Tags : Health Canada

Regulatory

Janssen’s Darzalex (daratumumab, SC) Combination Regimen Receives Health Canada’s Approval

Shots: The approval is based on results from the P-III ANDROMEDA (AMY3001) study involves assessing the safety and efficacy of Darzalex (1800mg, SC, qw) + bortezomib, cyclophosphamide, and dexamethasone (VCd) vs VCd alone in 388 patients with newly diagnosed AL amyloidosis The study showed higher hematologic response rate in ITT population (53% vs 18%), patients […]Read More

COVID-19 Regulatory

Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

Shots: Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use Following an agreement to supply 20M of doses for the Government of Canada, AstraZeneca seek out Health Canada’s clearance in Oct’2020, leading to data submission done on a rolling basis for accelerating the review […]Read More