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RSS FeedPosted by Michael Wonder on 13 May 2023
Tetra Bio-Pharma cancels new drug submission to Health Canada
11 May 2023 - Tetra Bio-Pharma today announced it has cancelled its new drug submission to Health Canada, without prejudice ...
Posted by Michael Wonder on 10 May 2023
Health Canada Approves AbbVie's Rinvoq (upadacitinib) for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis
9 May 2023 - Approval is based on results from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which Rinvoq ...
Posted by Michael Wonder on 09 May 2023
Rhythm Pharmaceuticals announces Health Canada approval of Imcivree setmelanotide injection for weight management in Bardet-Biedl syndrome or genetically-confirmed biallelic POMC, PCSK1, or LEPR deficiency
8 May 2023 - Approval granted following a priority review by Health Canada. ...
Posted by Michael Wonder on 05 May 2023
Dupixent (dupilumab injection) is now approved in Canada for the treatment of adult and adolescent patients (12+) with eosinophilic esophagitis
4 May 2023 - This is the eighth indication for Dupixent in Canada and its first in gastroenterology. ...
Posted by Michael Wonder on 04 May 2023
Health Canada approves Quviviq (daridorexant) for the management of adult patients with insomnia
3 May 2023 - Quviviq is indicated for the management of adult patients with insomnia, characterized by difficulties with sleep onset ...
Posted by Michael Wonder on 02 May 2023
Libtayo (cemiplimab) in combination with chemotherapy now approved in Canada for the first-line treatment of advanced non-small cell lung cancer
1 May 2023 - Approval marks second first-line indication in NSCLC and fifth indication for Libtayo in Canada. ...
Posted by Michael Wonder on 01 May 2023
Canada’s health minister denies interfering in agency’s efforts to lower drug costs
27 April 2023 - Health Minister Jean-Yves Duclos says he has not exercised any undue political pressure on the independent ...
Posted by Michael Wonder on 29 Apr 2023
Arcutis announces Canadian approval of Zoryve (roflumilast) cream 0.3% for treatment of plaque psoriasis in individuals 12 years and older
28 April 2023 - First Zoryve approval outside of the US marks key milestone for Arcutis. ...
Posted by Michael Wonder on 27 Apr 2023
CADTH, ICER, and NICE release joint position statement on redacting clinical data awaiting publication
24 April 2023 - The position statement is a step toward greater transparency of unpublished data and a tangible outcome ...
Posted by Michael Wonder on 27 Apr 2023
CADTH formalises offering on real-world evidence through its scientific advice program
25 April 2023 - During a 1-year learning period, CADTH expanded its Scientific Advice program to include advice on real-world evidence ...
Posted by Michael Wonder on 24 Apr 2023
Health Canada approves new antibody drug to help prevent serious RSV in babies
22 April 2023 - Health Canada has approved a new antibody drug to help protect babies from serious illness caused ...
Posted by Michael Wonder on 20 Apr 2023
Rybrevant (amivantamab) receives positive CADTH reimbursement recommendation for the treatment of adult patients with non-small cell lung cancer with activating EGFR exon 20 insertion mutations
6 April 2023 - This CADTH recommendation is a step towards public access to Rybrevant as a targeted therapy for ...
Posted by Michael Wonder on 18 Apr 2023
Health Canada approves Alhemo, the first subcutaneous prophylactic treatment for people living with haemophilia B with inhibitors
17 April 2023 - New treatment option for Canadians living with rare and serious X-chromosome linked congenital bleeding disorder ...
Posted by Michael Wonder on 15 Apr 2023
Pfizer Canada initiates submission to Health Canada for its bivalent respiratory syncytial virus vaccine
14 April 2023 - Indications under review include prevention of respiratory syncytial virus in infants from birth through 6 months ...
Posted by Michael Wonder on 13 Apr 2023
Vertex announces Health Canada market authorisation for Orkambi (lumacaftor/ivacaftor) in children with cystic fibrosis ages 1 to <2 years
10 April 2023 - With this approval, approximately 30 children with two copies of the F508del mutation are eligible for ...