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Diabetes and Byetta

Page 2
Amylin Cuts Workforce, Asks FDA to Approve Once-Weekly Byetta

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.

Comments 1 comment - May 11, 2009 - * * * * *

Type 2 Drugs: EU Approves “Victoza,” FDA Extends Review of “Onglyza”

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.

Comments 2 comments - May 6, 2009 - * * * * *

Long-Acting Byetta Tops Two Other Diabetes Drugs in Direct Comparison

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.

Comments 5 comments - Apr 15, 2009 - * * * * *

Altea Partners With Amylin and Lilly to Develop 12-Hour Byetta Skin Patch

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. 

Comments 2 comments - Apr 7, 2009 - * * * * *

FDA Poised to Review Two New Drugs for Type 2 Diabetes

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.

Comments 1 comment - Mar 24, 2009 - * * * * *

FDA Unlikely to Approve Byetta Monotherapy Soon
FDA Unlikely to Approve Byetta Monotherapy Soon

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.

Comments 5 comments - Dec 15, 2008 - * * *

How Diabetes Topics in the News Can Start to Feel Like a Game of “Telephone”

A recent Wall Street Journal article shows once again how misinformation about diabetes-related topics can be spread by even the most expert journalists.

Comments 3 comments - Oct 27, 2008 - * * * *

Amylin’s Woes Mount, Thanks to FDA Actions

The stock of Byetta manufacturer Amylin Pharmaceuticals has lost more than half of its value over the past eight weeks, thanks to FDA concerns that the type 2 treatment may be connected with the deaths from acute pancreatitis of six Byetta users. Although the FDA has not proven a direct association between fatal pancreatitis and the use of Byetta, Amylin's stock has fallen nevertheless.

Comments 0 comments - Oct 13, 2008 - * * *

Good News for Byetta (Exenatide): Canadian Study Reports Once-Weekly Dose Is Better at BG Control Than Twice Daily

A Canadian clinical study has delivered a double dose of good news for proponents of exenatide (sold commercially as Byetta), a drug used by more than 700,000 Americans to control blood glucose, ease food cravings, and, incidentally, lose weight.  

Comments 3 comments - Sep 11, 2008 - * * * * *

Byetta Takes a Beating as Feds Question Its Safety; Defender Chides FDA for Bureaucracy and Bad Science

Byetta has had a tough past few days. A lawsuit by a Virginia man alleges that the drug caused his life-threatening bout of severe pancreatitis, and there are rumblings from the U.S. Food and Drug Administration that it may force Byetta's makers to attach a "black box" warning to its container and packaging-a stern, highlighted caution about potentially dangerous, even fatal, side effects. 

Comments 19 comments - Aug 28, 2008 - * * * * *

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