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After several years of delays and setbacks, Amylin Pharmaceuticals has received FDA approval to begin US marketing of BydureonTM. The first once-a-week type 2 therapy to be offered in the US market, Bydureon is expected to be available by February. Amylin says that its wholesale price will be about $4,200 a year.
2 comments - Feb 3, 2012 -
French drug maker Sanofi-aventis says that results from a Phase III trial of its experimental type 2 diabetes drug lixisenatide show that the drug successfully lowered patients' blood glucose levels and body weight, but did not increase the risk of hypoglycemia.
0 comments - May 23, 2011 -
A study released in late June has brought some welcome news to the makers of Byetta and Januvia: Users of the two diabetes drugs run no greater risk of developing pancreatitis than people with diabetes who take other drugs. In fact, both drugs seem to put users at slightly less risk for the condition.
0 comments - Jul 8, 2010 -
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 -
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 -
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 7, 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.
6 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.
1 comment - 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.
1 comment - May 12, 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.
2 comments - May 6, 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.