Blog
RSS FeedPosted 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 26 Apr 2018
Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada
26 April 2018 - The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into ...
Posted by Michael Wonder on 26 Apr 2018
Proposals for prescription drug transparency
25 April 2018 - This report presents a summary of responses to the Therapeutic Products Directorate's consultation on proposals for ...
Posted by Michael Wonder on 21 Apr 2018
Knight Therapeutics announces Canadian regulatory approval for Probuphine for opioid drug dependence
20 April 2018 - Knight Therapeutics announced today that Health Canada has approved Probuphine (buprenorphine subdermal implant) for the management of ...
Posted by Michael Wonder on 21 Apr 2018
Indivior announces new drug submission to Health Canada for Sublocade (buprenorphine extended-release) injection for the treatment of moderate to severe opioid use disorder
20 April 2018 - Health Canada grants priority review designation for Sublocade. ...
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 ...
Posted by Michael Wonder on 19 Apr 2018
Xultophy approved in Canada for the treatment of adults with type 2 diabetes
18 April 2018 - Once-daily Xultophy has been shown to help patients achieve blood glucose targets. ...
Posted by Michael Wonder on 18 Apr 2018
Sobi receives approval from Health Canada for once-daily dosing of Orfadin (nitisinone) for the treatment of HT-1
17 April 2018 - First and only nitisinone product in Canada approved for once-daily use, designed to meet the needs of ...
Posted by Michael Wonder on 12 Apr 2018
Health Canada accepts Mitsubishi Tanabe Pharma Corporation's NDS filing for edaravone to treat ALS, grants priority review
9 April 2018 - Mitsubishi Tanabe Pharma Canada launched in Toronto to prepare business operations. ...
Posted by Michael Wonder on 11 Apr 2018
Penthrox receives marketing authorisation from Health Canada for adult patients requiring relief from moderate to severe acute pain associated with trauma or interventional medical procedures
10 April 2018 - Purdue Pharma (Canada) and Medical Developments International Limited, announce today that Penthrox, a low dose methoxyflurane, has ...
Posted by Michael Wonder on 09 Apr 2018
Health Canada approves Tecentriq (atezolizumab) for the treatment of patients with metastatic non-small-cell lung cancer
9 April 2018 - Tecentriq provides a new cancer immunotherapy option for Canadians living with the difficult disease. ...
Posted by Michael Wonder on 07 Apr 2018
Besponsa approved by Health Canada for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
6 April 2018 - First and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory CD22-positive ...
Posted by Michael Wonder on 06 Apr 2018
Trelegy Ellipta approved in Canada as the first single inhaler triple therapy for the treatment of appropriate patients with COPD
5 April 2018 - Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), has been approved in Canada as the first and only inhaler product ...