Novo Nordisk announced that it has received US FDA approval for Victoza® (liraglutide) for the treatment of type 2 diabete in adults.
Victoza® is the brand name approved in the US and Europe for liraglutide, the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. In the US, Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes....
Category: Injectable Medication
Novo Nordisk today announced that formal feedback from the United States Food and Drug Administration (FDA) regarding liraglutide is expected within weeks.
Liraglutide is the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes...
Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to Byetta (exenatide injection taken twice daily), in patients with type 2 diabetes...
The Swiss -based pharmaceuticals and diagnostics company Roche Holding AG announced headline results from the second and third of eight T-emerge Phase III studies for taspoglutide.
Taspoglutide is the first once-weekly human glucagon-like peptide-1 (GLP-1) analogue being developed to address the important unmet needs of patients with type 2 diabetes....
Novo Nordisk's CEO, Lars Sorensen, told Reuters at the Reuters Health Summit in New York that the new diabetes drug Victoza has reached the final decision stage at the U.S. FDA. Sorensen expects the drug will be approved, although "potentially all the outcomes are still possible...
Today the FDA indicated that the safety label of Byetta would be modified to include potential kidney problems including possible kidney failure. According to the FDA website "From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function in patients using Byetta." Seven million Byetta prescriptions were issued during this time, so this represents about 1 in 100,000 people being affected...
Amylin Pharmaceuticals, Inc. and Takeda Pharmaceuticals Company Limited announced an agreement to co-develop and commercialize pharmaceutical products for the treatment of obseity and related conditions. Amylin, whose top product, Byetta, had sales of $678.5 million last year. will receive a one-time up-front payment of $75 million from Takeda, the largest pharmaceutical
Isis pharmaceuticals announced positive mid-stage trial results for the drug called ISIS 113715. The drug, tested on Type 2 diabetics with poor glucose control, not only lowered blood glucose, but also caused reductions in LDL cholesterol and a tendency towards weight loss. Robert Henry, M.D., Professor of Medicine, University of California at San Diego and Chief, Section of Diabetes,