Blog
RSS FeedPosted by Michael Wonder on 04 Feb 2022
Samsung Bioepis announces Health Canada approval of 150 mg single-use vial and 440 mg multi-dose vial of Ontruzant (SB3), trastuzumab biosimilar for the treatment of adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer
2 February 2022 - 150 mg and 440 mg vial of Ontruzant are now approved in Canada. ...
Posted by Michael Wonder on 01 Feb 2022
Celltrion Healthcare announces Canadian approval of Yuflyma, a high concentration, low volume, citrate free and latex free Humira (adalimumab) biosimilar
31 January 2022 - Yuflyma brings a new offering to healthcare practitioners and their patients with inflammatory diseases in Canada. ...
Posted by Michael Wonder on 31 Jan 2022
Health Canada authorises Verzenio (abemaciclib) as the first and only CDK4/6 inhibitor for patients with HR+ HER2- high risk early breast cancer
27 January 2022 - Adding Verzenio to endocrine therapy demonstrated a significant and clinically meaningful reduction in the risk of recurrence ...
Posted by Michael Wonder on 24 Jan 2022
Health Canada approves Ipsen’s Sohonos (palovarotene) as the first approved treatment for fibrodysplasia ossificans progressiva
24 January 2022 - Ipsen today announced the Health Canada approval of Sohonos (palovarotene), an oral selective retinoic-acid receptor gamma agonist ...
Posted by Michael Wonder on 18 Jan 2022
Canada approves Pfizer COVID drug
18 January 2022 - Canada’s health regulator has approved a pill by Pfizer that treats the effects of COVID-19. ...
Posted by Michael Wonder on 13 Jan 2022
JAMP and Alvotech announce Canadian approval of Simlandi, a high concentration biosimilar to Humira, providing access to previously unavailable versions in Canada
10 January 2021 - Health Canada rules that 40 mg/0.4 mL and 80 mg/0.8 mL presentations of Simlandi are not subject ...
Posted by Michael Wonder on 31 Dec 2021
Celltrion acquires approval for its new Humira 'Yuflyma' in Canada
30 December 2021 - Celltrion announced on December 30 that it won marketing approval from Health Canada for "Yuflyma", a ...
Posted by Michael Wonder on 26 Dec 2021
SIGA announces Health Canada regulatory approval of oral TPOXX
1 December 2021 - SIGA Technologies today announced that Health Canada has approved oral Tpoxx (tecovirimat) as an extraordinary use new ...
Posted by Michael Wonder on 26 Dec 2021
GSK’s Jemperli (dostarlimab for injection) approved in Canada as an anti-PD-1 therapy for recurrent or advanced endometrial cancer
15 December 2021 - GSK announces today that it has been granted Notice of Compliance with conditions for its endometrial ...
Posted by Michael Wonder on 10 Dec 2021
VBI Vaccines announces filing of new drug submission for 3 antigen hepatitis B vaccine to Health Canada
9 December 2021 - VBI Vaccines today announced the filing of a new drug submission to Health Canada for the Company’s ...
Posted by Michael Wonder on 09 Dec 2021
Canada's national strategy for drugs for rare diseases needs a holistic approach
8 December 2021 - International report summarises drugs for rare disease best practices and recommendations. ...
Posted by Michael Wonder on 02 Dec 2021
Pfizer Canada initiates submission to Health Canada for COVID-19 oral anti-viral candidate
1 December 2021 - Pfizer Canada today initiated the filing of a rolling new drug submission with Health Canada for its ...
Posted by Michael Wonder on 27 Nov 2021
Shingrix approved in Canada for adults at increased risk of shingles due to immunodeficiency or immunosuppression
25 November 2021 - GlaxoSmithKline today announced that Shingrix (Zoster Vaccine Recombinant, Adjuvanted) has been approved in Canada for the prevention ...
Posted by Michael Wonder on 26 Nov 2021
Johnson & Johnson COVID-19 vaccine fully approved by Health Canada to prevent COVID-19 in individuals 18 years and older
24 November 2021 - Vaccine demonstrates protection against COVID-19 related hospitalisation and death, and across different variants. ...
Posted by Michael Wonder on 26 Nov 2021
Health Canada issues Notice of Compliance for Trodelvy, a new treatment option for an aggressive type of metastatic breast cancer
25 November 2021 - Trodelvy significantly reduced the risk of death by 49% compared with single agent chemotherapy in the ...