term Durability and Safety of HEMGENIX® (etranacogene dezaparvovec) Over Five Years

9 December 2025 08:31

Global biopharma leader CSL (ASX:CSL) today announced five-year (60-month) results from the pivotal Phase 3 HOPE-B study, confirming the long-term durability and safety of a one-time infusion of HEMGENIX® (etranacogene dezaparvovec) in adults living with moderate to severe haemophilia B. Published in the New England Journal of Medicine (NEJM).

Nya terapier kräver nya betalningsmodeller – CSL deltar vid New Horizons in Biologics & Bioprocessing i Stockholm

4 December 2025 08:57

Sverige ligger under EU-snittet i patienters tillgång till behandlingar för sällsynta sjukdomar och patienter i 20 europeiska länder har tillgång till fler särläkemedel. Resultatbaserade avtal där betalning kopplas till faktisk klinisk effekt kan minska ekonomiska risker och samtidigt bidra till kostnadsbesparingar och effektivare vård. Flera länder, som Danmark, har redan infört sådana modeller.

CSL Behring’s Gene Therapy HEMGENIX (etranacogene dezaparvovec): Four Years Post-Infusion Data Continue to Show Sustained Efficacy and Safety in Adults with Haemophilia B

11 Februari 2025 08:34

94% of patients eliminated factor IX prophylaxis and remained free of continuous prophylaxis through four years post-treatment. Mean factor IX activity levels were sustained at near normal levels of 37% through four years post-treatment, reinforcing the efficacy of HEMGENIX® in the treatment of haemophilia B.

CSL Behring Appoints Helena Bragd as New General Manager for the Nordic Region

28 Januari 2025 08:31

Helena Bragd is the new General Manager of CSL Behring Nordic Region – Sweden, Denmark, Norway, Finland, and Iceland. CSL Behring is a global biotherapeutics leader driven by our promise to save lives.

First patients treated with HEMGENIX® (etranacogene dezaparvovec) gene therapy for haemophilia B in Denmark

21 Januari 2025 08:26

CSL Behring Denmark today announced that the first Danish patients with haemophilia B were treated with the gene therapy HEMGENIX® (etranacogene dezaparvovec). HEMGENIX® is the first one-time gene therapy to be approved in Europe for the treatment of adults with severe and moderately severe haemophilia B.

CSL Behring Signs Milestone Commercial Agreement with Amgros to Fund Haemophilia B Gene Therapy HEMGENIX in Denmark

29 Oktober 2024 09:34

CSL Behring today announced that an outcome-based agreement has been reached with Amgros, the Danish procurement authority, for the national reimbursement of HEMGENIX® in Denmark. Denmark is the first country in the Nordic region to reimburse HEMGENIX® under such a performance-based model, in which the regions only incur costs if the gene therapy proves effective over an agreed long-term period.

The Danish Medicines Council recommends CSL Behring’s gene therapy HEMGENIX® for adults with severe or moderately severe haemophilia B

25 Juni 2024 08:33

CSL Behring today announced that a positive recommendation for reimbursement of HEMGENIX has been released by the Danish Medicines Council for the treatment of patients with rare blood clotting disorder, haemophilia B opening the way to finalize a commercial contract with Amgros, the Danish procurement authority.1 Denmark is the first country in the Nordics to reimburse HEMGENIX.

CSL Behring uppmärksammar Världshemofilidagen och alla som lever med blödarsjuka

15 April 2024 08:57

Den 17 april är det Världshemofilidagen som i år har fokus på rättvis tillgång till behandling för alla med blödarsjuka. CSL Behring är ett globalt bioteknikföretag som drivs av löftet att rädda och förbättra människors liv. Forskningen inom hemofili har gjort stora framsteg under de senaste åren som har lett till nya behandlingsformer.

CSL's Garadacimab, a First-in-Class Factor XIIa Inhibitor, Receives FDA and EMA Filing Acceptance

15 December 2023 13:45

These regulatory milestones bring CSL one step closer to delivering on our promise to patients with a first-in-class recombinant monoclonal antibody for people living with HAE, a community CSL has been serving for over 40 years, in the US and European Union.

The Lancet Publishes Pivotal Phase 3 Data on CSL's First-in-Class Garadacimab for HAE

13 April 2023 10:23

Significant reduction in number of attacks support the potential of once-monthly garadacimab as a prophylactic therapy for patients with hereditary angioedema.