Diabetes Drug Byetta May Aid Weight Loss in Obese Patients

Combined diet, exercise and injection had best results in study THURSDAY, June 11 (HealthDay News) -- Exenatide (Byetta), a drug normally used to treat diabetes, may also help non-diabetic obese people lose weight when combined with diet and exercise, new research has found. Researc...

Amylin Pharmaceuticals Diabetes Drug Byetta the Focus of California Lawsuit

Moore Labriola LLP and The Schmidt Firm, LLP represent Virginia man who developed pancreatitis; FDA seeks more stringent warnings. San Diego, CA (PRWEB) August 20, 2008 -- A Virginia man yesterday filed what is believed to be the first personal injury lawsuit stemming f...

Once-Weekly Exenatide Showed Statistical Superiority in Glucose Control Compared to BYETTA in Head-to-Head Study

- Both Groups Experienced Significant Weight Loss - - New Drug Application Filing Planned by the End of the First Half of 2009 - SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., Oct. 31 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: ...

Lilly Reports Solid Second-Quarter 2009 Results, Raises EPS Guidance

...quarter of 2009 includes $114.6 million of byetta revenue and $99.7 million of Erbitux revenue. ...orable impact of foreign exchange rates. byetta ((R)) Lilly reports in collaboration revenue i...n in the U.S., and in product sales 100 percent of byetta sales outside the U.S., and its sales of...

Amylin Pharmaceuticals Reports Second Quarter Financial Results

...f $200.3 million, consisting of $177.5 million for byetta and $22.8 million for SYMLIN for the same period i...lly) due to decreased spending associated with the byetta and exenatide once weekly development programs. ... We believe all of these activities will help grow byetta today, and will position exenatide once weekly for...

New Diabetes Drug Shows Promise in Trial

... than those taking Byetta, the researchers report. byetta was approved by the U.S. Food and Drug Administrat...either liraglutide at 1.8 milligrams once daily or byetta at 10 micrograms two times per day. All of the par...erimental drug was also more than twice as good as byetta at reducing mean fasting blood glucose levels. On ...

Amylin Pharmaceuticals to Present Compelling Efficacy and Safety Data From Diabetes Programs at ADA 2009

...ly increased to the recommended doses. About byetta (R) (exenatide) injection byetta is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. byetta exhibits many of the same effects as the human inc...

The Launch and Uptake of More Than 20 Novel Drugs Over The Next 10 Years Will Drive $12.5 Billion Growth in the Type 2 Diabetes Market

...nd existing DPP-IV inhibitors and GLP-1 analogues - such as Merck's Januvia, Bristol-Myers Squibb/AstraZeneca's Onglyza and Amylin/Eli Lilly/Alkermes' byetta LAR - hold the greatest promise for type 2 diabetes because these drug classes improve upon key areas of safety and efficacy. DPP-IV inhibitors have a...

Lilly Reports Strong First-Quarter 2009 Results

...nfavorable impact of foreign exchange rates. byetta (R) Lilly reports in collaboration revenue its 5...n in the U.S., and in product sales 100 percent of byetta sales outside the U.S., and its sales of byetta pen delivery devices to its partner, Amylin Pharma...

Amylin Pharmaceuticals Reports First Quarter Financial Results

...f $178.7 million, consisting of $158.5 million for byetta and $20.2 million for SYMLIN for the same period i...st-sharing payments from Eli Lilly and Company for byetta and exenatide once weekly development expenses. ... primarily reflects lower promotional spending for byetta and SYMLIN and the Company's reduced cost structur...

Byetta in Medical Technology

Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009

...erienced at least one CV event was 2.0 percent for byetta and 2.6 percent for the comparator group; the relative risk between byetta and the comparator group was 0.69 with a 95 percen...ted to have data that showed patients treated with byetta had no increased risk of cardiovascular events and...

Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 2009

...onsistent with the previously reported profiles of byetta and exenatide once weekly. About Diabetes ...and sustain glycemic control.(vi,vii) About byetta (R) (exenatide) injection byetta is the first and only FDA-approved incretin mimeti...

Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly

...and sustain glycemic control.(vi,vii) About byetta (R) (exenatide) injection byetta is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. byetta exhibits many of the same effects as the human inc...

Human Genome Sciences Reports Substantial Progress Toward Commercialization and Announces 2009 Goals at JPMorgan Healthcare Conference

... including a randomized Phase 2b dose-ranging trial of Syncria in patients with type 2 diabetes, which included a comparator arm of patients receiving byetta (exenatide). HGS expects an update from GSK in the first quarter of 2009 regarding Phase 3 development of Syncria. Syncria is a novel long-actin...

Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback

... About BYETTA(R) (exenatide) injection byetta is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. byetta exhibits many of the same effects as the human inc...concert on the stomach, liver, pancreas and brain. byetta is approved by the FDA for use by people with type...

