Tags : receives

Regulatory

Alexion’s Ultomiris (ravulizumab) Receives CHMP’s Positive Opinion Recommending its Approval

Shots: The CHMP’s positive opinion is based on a P-III study assessing Ultomiris and showed effectiveness in completing C5 complement inhibition @26wks. for children & adolescents aged ≤18yrs. with PNH The study demonstrated that there is no reported treatment-related sAEs, and no patients discontinued treatment during the primary evaluation period or experienced breakthrough hemolysis The […]Read More

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