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RSS FeedPosted by Michael Wonder on 13 Apr 2023
Vertex announces Health Canada market authorisation for Orkambi (lumacaftor/ivacaftor) in children with cystic fibrosis ages 1 to <2 years
10 April 2023 - With this approval, approximately 30 children with two copies of the F508del mutation are eligible for ...
Posted by Michael Wonder on 04 Apr 2023
Chiesi Global Rare Diseases announces approval of Ferriprox MR deferiprone extended release tablets in Canada
31 March 2023 - New formulation allows twice-daily dosing in patients with transfusional iron overload due to thalassaemia syndromes when ...
Posted by Michael Wonder on 27 Mar 2023
Kite's Yescarta (axicabtagene ciloleucel) first CAR T-cell therapy to receive Health Canada authorisation for use in second-line large B-cell lymphoma
23 March 2023 - Landmark ZUMA-7 study demonstrated patients on Yescarta were 2.5 times more likely to be alive at ...
Posted by Michael Wonder on 27 Mar 2023
Health Canada authorises Imbruvica (ibrutinib) in a fixed duration combination with venetoclax for adult patients with previously untreated chronic lymphocytic leukaemia
23 March 2023 - All oral, once daily, fixed duration combination regimen authorised for first-line treatment of CLL. ...
Posted by Michael Wonder on 27 Mar 2023
Columvi (glofitamab for injection) receives Health Canada authorisation with conditions for adult patients with relapsed or refractory diffuse large B-cell lymphoma
25 March 2023 - Authorization is based on results from the Phase 1/2 NP30179 study, which demonstrated Columvi induced durable response ...
Posted by Michael Wonder on 27 Mar 2023
Health Canada approves first treatment option for generalised pustular psoriasis flares in adults
24 March 2023 - In the EFFISAYIL-1 trial, over half of the Spevigo (spesolimab) treated patients were free of pustules, ...
Posted by Michael Wonder on 19 Feb 2023
Health Canada authorises Moderna's Omicron targeting bivalent COVID-19 vaccine in children & adolescents (6-17 years)
17 February 2023 - The recommendation is based on clinical data for Moderna's bivalent Omicron targeting COVID-19 vaccine, mRNA.1273.214. ...
Posted by Michael Wonder on 11 Feb 2023
Health Canada approves Adtralza (tralokinumab) for the treatment of adolescents aged 12 to 17 with moderate to severe atopic dermatitis
8 February 2023 - Adtralza is the first treatment for adolescents with moderate to severe atopic dermatitis specifically targeting the ...
Posted by Michael Wonder on 18 Jan 2023
Ultomiris approved in Canada for adults with generalied myasthenia gravis
17 January 2023 - First and only long acting C5 complement inhibitor to demonstrate clinical improvement in patients with generalised ...
Posted by Michael Wonder on 17 Jan 2023
Celltrion gets nod from Canadian regulator for sales of Avastin biosimilar
17 January 2023 - Celltrion obtained permission from Health Canada to sell Avastin (bevacizumab) biosimilar Vegzelma (CT-P16) on Tuesday. ...
Posted by Michael Wonder on 13 Jan 2023
Enhertu approved by Health Canada as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
12 January 2023 - Approval based on the DESTINY-Breast04 results which showed Enhertu reduced risk of disease progression or death ...
Posted by Michael Wonder on 10 Jan 2023
Qulipta now approved by Health Canada for the preventive treatment of episodic migraine in adults
9 January 2023 - Qulipta is the first and only oral calcitonin gene-related peptide receptor antagonist (gepant) specifically developed for the ...
Posted by Michael Wonder on 08 Jan 2023
JAMP Pharma Group receives Health Canada approval for JAMP Sitagliptin, a new generic alternative for the treatment of type 2 diabetes
6 January 2022 - The JAMP Pharma Group is pleased to announce the Health Canada approval of JAMP Sitagliptin, a generic ...
Posted by Michael Wonder on 04 Jan 2023
Samsung Bioepis announces Health Canada approval of citrate free high concentration of Humira biosimilar (adalimumab; SB5)
3 January 2023 - With the approval, Samsung Bioepis has both low (40 mg/0.8 mL) and high (40 mg/0.4 mL) concentration ...
Posted by Michael Wonder on 21 Dec 2022
Aequus announces Health Canada Notice of Compliance for Zimed Preservative Free (bimatoprost 0.03%)
20 December 2022 - Aequus Pharmaceuticals is pleased to announce that Health Canada has approved Zimed PF (bimatoprost 0.03%) for ...