After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008

...can Diabetes Association (ADA) in San Francisco. byetta is indicated as adjunctive therapy to improve glyc... were treated with exenatide once weekly 2.0 mg or byetta twice daily as outlined in the approved label subc...remained on exenatide once weekly or switched from byetta to exenatide once weekly for an additional 22 week...

Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight

...FPG -42+/-3 mg/dL) from baseline and compared with byetta (-1.5%+/-0.08, A1C and -25+/-3 mg/dL, FPG). Patien...can Diabetes Association (ADA) in San Francisco. byetta is indicated as adjunctive therapy to improve glyc... were treated with exenatide once weekly 2.0 mg or byetta twice daily as outlined in the approved label subc...

Monotherapy BYETTA(R) (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes Experienced Improved Glycemic Control and Weight Loss

...0 weeks. About BYETTA(R) (exenatide) injection byetta is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. byetta exhibits many of the same effects as the human inc...concert on the stomach, liver, pancreas and brain. byetta is approved by the FDA for use by people with type...

One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function

...ectively). About BYETTA(R) (exenatide) injection byetta is the first in a class of drugs called incretin mimetics for the treatment of type 2 diabetes. byetta exhibits many of the same effects as the human inc...concert on the stomach, liver, pancreas and brain. byetta is approved by the U.S. Food and Drug Administrati...

One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function

...ectively). About BYETTA(R) (exenatide) injection byetta is the first in a class of drugs called incretin mimetics for the treatment of type 2 diabetes. byetta exhibits many of the same effects as the human inc...concert on the stomach, liver, pancreas and brain. byetta is approved by the U.S. Food and Drug Administrati...

Byetta in Biological Technology

Surveyed Experts Indicate That Byetta LAR and Victoza Have Advantages Over Actos in the Treatment of Type 2 Diabetes

Byetta LAR Will Earn Decision Resources' Clinical Gold Standard Status for Type 2 Diabetes in 2012, According to a New Report from Decision Resources WALTHAM, Mass., March 24 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and heal...

Amylin Pharmaceuticals and Eli Lilly Provide Context for FDA Alert for BYETTA

SAN DIEGO and INDIANAPOLIS, Aug. 26 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ) and Eli Lilly and Company (NYSE: LLY ) in a conference call today provided context and additional information regarding the August 18, 2008 U.S. Food and Drug Administration (FDA) updat...

New Drug Application for Exenatide Once Weekly Accepted for Review by FDA

...and sustain glycemic control.(vi,vii) About byetta (R) (exenatide) injection byetta is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. byetta exhibits many of the same effects as the human inc...

Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes

...alysis of primary cardiovascular events across the byetta clinical database. DURATION-1 was designed to test...nts treated with BYETTA. Exenatide once weekly and byetta were both associated with an average weight loss o...inical studies of three months or greater from the byetta database showed no increased risk of cardiovascula...

Amylin Pharmaceuticals Announces a New Sales Approach to Better Target the Diabetes Market

... end of 2010, while continuing to position the company to increase sales of byetta and SYMLIN and bring exenatide once weekly to market as quickly as possible...BYETTA, SYMLIN and/or exenatide once weekly and the revenues generated from byetta and/or SYMLIN may be affected by competition; unexpected new data; safety a...

Amylin Pharmaceuticals Provides Shareholders with Update Regarding Recent Developments

...elease due to a number of risks and uncertainties, including the risk that BYETTA, SYMLIN and/or exenatide once weekly and the revenues generated from byetta and SYMLIN may be affected by competition; unexpected new data; safety and technical issues; clinical trials, including the DURATION-2 clinical trial ...

Exenatide Clinical Data Analysis Shows No Increased Risk of Cardiovascular Events

...and sustain glycemic control.(vi,vii) About byetta (R) (exenatide) injection byetta is the first and only FDA-approved incretin mimetic for the treatment of type 2 diabetes. byetta exhibits many of the same effects as the human inc...

Amylin Pharmaceuticals Appoints Vincent Mihalik Senior Vice President, Sales and Marketing and Chief Commercial Officer

...aid Daniel M. Bradbury, President and Chief Executive Officer, Amylin Pharmaceuticals. "Vince will add significant value to Amylin as we look to grow byetta and SYMLIN revenue and finalize our commercial plans for exenatide once weekly. As an integral part of our executive committee, we look forward to the...

Amylin Pharmaceuticals Highlights 2009 Value Creation Opportunities

... Gain approval for an expanded indication of byetta as a monotherapy, finalize label updates and retur... to growth Leverage knowledge gained from byetta to submit the New Drug Application (NDA) for exena... Bradbury added, "Our priorities are clear: Grow byetta and SYMLIN revenue, submit the NDA for exenatide o...

Lilly Highlights Transformation Strategy for Wall Street, Reviews Robust Pipeline and Sets 2009 Financial Guidance

...monotherapy is currently awaiting the FDA's final review. Outside the U.S., byetta continues to be launched in new markets. In 2008, byetta has been launched in France, Italy, Spain, Australia, Brazil and Mexico. Fu...