Drug Development Pharma - April 22, 2015
More Good News for Kidney Transplant Drug
Trials of once-daily Envarsus® XR, an investigational drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower dose in African-American patients is sufficient for therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus, according to Veloxis. Veloxis is seeking an order requiring the FDA to […]
Drug Development Pharma - April 9, 2015
FDA Accepts Novo Resubmission
The US Food and Drug Administration (FDA) has accepted for review Novo Nordisk’s Class II Resubmissions for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data, according to the company. This team has prepared the interim analysis […]
Drug Development Pharma - March 24, 2015
EC Approves Weight-Loss Drug
The European Commission has granted marketing authorization for Novo Nordisk’s Saxenda® (liraglutide 3 mg) for the treatment of obesity. The authorization covers all 28 European Union (EU) member states. Saxenda® is the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity approved in Europe. Saxenda® is prescribed as a supplement to a reduced-calorie diet and increased physical […]
Drug Development Pharma - March 10, 2015
Health Canada OKs Weight Drug
Health Canada has approved the new drug submission for Novo Nordisk’s Saxenda® (liraglutide), the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of chronic weight management. Saxenda® is an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in obese adults and overweight adults with at least one […]
Drug Development Pharma - March 10, 2015
CHMP Clears Drug Label Update
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for a label update of H. Lundbeck A/S’s Brintellix® for its effect on certain aspects of cognitive function in patients with depression. This will be the first summary of the product characteristics of an antidepressant to […]
Drug Development Pharma - March 4, 2015
Progress on Drug for Orphan Disease
Orphazyme, a Danish biotech company working on the development of orphan drugs, recently completed a new series B capital round of 20 million Euro. Kurma Partners and Idinvest Partners joined the existing investor syndicate of Novo A/S, Sunstone Capital and Aescap Venture. The company is working on Arimoclomol, the leading drug candidate for the treatment […]
