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Drugs » Byetta

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Lilly Prepares to Launch Bydureon in US
Posted: Wednesday, July 20, 2011
Eli Lilly aims to bring its once-a-week diabetes injection Bydureon to US markets in the first half of next year.

Switching to Once-Daily Victoza(R) (Liraglutide) from Exenatide Further Improves Blood Sugar Control in Patients with Type 2 Diabetes
Posted: Sunday, April 04, 2010
Diabetes Care has published online the results of the Novo Nordisk (NVO) LEAD™ 6 extension study...

Special Newsflash: Exenatide Once Weekly -- FDA Update
Posted: Tuesday, March 16, 2010
Amylin, Lilly and Alkermes received a Complete Response Letter from FDA for Exenatide Once Weekly. New drug to be called BYDUREON (exenatide for extended-release injectable suspension).

In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.

Novo Nordisk receives US approval for Victoza®
Posted: Tuesday, January 26, 2010
Novo Nordisk receives US approval for Victoza® (liraglutide) for the treatment of type 2 diabetes.

Exenatide Once Weekly DURATION-5 Study Results Announced
Posted: Sunday, December 20, 2009
Eli Lilly and Company, and Amylin announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to BYETTA® (exenatide) injection taken twice daily, in patients with Type 2 diabetes.

Expanded Indication for Byetta to Include Monotherapy for Glucose Control
Posted: Monday, November 16, 2009
The FDA has expanded the indication and prescribing language for the Type 2 diabetes drug exenatide (Byetta), extending its approval to use as monotherapy for glycemic control in adults, but with precautions.

FDA: Byetta Label Revised to Include Safety Information on Possible Kidney Problems
Posted: Monday, November 02, 2009
For Immediate Release: Nov. 2, 2009: The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes.

Once-Weekly Exenatide Provides Glycemic Control and Weight Loss
Posted: Wednesday, June 17, 2009
Once-weekly exenatide (EQW) produces superior improvements in glucose control and body weight compared with maximum daily doses of sitagliptin and pioglitazone on background metformin, according to study results presented at the ADA 69th Scientific Sessions.

Exenatide Not Associated with Increased Rate of Acute Pancreatitis Compared to other Antidiabetic Drugs
Posted: Wednesday, June 17, 2009
Retrospective Cohort Study included more than 25,000 BYETTA patients accrued over three years.

DPP-IV Inhibitors and Increased GLP-1 Levels May Increase Pancreatitis Risk -- Metformin Can Negate Adverse Effects
Posted: Tuesday, May 12, 2009
A drug widely used to treat Type 2 diabetes may have unintended effects on the pancreas that could lead to a form of low-grade pancreatitis in some patients and a greater risk of pancreatic cancer in long-term users, according to researchers at UCLA , but the adverse effects can be negated when combined with an older diabetes drug.

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