Navigation Links
Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback
Date:12/11/2008

pproximately 800 patients and complete in 2010.

"We are confident that the strategy of the DURATION program will yield powerful data to support a strong launch for exenatide once weekly," said James Malone, M.D., global exenatide medical director, Eli Lilly and Company. "We believe the program will demonstrate the value of exenatide once weekly to physicians, patients and payers."

DURATION-3 completed enrollment in the fourth quarter. This approximately 450 patient, open-label, superiority study compares exenatide once weekly with insulin glargine on a background of oral agent therapy. Results are expected in the third quarter of 2009.

DURATION-2 completed enrollment in the third quarter of 2008. This 500 patient, double-blind, superiority study compares exenatide once weekly with TZD and a DPP-4 inhibitor on a background of metformin therapy. Results are expected in the second quarter of 2009.

DURATION is an acronym for the overall exenatide once weekly clinical program. It stands for "Diabetes therapy Utilization: Researching changes in A1C, weight and other factors Through Intervention with exenatide ONce weekly."

Exenatide once weekly uses a proprietary technology for long-acting medications developed by Alkermes. The technology encapsulates active medication into polymer-based microspheres that are injected into the body where they degrade slowly, gradually releasing the drug in a controlled manner to provide continuous therapeutic exenatide levels in plasma.

About Diabetes

Diabetes affects more than 23 million in the United States and an estimated 246 million adults worldwide.(i, ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.(iii)

