The current big headache for Eli Lilly and Amylin is their diabetes drug Byetta, which the FDA has linked to six cases of fatal pancreatitis. The two companies, which jointly market the drug, held a conference call yesterday in which they hoped to calm nervous investors. (It...
SAN DIEGO and INDIANAPOLIS, Dec. 8 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that the U.S. Food and Drug Administration FDA is continuing with its review of the regulatory application for use of BYETTAR exenatide injection as stand-alone therapy monotherapy in people...
Samples and Professional Contact Favorably Impact Physicians Perceptions of Merck, According to a New Report from Decision Resources WALTHAM, Mass., Dec. 8 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that of surveyed patients who...
DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/research/a64686/competitor_analysi) has announced the addition of the "Competitor Analysis: GLP-1 Receptor Agonists" report to their offering. The Competitive Intelligence Report Glucagon-Like Peptide-1 (GLP-1) Analogs as of November 2008 provides a competitor analysis in the development pipeline of novel GLP-1 Analogs and GLP-1...
Changes will result in over $80 million reduction in 2009 cash expenditures SAN DIEGO, Nov. 10 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. today announced a corporate restructuring that will reduce its San Diego workforce by approximately 25 percent, or 340 employees, and reduce anticipated 2009 cash expenditures...
Diabetes is a tough disease to treat. Recently, to the relief of those of us who treat it, more and more effective medications have become available. But at the same time, increasing media scrutiny has led to unfair targeting of the same drugs that are helping us to control blood...
TWO DIABETES product sites, Merck's Januvia and Takeda's Actos, came in first and second, respectively, in a new study measuring physicians' web habits. The study, conducted by Manhattan Research, ranked drug product sites based on visitation rates from physicians. Merck had the most products on the list, at three,...
Billionaire activist investor Carl Icahn, known for shaking up the public firms he gains control of, raised his stake in Amylin Pharmaceuticals Inc. on Sept. 12. Icahn recently earned headlines as chairman of New York-based ImClone Systems Inc. for rejecting a $60-a-share offer by Bristol-Myers Squibb, then refusing to reveal...
The Food and Drug Administration warned physicians to immediately discontinue use of exenatide Byetta if pancreatitis is suspected, saying that it has received reports of six cases of necrotizing or hemorrhagic pancreatitis--including two deaths--since October 2007. At that time, a precaution about acute pancreatitis was added to exenatide's...
A new once-a-week formulation of the injectable diabetes drug Byetta controls blood sugar even better than the older twice-a-day formulation, researchers report. "Besides obvious improved ease of use, [the new formulation] provided the remarkable advantage of both improved efficacy on glucose control and good gastrointestinal tolerability," said Dr. Andre Scheen...
Patient Deaths Noted: In a conference call, executives with Amylin Pharmaceuticals Inc. acknowledged four more deaths reported to the FDA--but not previously made public--associated with the diabetes drug Byetta. The drug is co-marketed by San Diego-based Amylin and Eli Lilly and Co. of Indianapolis. The FDA...
Incretin agents Two agents are currently available in the United States that act upon the incretin hormone system--exenatide Byetta, a twice-daily glucagon-like peptide-1 (GLP-1) receptor agonist, and sitagliptin Januvia, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Additional agents are currently under review by the FDA or in phase 3 clinical...
This article reviews many of the key incretin clinical trials, with a focus on the efficacy and safety of glucagon-like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors compared with placebo and other glucose-lowering agents used as comparators. These agents have been tested either as monotherapy or in combination...
By Lynn Thomasson Bloomberg News The following companies are having unusual price changes in U.S. markets this morning. Airlines retreated after Citigroup Inc. said "significant risks remain" for U.S. carriers and oil jumped more than $2 a barrel, its third day...
The makers of the type 2 diabetes drug Byetta reported Tuesday the deaths of four more people who'd been taking the medication. The announcement by Eli Lilly and Amylin Pharmaceuticals Inc. came a week after the U.S. Food and Drug Administration said that two Byetta users had died of acute...
Worries about a potential link between the diabetes drug Byetta and six reported cases of a dangerous pancreas inflammation, which resulted in two deaths, sent shares of Amylin Pharmaceuticals Inc. down 13 percent Aug. 18. Shares of Amylin, traded under the symbol AMLN on Nasdaq, closed at $29.76....
Moore Labriola LLP and The Schmidt Firm, LLP represent Virginia man who developed pancreatitis FDA seeks more stringent warnings SAN DIEGO -- A Virginia man yesterday filed what is believed to be the first personal injury lawsuit stemming from injuries associated with the use of Byetta[R],...
According to national statistics, more than 20 million Americans--approximately 7% of the population--have type 2 diabetes. (1) With the number of new cases of type 2 diabetes rising each year in the United States, physicians have been challenged to find new approaches to managing the disease, particularly for patients who...
SAN FRANCISCO--An investigational once-weekly formulation of exenatide resulted in superior improvements in glucose control at 30 weeks, compared with the current twice-daily version, and clicited sustained glycemic control and weight loss at 1 year in patients with type 2 diabetes. The phase III data were presented in two...
