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RSS FeedPosted by Michael Wonder on 28 Oct 2020
Leo Pharma is withdrawing the drug Picato (ingenol mebutate), used to treat skin lesions, due to the potential increased risk of skin cancer
27 October 2020 - At Health Canada's request, Leo Pharma is withdrawing Picato from the Canadian market. ...
Posted by Michael Wonder on 28 Oct 2020
KYE Pharmaceuticals announces commercial availability of Firdapse in Canada
28 October 2020 - KYE Pharmaceuticals today announced an important milestone, Firdapse (amifampridine phosphate), the first amifampridine product approved in Canada, ...
Posted by Michael Wonder on 27 Oct 2020
Incyte announces Health Canada acceptance of the new drug submission for pemigatinib as a treatment for patients with cholangiocarcinoma
26 October 2020 - Incyte today announced that Health Canada has accepted its new drug submission for pemigatinib, a selective fibroblast ...
Posted by Michael Wonder on 24 Oct 2020
Medicago signs agreements with the Government of Canada to supply up to 76 million doses of its recombinant plant-derived COVID-19 vaccine
23 October 2020 - Canadian government to provide $173M in funding for vaccine research and development, and domestic manufacturing capacity. ...
Posted by Michael Wonder on 20 Oct 2020
Health Canada has approved Taltz (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis
19 October 2020 - Taltz is now approved to treat patients across the axSpA spectrum, including ankylosing spondylitis and non-radiographic axSpA. ...
Posted by Michael Wonder on 17 Oct 2020
Health Canada approves Keytruda (pembrolizumab) as first-line treatment for patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma
15 October 2020 - Approval Based on Significant Overall Survival Findings from Phase 3 KEYNOTE-048 Trial. ...
Posted by Michael Wonder on 15 Oct 2020
Health Canada approves first-ever gene replacement therapy, Luxturna
15 October 2020 - Luxturna (voretigene neparvovec), is the first approved therapy for previously untreatable inherited retinal disease. ...
Posted by Michael Wonder on 13 Oct 2020
Moderna announces initiation of rolling submission to Health Canada for mRNA vaccine against COVID-19 (mRNA-1273)
13 October 2020 - Confirmation underscores Moderna’s commitment to make its vaccine available in Canada. ...
Posted by Michael Wonder on 10 Oct 2020
Health Canada approves Inqovi (decitabine and cedazuridine) oral therapy for two types of blood cancers, MDS and CMML
8 October 2020 - Oral drug can be taken at home, which may enable some patients to avoid some hospital visits. ...
Posted by Michael Wonder on 10 Oct 2020
Pfizer Canada and BioNTech initiate rolling submission to Health Canada for SARS-CoV-2 vaccine candidate BNT162b2
9 October 2020 - Pfizer Canada and BioNTech will continue regular and open dialogue with Health Canada providing results from their ...
Posted by Michael Wonder on 08 Oct 2020
Health Canada approves Zeposia, an oral treatment for relapsing remitting multiple sclerosis
7 October 2020 - Bristol Myers Squibb's medication provides a new oral treatment option for Canadians living with the neurological disease. ...
Posted by Michael Wonder on 01 Oct 2020
Fibristal (ulipristal acetate 5 mg tablets) voluntary withdrawal in Canada due to risk of drug-induced liver injury
30 September 2020 - Allergan is working closely with Health Canada to voluntarily withdraw Fibristal (ulipristal acetate 5 mg tablets) ...
Posted by Michael Wonder on 30 Sep 2020
Health Canada approves Reblozyl (luspatercept), new class of treatment for adult patients living with beta thalassaemia
29 September 2020 - Reblozyl is the first and only erythroid maturation agent approved for use in Canada. ...
Posted by Michael Wonder on 22 Sep 2020
Sanofi and GSK sign agreements with the Government of Canada to supply up to 72 million doses of adjuvanted COVID-19 vaccine
22 September 2020 - Agreements relate to vaccine candidate using Sanofi’s recombinant protein-based technology and GSK’s pandemic adjuvant. ...
Posted by Michael Wonder on 22 Sep 2020
Health Canada approves Inrebic (fedratinib), first new treatment in nearly a decade for patients living with myelofibrosis
21 September 2020 - Inrebic provides new, once-daily oral option for patients affected by rare bone marrow cancer. ...