According
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings
2. Wound Management Technologies, Inc. Announces Conference Plans in Boston and Additional Clinical Research on CellerateRx(R)
3. Epiphany Biosciences to Continue Phase 2 Shingles Study After Interim Analysis; Plans Follow-On Clinical Trial Studying Post-Herpetic Neuralgia (PHN)
4. CeNeRx BioPharma Finalizes Plans to Initiate Phase II Trials for Its Novel Antidepressant Agent Tyrima(TM) Using Innovative Brain Imaging Study
5. GlaxoSmithKline Responds to FDA on CERVARIX(R) and Plans to Submit Final Study Data for Approval
6. Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipolar Disorder
7. Quigley Announces Successful Poultry Study of Chickens With Infectious Bronchitis; Plans to Approach the Poultry Industry for Potential Commercialization
8. Clinsys(R) TPS Teams Provide Comprehensive Clinical Development Plans
9. Biodel Inc. Completes Enrollment of Two Pivotal Phase III Clinical Trials of VIAject(TM) and Plans Manufacturing Facility for VIAject(TM)
10. IDM Pharma Provides Update of Product Pipeline and Announces Plans to Evaluate Strategic Alternatives for the Company
11. Velcura Therapeutics, Inc. Reports Positive Pre-IND Meeting With FDA and Plans Early Clinical Trials for New Drug to Treat Multiple Myeloma Bone Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... 25, 2014  Arena Pharmaceuticals, Inc. (NASDAQ: ... update and report second quarter 2014 financial results before ... 1, 2014. That same day, Arena will host a ... (5:30 a.m. Pacific Time). The conference ... callers and 914.495.8552 for international callers. Please specify to ...
(Date:7/24/2014)... , July 24, 2014  Parnell Pharmaceuticals Holdings ... that will be added to Parnell,s already extensive ... Pty Ltd, a biotechnology company. The compounds now ... shown promise in bone regeneration and dermal regeneration, ... the compounds for the veterinary market with the ...
(Date:7/24/2014)... Deutschland, und MARSEILLE , ... , Weltweite Exklusivlizenz der ... QIAGEN die Entwicklung von Tests auf SF3B1-Mutationen, ... Neuer Test weist Mutationen des ... (myelodysplastischen Syndromen) einen günstigen Krankheitsverlauf vermuten lassen  ...
Breaking Medicine Technology:Arena Pharmaceuticals to Host Corporate Update and Financial Results Conference Call and Webcast on Friday, August 1 2Arena Pharmaceuticals to Host Corporate Update and Financial Results Conference Call and Webcast on Friday, August 1 3Parnell Acquires License for Intellectual Property and Rights to Develop Compounds for Bone and Dermal Regeneration 2Parnell Acquires License for Intellectual Property and Rights to Develop Compounds for Bone and Dermal Regeneration 3Parnell Acquires License for Intellectual Property and Rights to Develop Compounds for Bone and Dermal Regeneration 4QIAGEN erweitert Pipeline für die personalisierte Medizin um vielversprechende genomische Biomarker zur Prognosebestimmung bei Blutkrebsbehandlungen 2QIAGEN erweitert Pipeline für die personalisierte Medizin um vielversprechende genomische Biomarker zur Prognosebestimmung bei Blutkrebsbehandlungen 3QIAGEN erweitert Pipeline für die personalisierte Medizin um vielversprechende genomische Biomarker zur Prognosebestimmung bei Blutkrebsbehandlungen 4QIAGEN erweitert Pipeline für die personalisierte Medizin um vielversprechende genomische Biomarker zur Prognosebestimmung bei Blutkrebsbehandlungen 5
... Aug. 10 More than 33% of,pharmaceutical ... clinical,investigators 50% faster than their industry peers. ... trial costs while improving quality,by employing on-going ... research probing clinical trial excellence by,pharmaceutical consulting ...
... 10 Study results recently,published in the ... Imaging (BSGI) provides higher sensitivity for the,detection ... mammography or MRI and,can reliably detect small, ... Rachel Brem and colleagues at The George ...
Cached Medicine Technology:Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management 2BSGI Posts Higher Sensitivity than Mammography or MRI for the Detection of Ductal Carcinoma In Situ 2BSGI Posts Higher Sensitivity than Mammography or MRI for the Detection of Ductal Carcinoma In Situ 3BSGI Posts Higher Sensitivity than Mammography or MRI for the Detection of Ductal Carcinoma In Situ 4
(Date:7/25/2014)... 25, 2014 Bedros Keuilian has been ... in the country, and is considered the industry’s leading ... on his coaching website, RenegadeMarketing.com, he explains why information ... a good personal trainer. , “I’ve been really privileged ... leaders in the fitness industry and I’ve helped many ...
(Date:7/25/2014)... for Medical Oncology (ESMO), the leading pan-European association ... the proposed EU General Data Protection Regulation [1] ... significant burden to both doctors and cancer patients. ... stipulates ,explicit and specific patient consent, meaning that ... time research is planned in order to consult ...
(Date:7/25/2014)... Seattle, Wa (PRWEB) July 25, 2014 ... More Pdf review recently updated by Vkool.com, ... teach people how to treat some common ...     External hemorrhoids and internal hemorrhoids , ... after pregnancy with hemorrhoids ,     Very ...
(Date:7/25/2014)... As the category creator and world leader in healthy ... transform and improve individual lives worldwide through its exclusive and ... a successful Austin, Texas based "Xocai Activ Drink" author, is ... July to promote the up and coming mxicorp.com/company/igc Eric Worre ... has been a leader in the Network Marketing Profession for ...
(Date:7/24/2014)... York, NY (PRWEB) July 25, 2014 ... innovator in health care quality, has been appointed senior ... effective July 21, 2014. In his new role, he ... initiatives. , Dr. Ting has successfully led quality initiatives ... levels. Nationally, he led teams for the Door-to-Balloon Alliance, ...
Breaking Medicine News(10 mins):Health News:Fitness Marketing Expert Bedros Keuilian’s New Post Shares Why People Still Need Personal Trainers in the Age of Google 2Health News:Fitness Marketing Expert Bedros Keuilian’s New Post Shares Why People Still Need Personal Trainers in the Age of Google 3Health News:Is Europe putting cancer research at risk? 2Health News:Hemorrhoid No More Pdf Review Exposes Jessica Wright's Guide For Treating Hemorrhoids – Vkool.com 2Health News:Hemorrhoid No More Pdf Review Exposes Jessica Wright's Guide For Treating Hemorrhoids – Vkool.com 3Health News:Austin, Texas Based "Xocai Activ Drink" Author, Adam Paul Green, to Visit Niigata Japan to Promote mxicorp.com/company/igc Eric Worre Speaking Engagement 2Health News:Austin, Texas Based "Xocai Activ Drink" Author, Adam Paul Green, to Visit Niigata Japan to Promote mxicorp.com/company/igc Eric Worre Speaking Engagement 3Health News:Austin, Texas Based "Xocai Activ Drink" Author, Adam Paul Green, to Visit Niigata Japan to Promote mxicorp.com/company/igc Eric Worre Speaking Engagement 4Health News:NewYork-Presbyterian Hospital Names New Senior Vice President for Quality and Patient Safety 2Health News:NewYork-Presbyterian Hospital Names New Senior Vice President for Quality and Patient Safety 3
... little is known about these ,in situ, malignancies, experts say ... women with breast cancer in situ in the United States finds ... that number is expected to increase to more than 1 million. ... newly diagnosed breast cancers. It is the early stage of the ...
... , , , , ... stock will be included in the S&P 500 index following the company,s ... be added to the index on Sept. 1, coinciding with its first ... symbol "CFN." , , "Our inclusion in the ...
... test , TUESDAY, Aug. 25 (HealthDay News) -- In a ... found that saliva contains at least 50 microRNAs that could ... levels in the saliva of 50 people with oral squamous ... 50 microRNAs that may be associated with oral cancer. , ...
... cancer survivors decreases their risk of developing the most ... use is associated with a more than four-fold increased ... in the breast opposite, or contralateral, to the initial ... colleagues at Fred Hutchinson Cancer Research Center were published ...
... progressive resistance training also called strength training ... older adults to improve their health. A Virginia Tech ... physiology, and medicine is designing a program to help ... in order to prevent diabetes. "Much attention ...
... Aug. 25 One month ago, July 20, 2009, ... through all 48 states in the continental U.S. in 48 days, a total ... Nagle now has passed well beyond the halfway point on his route, bicycling ... In addition to eyeing a Guinness World Record with his ride, Nagle ...
Cached Medicine News:Health News:More Women Surviving After Early Breast Cancer 2Health News:More Women Surviving After Early Breast Cancer 3Health News:CareFusion Corp to be Included in S&P 500 Index 2Health News:Saliva May Help Spot Oral Cancer Early 2Health News:Long-term tamoxifen use increases risk of an aggressive, hard to treat type of second breast cancer 2Health News:Researchers evaluate resistance training for diabetes prevention 2Health News:Researchers evaluate resistance training for diabetes prevention 3Health News:College Student's '48 States in 48 Days' Bike Ride Moves Well Beyond the Halfway Point 2
Quatroloc Revision Hip System...
Severe revision options for the knee and hip...
The Precedent establishes a new generation of revision hip stems....
The Natural-Hip combines the surgical simplicity of a straight stem with many of the best features of an anatomic stem....
Medicine Products: