MAA submitted to the European Medicines Agency for dasiglucagon for treatment of severe hypoglycemia in diabetes – Novo Nordisk + Zealand Pharma

Zealand Pharma A/S a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for dasiglucagon injection for the treatment of severe hypoglycemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus. Dasiglucagon injection was approved by the FDA […]

CHMP extends the indication of Refixia to prophylaxis of bleeding in patients 12 years and above with haemophilia B – Novo Nordisk

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Wegovy demonstrated significant and sustained weight loss in two-year study in adults with obesity – Novo Nordisk

Results from the STEP 5 phase IIIb trial, presented by Novo Nordisk at the Obesity Week 2021 interactive congress, showed that adults treated with Wegovy (semaglutide 2.4 mg injection) achieved significant and sustained weight loss over the two-year study period . The STEP 5 trial investigated Wegovy vs. placebo, both used with a reduced calorie meal plan and increased physical […]

Investigational 2.0 mg dose of once weekly Ozempic demonstrates superior reductions in blood sugar vs Ozempic 1.0 mg in type II diabetes – Novo Nordisk

Novo Nordisk presented data showing that an investigational 2.0 mg dose of Ozempic (semaglutide) provided statistically significant and superior reductions in blood sugar (HbA1C) compared with Ozempic 1.0 mg. These data were the outcome of the SUSTAIN FORTE trial, a phase IIIb, 40-week, efficacy and safety trial comparing once-weekly semaglutide 2.0 mg vs Ozempic 1.0 mg as add-on to metformin […]

CHMP recommends expanded approval for Saxenda in obesity – Novo Nordisk

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