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The U.S. Food and Drug Administration has withheld approval of Bydureon, the once-weekly version of the popular type 2 diabetes drug Byetta. The agency has asked its manufacturer, Amylin, for more information regarding Bydureon's manufacture, labeling, and risk management plan. It did not, however, request further information on tests of the drug itself-an indication that the agency probably intends to grant marketing permission once it has dotted all the i's and crossed all the t's involved in the approval process.
0 comments - Mar 29, 2010 -
The sooner people with diabetes start taking metformin, the longer the drug remains effective, according to a Kaiser Permanente study published in the March issue of Diabetes Care, a journal of the American Diabetes Association.
2 comments - Mar 12, 2010 -
Amylin Pharmaceuticals has announced that it expects to begin selling a once-weekly version of its diabetes drug, Byetta, by the end of the year. The company reports that the FDA is nearing final inspections of its manufacturing plant and could give the go-ahead for U.S. sales in early March.
2 comments - Mar 4, 2010 -
Danish pharmaceutical company Novo Nordisk has received Food and Drug Administration permission to begin marketing its type 2 drug Victoza® in the United States.
Victoza, the brand name for liraglutide, is a GLP-1* analog that is taken one a day by injection to help control blood sugar-and in some cases, help with weight loss-in patients with type 2 diabetes.
5 comments - Feb 27, 2010 -
A study commissioned by healthcare company Novo Nordisk has reported that the cost of diabetes and pre-diabetes to the U.S. economy in 2007 was $218 billion. The study, conducted by The Lewin Group, projected that by 2034, the two conditions will cost the economy $336 billion per year.
1 comment - Feb 3, 2010 -
Denmark-based Novo Nordisk has begun a Phase 1 trial of a pill form of a GLP-1 drug very similar to its Victoza product. The trial will involve 155 British patients with type 2 diabetes. The test on human subjects, although very early-stage, puts the company in the lead to develop an oral form of a GLP-1 drug.
0 comments - Feb 1, 2010 -
Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza (liraglutide injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
4 comments - Jan 28, 2010 -
Denmark-based Novo Nordisk A/S has begun phase 1 testing of an insulin pill that, if successful, could replace injections as the primary means of blood sugar control for millions of people with type 1 and type 2 diabetes. The company has enrolled 80 volunteer German test subjects in the study and expects to have preliminary results by the first half of 2011. The test group consists of both people with diabetes and people without it.
12 comments - Dec 24, 2009 -
PRINCETON, NJ (November 27, 2009) - The diabetes population in the United States will almost double over the next 25 years and annual medical spending on the disease is projected to hit $336 billion, up from $113 billion today, according to a study published in the December issue of Diabetes Care. The National Changing Diabetes® Program (NCDP), a program of Novo Nordisk, commissioned the analysis by a team from the University of Chicago.
5 comments - Nov 27, 2009 -
PRINCETON, N.J., Nov. 19 /PRNewswire/ -- Nearly one-third of doctors surveyed said they did not have enough time and did not receive sufficient reimbursement to provide comprehensive care to their patients with diabetes, according to the results of a study of endocrinologists and primary care doctors published in American Health & Drug Benefits.
4 comments - Nov 20, 2009 -
Diabetes Health is the essential resource for people living with diabetes- both newly diagnosed and experienced as well as the professionals who care for them. We provide balanced expert news and information on living healthfully with diabetes. Each issue includes cutting-edge editorial coverage of new products, research, treatment options, and meaningful lifestyle issues.