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Most clinical studies of new drugs are conducted primarily on white men, whether or not they are most affected by the disease the drug is intended to treat. African Americans, for example, are 1.6 times more likely to have diabetes than non-Hispanic whites. Why should we assume that what works for white males will also be effective for African Americans, Hispanics, Asians, or, for that matter, women?
0 comments - Aug 6, 2009 -
High percentages of endocrinologists, primary care physicians, and managed care organizations surveyed by a research firm say they would like to see additional GLP-1 analogues like Amylin/Eli Lilly's Byetta® and DPP-IV inhibitors like Merck's Januvia® available to treat type 2 diabetes.
0 comments - Jul 25, 2009 -
In 2008, the U.S. Food and Drug Administration published strong warnings that the type 2 diabetes drug exenatide (trade name Byetta) might increase risk of acute pancreatitis, a painful inflammation of the pancreas. The FDA's action came in the wake of reports that 30 exenatide users had come down with pancreatitis and that six of them had died from the condition.
0 comments - Jun 19, 2009 -
It has been an interesting month for San Diego-based Amylin Pharmaceuticals Inc., the co-manufacturer of Byetta (exenatide) with Eli Lilly & Co., and Alkermes Inc. First, the company announced that it will reduce its sales force by 35 percent-200 employees-in hope of saving $20 million this year and $45 million annually starting in 2010. The company plans to retain 325 representatives to sell its diabetes products to doctors and endocrinologists. At the same time, Amylin has petitioned the FDA to approve the marketing of Byetta LAR, a form of the type 2 drug that requires injection only once a week.
0 comments - May 11, 2009 -
The European Union's drug regulation agency has recommended that the EU approve the marketing of "Victoza" (liraglutide), a type 2 drug developed by Novo Nordisk.
0 comments - May 6, 2009 -
Results from DURATION-2, a 26-week test comparing the diabetic drugs Januvia, Actos, and experimental long-acting Byetta (Byetta LAR) show that Byetta produced lower A1c's and more weight loss than the other two drugs.
0 comments - Apr 15, 2009 -
Buoyed by its recent successful phase 1 human clinical trial of a patch that delivers basal insulin through the skin, Atlanta-based Altea Therapeutics says it will work with Eli Lilly and Company and Amylin Pharmaceuticals, Inc., to develop a daily transdermal patch that deliver sustained levels of Byetta (exenatide). The patch, in a 12- and a 24-hour form, will use the company's proprietary PassPort Transdermal Delivery System. Lilly and Amylin will fund all development, manufacturing, and marketing activities for the product.
0 comments - Apr 7, 2009 -
The FDA has announced that starting in early April, its Endocrinologic and Metabolic Drugs Advisory Committee will begin looking into two new drugs for type 2 diabetes: saxagliptin tablets from Bristol-Meyers Squibb and liraglutide, an injection drug from Novo Nordisk.
0 comments - Mar 24, 2009 -
Hopes that the U.S. Food and Drug Administration would move soon to make the diabetes drug Byetta a monotherapy are fading. It now appears that the FDA will extend its review of the drug into 2009.
0 comments - Dec 15, 2008 -
A recent Wall Street Journal article shows once again how misinformation about diabetes-related topics can be spread by even the most expert journalists.
0 comments - Oct 27, 2008 -
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.