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RSS FeedPosted by Michael Wonder on 26 Sep 2024
Health Canada grants marketing authorisation of first CRISPR/Cas9 gene edited therapy, Casgevy (exagamglogene autotemcel), for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
25 September 2024 - First regulatory authorisation of a CRISPR-based gene-editing therapy in Canada. ...
Posted by Michael Wonder on 03 Apr 2024
Vertex announces new drug submission for exagamglogene autotemcel (exa-cel) has been accepted for priority review by Health Canada for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
1 April 2024 - Exa-cel is the first CRISPR-based gene-edited therapy to be submitted for Health Canada review. ...
Posted by Michael Wonder on 21 Mar 2024
Health Canada accepts for review new drug submission for tofersen for treatment of rare, genetic form of ALS
19 March 2024 - Health Canada regulatory decision on tofersen new drug submission expected in early 2025. ...
Posted by Michael Wonder on 04 Jan 2024
Health Canada approves Pfizer Canada's gene therapy in haemophilia B
3 January 2024 - Pfizer Canada announced that Health Canada approved Beqvez (fidanacogene elaparvovec), an adeno-associated viral vector-based gene therapy for ...
Posted by Michael Wonder on 27 Oct 2023
Health Canada authorises CSL's Hemgenix (etranacogene dezaparvovec) as first gene therapy for haemophilia B
26 October 2023 - CSL's Hemgenix is a one time, single dose treatment for adults with haemophilia B who require ...
Posted by Michael Wonder on 16 Dec 2020
Health Canada approves Zolgensma, the one-time gene therapy for paediatric patients with spinal muscular atrophy
16 December 2020 - Zolgensma is designed to address the genetic root cause of SMA by replacing the missing or defective ...
Posted by Michael Wonder on 15 Oct 2020
Health Canada approves first-ever gene replacement therapy, Luxturna
15 October 2020 - Luxturna (voretigene neparvovec), is the first approved therapy for previously untreatable inherited retinal disease. ...
Posted by Michael Wonder on 24 Jul 2019
Alnylam launches Onpattro (patisiran) for the treatment of polyneuropathy in hATTR amyloidosis, the first-ever RNAi therapeutic approved in Canada
23 July 2019 - Onpattro is the only treatment that demonstrated improvement, relative to baseline, in both polyneuropathy and quality ...
Posted by Michael Wonder on 05 Oct 2018
Akcea and Ionis announce approval of Tegsedi (inotersen injection) in Canada
4 October 2018 - First and only treatment of its kind for Canadians with hereditary transthyretin-mediated amyloidosis with polyneuropathy – a ...
Posted by Michael Wonder on 25 Sep 2018
Alnylam Pharmaceuticals receives priority review in Canada for patisiran, an investigational RNAi therapeutic for the treatment of hereditary transthyretin-mediated amyloidosis with polyneuropathy
24 September 2018 - Health Canada grants priority review to promising medicines intended for the treatment of serious, debilitating or life-threatening ...
Posted by Michael Wonder on 05 Jul 2017
Biogen's Spinraza (nusinersen) receives Notice of Compliance from Health Canada for the treatment of 5q spinal muscular atrophy
4 July 2017 - First SMA treatment approval in Canada. ...