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RSS FeedPosted by Michael Wonder on 07 Feb 2021
Novavax announces start of rolling review by multiple regulatory authorities for COVID-19 vaccine authorisation
4 February 2021 - Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada. ...
Posted by Michael Wonder on 02 Feb 2021
Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima SC, for the treatment of people with rheumatoid arthritis
1 February 2021 - This novel formulation provides an alternative administration option for Canadian physicians and their patients. ...
Posted by Michael Wonder on 01 Feb 2021
Novavax submits vaccine for approval as Ottawa seeks EU reassurances on export rules
31 January 2021 - Canada's hopes of speeding up COVID-19 vaccinations brightened slightly over the weekend as regulators began work ...
Posted by Michael Wonder on 20 Jan 2021
Ontario doctors urge domestic drug manufacturing over fears of pandemic shortage
19 January 2021 - Chronic drug shortages have worsened during pandemic, Ontario Medical Association says. ...
Posted by Michael Wonder on 14 Jan 2021
Health Canada approves Imbruvica (ibrutinib) plus rituximab for the treatment of patients with chronic lymphocytic leukaemia
13 January 2021 - Patients aged 70 or younger with previously untreated CLL lived longer without disease progression compared to patients ...
Posted by Michael Wonder on 13 Jan 2021
Health Canada approves Onureg (azacitidine tablets), first maintenance therapy for patients in remission from acute myeloid leukaemia
12 January 2021 - Onureg has shown clinically meaningful increase in overall survival for patients. ...
Posted by Michael Wonder on 13 Jan 2021
MorphoSys and Incyte announce acceptance by Health Canada of the new drug submission for tafasitamab
12 January 2021 - MorphoSys and Incyte today announced that Health Canada has accepted the new drug submission for tafasitamab, an ...
Posted by Michael Wonder on 13 Jan 2021
Health Canada approves Lundbeck's Vyepti (eptinezumab)--the first and only intravenous preventive treatment for migraine
12 January 2021 - Lundbeck is pleased to announce that Vyepti (eptinezumab) has been approved by Health Canada for the preventive ...
Posted by Michael Wonder on 12 Jan 2021
Health Canada approves Bavencio for the maintenance treatment of patients with advanced bladder cancer
11 January 2021 - Bavencio is the first and only maintenance therapy for unresectable locally advanced or metastatic urothelial carcinoma ...
Posted by Michael Wonder on 06 Jan 2021
KYE Pharmaceuticals announces approval of Corzyna in Canada (ranolazine extended release tablets)
5 January 2020 - KYE Pharmaceuticals today announced an important milestone, Corzyna (ranolazine extended release tablets) has now been approved by ...
Posted by Michael Wonder on 31 Dec 2020
Tetra Bio-Pharma files new drug submission for Reduvo in Canada
30 December 2020 - The addressable market is estimated to be $80 million CDN by 2022. ...
Posted by Michael Wonder on 29 Dec 2020
Vertex announces new drug submission for investigational triple combination medicine for the treatment of cystic fibrosis has been accepted for priority review by Health Canada
28 December 2020 - Vertex Pharmaceuticals Incorporated today announced its New Drug Submission for Trikafta, Vertex’s investigational triple combination medicine, ...
Posted by Michael Wonder on 27 Dec 2020
Dr. Reddy's Laboratories, Global Response Aid, and Appili Therapeutics announce the filing of an application for Reeqonus (favipiravir) tablets for the treatment of COVID-19 under Health Canada’s Interim Order
22 December 2020 - Dr. Reddy’s Laboratories, Appili Therapeutics and Global Response Aid today announced that Dr. Reddy’s Canada has ...
Posted by Michael Wonder on 26 Dec 2020
Canada approves the Moderna vaccine, paving the way for inoculations in its vast far north
23 December 2020 - Canada’s regulator approved Moderna’s vaccine on Wednesday, a move that will make it easier to inoculate ...
Posted by Michael Wonder on 23 Dec 2020
Health Canada approves ALK's Ragwitek sublingual allergy immunotherapy tablets for paediatric patients with ragweed allergy
22 December 2020 - With the indication expanded to paediatric patients, ALK Canada now provides adults and children a SLIT tablet ...