KYE Pharmaceuticals and Catalyst Pharmaceuticals challenge Health Canada’s decision to overlook Firdapse data exclusivity

26 August 2020 - Catalyst Pharmaceuticals and KYE Pharmaceuticals today announced the filing of a proceeding in Canadian Federal Court ...

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Catalyst takes its fight over a rare disease drug to Canada, suing the country’s regulator

26 August 2020 - In unusual battle between two small companies over the market for a rare disease drug has ...

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Cystic fibrosis drug could reduce severe disease, deaths if made available to Canadians

25 August 2020 - Talia D’Alessio has been living with cystic fibrosis since she was nine months old. ...

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Knight and TherapeuticsMD announce Health Canada approval of Imvexxy

25 August 2020 - Knight Therapeutics and TherapeuticsMD announced today the approval of Imvexxy by Health Canada. In Canada, Imvexxy is ...

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Health Canada grants market authorization for Tecentriq in combination with bevacizumab, the first immunotherapy combination treatment, for the most common form of liver cancer

19 August 2020 - Tecentriq in combination with bevacizumab improved overall survival and progression-free survival compared to the previous standard of ...

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Dupixent (dupilumab injection) now approved by Health Canada for severe chronic rhinosinusitis with nasal polyposis

18 August 2020 - First biologic approved in Canada for adults with severe chronic rhinosinusitis with nasal polyposis. ...

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Piqray is approved and now available in Canada as the first and only treatment specifically for patients with a PIK3CA mutation in HR positive, HER2 negative advanced breast cancer

13 August 2020 - Approval is based on results from SOLAR-1, where Piqray in combination with fulvestrant nearly doubled median progression-free ...

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Elusys Therapeutics receives Health Canada approval for Anthim for the treatment of inhalation anthrax

12 August 2020 - Elusys Therapeutics today announced that Health Canada has approved the company's new drug submission for Anthim ...

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Health Canada approves Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy for the treatment of metastatic non-small cell lung cancer

11 August 2020 - CheckMate-9LA trial results demonstrated superior overall survival versus chemotherapy, regardless of PD-L1 expression or tumour histology. ...

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Catalyst Pharmaceuticals’ Firdapse (amifampridine phosphate) receives marketing approval in Canada for patients with LEMS

6 August 2020 - Catalyst Pharmaceuticals today announced that Canada’s national health care regulatory agency, Health Canada, has approved the ...

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Canada inks deals with Pfizer, Moderna for coronavirus vaccine candidates

5 August 2020 - The Canadian government has signed new deals with pharmaceutical firms Pfizer and Moderna to secure millions ...

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Janssen announces Health Canada approval of Darzalex SC, a new subcutaneous formulation for the treatment of patients with multiple myeloma

4 August 2020 - Darzalex SC reduces administration time from hours to minutes and demonstrates consistent efficacy with a reduction in ...

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Health Canada Approves Brivlera (brivaracetam) to treat partial-onset seizures in paediatric epilepsy patients

29 July 2020 - Health Canada's approval of Brivlera provides paediatric epilepsy patients with a treatment option which can be initiated ...

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Health Canada grants marketing authorisation with conditions for Gilead's Veklury (remdesivir) for the treatment of coronavirus disease 2019 (COVID-19)

28 July 2020 - Veklury is the first approved treatment option for COVID-19 in Canada. ...

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Spravato (esketamine) nasal spray is available for Canadian patients

22 July 2020 - A new anti-depressant with a novel mechanism of action to treat major depressive disorder in adults. ...

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