Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 19 Dec 2022
Draft guidance document on the collection and analysis of disaggregated data in clinical trials: transparency
16 December 2022 - This guidance will help sponsors interpret amendments to the Food and Drug Regulations (regulations) requiring them ...
Posted by Michael Wonder on 10 Dec 2022
Health Canada authorises the Pfizer-BioNTech Omicron BA.4/BA.5 bivalent adapted COVID-19 booster for children 5 to 11 years of age
9 December 2022 - Today, Health Canada authorised the Pfizer-BioNTech Comirnaty Omicron BA.4/BA.5 bivalent adapted booster for use in children 5 ...
Posted by Michael Wonder on 10 Dec 2022
VBI Vaccines announces Health Canada approval for PreHevbrio for the prevention of hepatitis B in adults
8 December 2022 - VBI Vaccines today announced that Health Canada has approved PreHevbrio [3 antigen hepatitis B vaccine (recombinant)] for ...
Posted by Michael Wonder on 10 Dec 2022
Sobi receives approval from Health Canada for Empaveli (pegcetacoplan) for the treatment of certain patients with paroxysmal nocturnal haemoglobinuria
9 December 2022 - Approval based on results from head to head PEGASUS Phase 3 trial where Empaveli demonstrated superiority to ...
Posted by Michael Wonder on 07 Dec 2022
Novavax Nuvaxovid COVID-19 vaccine approved in Canada for use as a primary series in adolescents
7 December 2022 - Novavax today announced that Health Canada has approved a supplement to a new drug submission for Nuvaxovid ...
Posted by Michael Wonder on 29 Nov 2022
Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU
29 November 2022 - Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...
Posted by Michael Wonder on 29 Nov 2022
Health Canada has approved Sotyku (deucravacitinib tablets), an oral treatment for adults with moderate to severe plaque psoriasis
28 November 2022 - Sotyktu is the first and only approved TYK2 inhibitor in Canada and represents an important milestone ...
Posted by Michael Wonder on 26 Nov 2022
GSK Canada submits respiratory syncytial virus vaccine candidate for regulatory review
25 November 2022 - Application includes important pivotal Phase 3 data evaluating the efficacy and safety of our vaccine candidate against ...