Guidance for reporting real world evidence

31 May 2023 - CADTH has partnered with Health Canada, the Institut national d’excellence en santé et en services sociaux (INESSS), ...

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Brukinsa approved in Canada for the treatment of chronic lymphocytic leukaemia

30 May 2023 - BeiGene’s Bruton's tyrosine kinase inhibitor is approved in more than 65 markets globally. ...

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Valneva files for Chikungunya vaccine authorisation with Health Canada

30 May 2023 - Valneva today announces the filing of a regulatory application with Health Canada for marketing approval of ...

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Roche Canada and the pan-Canadian Pharmaceutical Alliance successfully complete negotiations for Vabysmo (faricimab injection) for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular oedema

29 May 2023 - Roche Canada today announced that it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance for ...

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FORUS Therapeutics and the Pan-Canadian Pharmaceutical Alliance complete negotiations for Xpovio (selinexor)

24 May 2023 - The pCPA agreement will support the public listings and reimbursement of Xpovio. ...

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Health Canada’s position on the CADTH guidance for reporting RWE to support decision-making

18 May 2023 - Canada’s CADTH collaborated with Health Canada and other stakeholders to develop the guidance for reporting real world ...

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Collaboration creates roadmap in Canada to report real world evidence studies

16 May 2023 - CADTH, Health Canada, and the Institut national d’excellence en santé et en services sociaux (INESSS) are ...

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Health Canada accepts new drug submission for lecanemab as treatment for early Alzheimer’s disease

15 May 2023 - Eisai and Biogen announced today that Health Canada has accepted a new drug submission for lecanemab for ...

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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 ...

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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 ...

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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. ...

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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. ...

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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 ...

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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. ...

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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 ...

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