Canada

Samsung Bioepis Expand its Footprints with the Launch of Hadlima (biosimilar, adalimumab) in Australia and Canada

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Shots: Samsung Bioepis in collaboration with Merck broadens its global reach by launching Hadlima in Australia for multiple autoimmune diseases With the launch in Australia, Samsung Bioepis’ adalimumab is now available in three markets: Europe, Canada, and Australia Hadlima is Samsung Bioepis’ third anti-TNF biosimilar… Read More »Samsung Bioepis Expand its Footprints with the Launch of Hadlima (biosimilar, adalimumab) in Australia and Canada

Fresenius Kabi Launches Idacio (biosimilar, adalimumab) for Multiple Chronic Inflammatory Conditions in Canada

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Shots: Health Canada has authorized Idacio on Oct 30, 2020, for marketing in Canada and is now available for all indications of the reference (Humira) in the field of rheumatology, gastroenterology and dermatology Health Canada’s approval was based on analytical, pre/ clinical data that demonstrated… Read More »Fresenius Kabi Launches Idacio (biosimilar, adalimumab) for Multiple Chronic Inflammatory Conditions in Canada

Celltrion Receives Health Canada’s Approval for Remsima SC (biosimilar, infliximab) for Rheumatoid Arthritis

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Shots: The Health Canada has granted a NOC which is based on clinical evidence for Remsima/CT-P13 SC vs CT-P13 IV up to 1year in patients with RA. The results demonstrated that switching patients from Remsima IV to its SC formulation @30wks. is comparable to maintaining… Read More »Celltrion Receives Health Canada’s Approval for Remsima SC (biosimilar, infliximab) for Rheumatoid Arthritis

Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

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Shots: Abbott’s next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received Health Canada’s approval for adults & children with diabetes The system continuously measures glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high/low without scanning The technology… Read More »Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

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Shots: The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second Ab vs PBO for the treatment of symptomatic COVID-19 in the outpatient setting Results: reduction in viral load & rates… Read More »Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

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Shots: Health Canada has approved Luxturna (voretigene neparvovec) as a one-time gene therapy for the treatment of adult & pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells Luxturna is designed… Read More »Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease