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. ...

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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. ...

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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 ...

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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. ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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, ...

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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 ...

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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 ...

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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 ...

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