Blog
RSS FeedPosted by Michael Wonder on 09 Jul 2018
Only immuno-oncology combination therapy approved by Health Canada as first-line treatment for advanced or metastatic renal cell carcinoma
9 July 2018 - Opdivo (nivolumab) and Yervoy (ipilimumab) combination is the first and only treatment to show significantly superior ...
Posted by Michael Wonder on 05 Jul 2018
Health Canada approves Erleada (apalutamide tablets), the first treatment for men with non-metastatic castration-resistant prostate cancer
4 July 2018 - Erleada decreased the risk of metastasis or death in patients by 70% and improved median metastasis-free survival ...
Posted by Michael Wonder on 29 Jun 2018
Health Canada approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to treat the underlying cause of cystic fibrosis in people ages 12 and older with certain mutations in the CFTR gene
28 June 2018 - Symdeko is Vertex’s third medicine to treat the underlying cause of cystic fibrosis. ...
Posted by Michael Wonder on 28 Jun 2018
Sunovion announces Health Canada approval of Aptiom (eslicarbazepine acetate) as monotherapy to treat partial-onset seizures in adults with epilepsy
27 June 2018 - Aptiom now provides a once-daily monotherapy treatment option for adults with partial-onset seizures. ...
Posted by Michael Wonder on 21 Jun 2018
Health Canada approves Taltz (ixekizumab) for treatment of active psoriatic arthritis
20 June 2018 - The approval of Taltz is based on the Phase 3 clinical trials that demonstrated efficacy on both ...
Posted by Michael Wonder on 20 Jun 2018
Health Canada approves Amgen's Repatha (evolocumab) to reduce the risk of cardiovascular events in adults with atherosclerotic cardiovascular disease
19 June 2018 - New indication supports Amgen's commitment to reduce the risk of recurrent cardiovascular events faced by heart attack ...
Posted by Michael Wonder on 14 Jun 2018
Alecensaro (alectinib) approved by Health Canada for first-line treatment of ALK-positive lung cancer
13 June 2018 - Targeted oral treatment shown to reduce risk of death or disease progression by more than half compared ...
Posted by Michael Wonder on 08 Jun 2018
Allergan's Restatis Multidose (cyclosporin 0.05% ophthalmic emulsion) approved in Canada
7 June 2018 - New delivery system will now provide Restasis in a preservative-free, easy-to-use, multi-dose bottle. ...
Posted by Michael Wonder on 04 Jun 2018
Apotex builds momentum in Canada's biosimilar market after world's first approval
1 June 2018 - Health Canada leads the way by approving the first-ever pegfilgrastim biosimilar in any highly regulated world ...
Posted by Michael Wonder on 17 May 2018
FDA faster than global peers at approving new drugs
16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the ...
Posted by Michael Wonder on 11 May 2018
Lynparza (olaparib) receives new indication for BRCA-mutated metastatic breast cancer
10 May 2018 - Lynparza has been shown to reduce the risk of disease progression or death by 42% compared ...
Posted by Michael Wonder on 10 May 2018
First and only immuno-oncology treatment, Imfinzi (durvalumab), for stage III, unresectable non-small-cell lung cancer now approved in Canada
9 May 2018 - Patients receiving Imfinzi in the PACIFIC clinical trial lived for nearly one year without their disease ...
Posted by Michael Wonder on 09 May 2018
Lynparza (olaparib) tablets receive approval as maintenance therapy treatment for ovarian cancer regardless of BRCA status
8 May 2018 - The treatment demonstrates a 65% reduction in disease progression or death. ...
Posted by Michael Wonder on 02 May 2018
Health Canada approves Kisqali for the treatment of HR-positive and HER2-negative metastatic breast cancer in post-menopausal women in combination with letrozole as an initial endocrine-based therapy
2 May 2018 - Arrival of new first-line therapy provides additional option for those living with this advanced form of breast ...
Posted by Michael Wonder on 21 Apr 2018
Sunovion announces Health Canada approval of Latuda (lurasidone hydrochloride) to treat adolescents (13 to 17 years of age) wth bipolar depression
20 April 2018 - Sunovion today announced that Health Canada has approved the supplemental new drug submission that expands the ...