Drug Development Pharma - June 9, 2015
Janssen Submits BLA to FDA
Genmab A/S’s licensing partner Janssen Biotech, Inc. has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for daratumumab for double refractory multiple myeloma. The submission is for using daratumumab to treat patients with multiple myeloma who have received at least three different lines of therapy […]
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 […]
