Blog
RSS FeedPosted by Michael Wonder on 27 Jun 2021
In an about face, Health Canada allows a controversial rare disease drug back on the market
26 June 2021 - In yet another twist in a complicated tale, Health Canada has reinstated approval of a rare ...
Posted by Michael Wonder on 21 Jun 2021
Notice of Compliance with Conditions granted for Retevmo (selpercatinib), the first therapy in Canada specifically for patients with advanced RET driven lung and thyroid cancers
21 June 2021 - Conditional marketing authorisation based on data from LIBRETTO-001 Phase 1/2, the largest trial ever reported in patients ...
Posted by Michael Wonder on 21 Jun 2021
Cystic fibrosis life-altering drug nearing patient access across the country: Health Canada
20 June 2021 - For the cystic fibrosis community, persistence and constant belief are paying off. ...
Posted by Michael Wonder on 18 Jun 2021
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in people ages 12 and older who have at least one F508del mutation
18 June 2021 - Approximately 1,100 F/MF patients now eligible for a CFTR modulator to treat the underlying cause of their ...
Posted by Michael Wonder on 17 Jun 2021
Dupixent (dupilumab) pre-filled pen now available in Canada, providing convenient self-administration option for people with type 2 inflammatory diseases
17 June 2021 - The pre-filled pen offers an additional administration option for all Dupixent indications in patients aged 12 years ...
Posted by Michael Wonder on 15 Jun 2021
Amylyx Pharmaceuticals files new drug submission for AMX0035 for the treatment of ALS in Canada
14 June 2021 - Submission supported by data from the CENTAUR trial. ...
Posted by Michael Wonder on 11 Jun 2021
Controversial Alzheimer’s drug approved in U.S. Where does Canada stand?
10 June 2021 - The Alzheimer Society of Canada welcomed the new treatment urging Canadian health authorities to complete its required ...
Posted by Michael Wonder on 10 Jun 2021
Health Canada grants interim order authorisation for casirivimab and imdevimab for the treatment of mild to moderate COVID-19
10 June 2021 - Interim data shows treatment with casirivimab and imdevimab resulted in a statistically significant reduction in viral ...
Posted by Michael Wonder on 09 Jun 2021
Paladin Labs announces approval of Wakix (pitolisant) in Canada
9 June 2021 - Paladin Labs today announced Health Canada's approval of Wakix (pitolisant) for the treatment of excessive daytime sleepiness ...
Posted by Michael Wonder on 08 Jun 2021
Moderna files for authorisation with Health Canada for its COVID-19 vaccine in adolescents
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 08 Jun 2021
Health Canada approves AbbVie's Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis
7 June 2021 - Approval supported by efficacy and safety data of two pivotal Phase 3 trials in which Rinvoq demonstrated ...
Posted by Michael Wonder on 07 Jun 2021
After repeated losses in the U.S., Catalyst wins a victory in Canada over a rare disease drug
3 June 2021 - In an unexpected move, Canada’s Federal Court quashed the approval of a rare disease drug after ...
Posted by Michael Wonder on 03 Jun 2021
Health Canada accepts new drug submission for Reduvo as a treatment for patients with chemotherapy-induced nausea and vomiting
2 June 2021 - Tetra Bio-Pharma announced today that Health Canada has accepted its new drug submission for Reduvo and has ...
Posted by Michael Wonder on 02 Jun 2021
Health Canada approves Opdivo (nivolumab) plus Yervoy (ipilimumab) as the first and only immunotherapy treatment for previously untreated unresectable malignant pleural mesothelioma
2 June 2021 - First new systemic therapy in more than 15 years for cancer related to asbestos exposure. ...
Posted by Michael Wonder on 01 Jun 2021
Health Canada approves Abecma (idecabtagene vicleucel), the first and only anti-BCMA CAR T cell therapy for relapsed and refractory multiple myeloma
31 May 2021 - Abecma is the first personalised cell therapy available to Canadian patients for the treatment of adults ...