Navigation Links
BYDUREON (TM) FDA Review Timeline Set with PDUFA Action Date of October 22, 2010
Date:5/6/2010

ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA, which has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON and BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.

About Diabetes

Diabetes affects more than 24 million people in the U.S. and an estimated 285 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 U.S. and costs approximately $174 billion per year in direct and indirect medical expenses (iii).

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen (iv). In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese (v). Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control (vi, vii).

About BYETTA® (exenatide) injection

BYETTA is the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert o
'/>"/>

SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related biology technology :

1. DJO Incorporateds Pending Merger With ReAble Therapeutics Clears U.S. Antitrust Review
2. Thoratec Announces HeartMate II(R) PMA Will be Reviewed by FDA Advisory Panel
3. Amyris Biotechnologies Co-Founder Neil Renninger Named to Technology Reviews Prestigious TR35 List of Top Young Innovators
4. Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial Following Independent Echocardiogaphic Data Safety Monitoring Board Review
5. Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial Following Independent Echocardiographic Data Safety Monitoring Board Review
6. AEterna Zentaris Announces Outcome of Managements Strategic Review
7. Thomson Scientific Publishes Who Is Making The Biggest Splash? - A Quarterly Review of Scientific Literature on Drugs and Therapies From April - June 2007
8. BioMS Medicals relapsing-remitting multiple sclerosis trial receives positive review from Data Safety Monitoring Board
9. Neurobiological Technologies, Inc. (Nasdaq: NTII) Q1/08 Review Issued By Scimitar Equity Research, Inc.
10. BioMS Medicals phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board
11. BioMS Medicals pivotal international multiple sclerosis trial receives positive review from Data Safety Monitoring Board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... 2014 Nuvilex, Inc. (OTCQB: NVLX) – According ... worldwide are living with diabetes, with  that number expected ... global market for diabetes treatments is approximately $500 billion.  ... died from pancreatic cancer.  Pancreatic cancer is the fourth ... the United States , and according ...
(Date:10/20/2014)... 20, 2014 The report “Pharmacy ... Systems, Packaging and Labeling Systems, Table-top Counters) by ... Global Forecasts & Trends to 2019” analyzes and ... in North America, Europe, Asia-Pacific, and the Rest ... tables and 30 figures spread through 300 pages ...
(Date:10/20/2014)... PARK, Calif. , Oct. 20, 2014 /PRNewswire/ ... today that the Company has signed a Notice ... of Regenerative Medicine (CIRM), effective October 1, 2014.  ... Clinical Development payments and the release of additional ... million CIRM grant award for clinical development of ...
(Date:10/20/2014)... 20, 2014  GenVec, Inc. (NASDAQ: GNVC ) ... Ph.D., from its board of directors effective on October 24, ... and served as its chairman from June 2006 to November ... and Corporate Governance and Audit Committees of the board.  ... decade of dedicated service to GenVec, and its stockholders," said ...
Breaking Biology Technology:Nuvilex Brief Analyst Report: Thinking Outside the Box by BrokerBank Securities, Inc. 2Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 2Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 3Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 4Asterias Biotherapeutics Announces Notice of Grant Award with CIRM for Phase 1/2a Clinical Trial of AST-OPC1 in Complete Cervical Spinal Cord Injury 2Asterias Biotherapeutics Announces Notice of Grant Award with CIRM for Phase 1/2a Clinical Trial of AST-OPC1 in Complete Cervical Spinal Cord Injury 3Asterias Biotherapeutics Announces Notice of Grant Award with CIRM for Phase 1/2a Clinical Trial of AST-OPC1 in Complete Cervical Spinal Cord Injury 4Zola P. Horovitz To Retire From GenVec Board 2
... 24 The Charlotte-Mecklenburg region,certainly has not been immune ... NC Free Clinic Association has seen their highest,demand for ... creator of,Charlotte,s premier health & wellness event, the Charlotte ... , "We can all have ...
... Extensive Experience In Molecular DiagnosticsSALT LAKE CITY, Feb. ... spine care through the development of molecular diagnostic ... has joined the executive management team as the ... Dr. Macina will report directly to Kenneth Ward, ...
... Ore. Researchers have identified the gene that ultimately ... that could some day lead to the repair of ... restoration or even the production of replacement teeth. , ... was already known to have several functions - in ...
Cached Biology Technology:Charlotte Anti-Aging Expo & Symposium Supports Free Clinics 2Axial Biotech Appoints Dr. Roberto Macina to Vice President of Research and Development 2Genetic discovery could lead to advances in dental treatment 2
(Date:10/16/2014)... infections and worldwide claims the lives of 160,000 ... University have succeeded in developing a promising vaccination ... , Xavier Saelens (VIB/UGent): "We discovered a new ... development of a novel approach to vaccination against ... small children and elderly people." , RSV: ...
(Date:10/15/2014)... a non-traditional biophysics textbook and it describes how life ... of discovery into biological systems and provides an understanding ... is about how our genes make proteins that control ... cells in an organism. It quantifies the principles of ... be found on both large and small scales. The ...
(Date:10/15/2014)... 44th Rosenstiel Award for Distinguished Work in Biomedical Science ... mechanisms of genomic instability and its implications for the ... alumnus to win the Rosenstiel Award; the first, Rod ... is the Charles A. Janeway Professor of Pediatrics and ... investigator at the Howard Hughes Medical Institute at Boston ...
Breaking Biology News(10 mins):New perspectives for development of an RSV vaccine 2New book about life as seen from physics 2Brandeis awards 44th Rosenstiel Award to pioneering geneticist Fred Alt 2
... turkeys died in Britain of cancer of the liver. Eventually, ... of aflatoxin as the cause of this mysterious 'turkey X' ... the most virulent natural carcinogenic substances. , The tasteless toxin ... hot, arid regions, in the south-west of the US and ...
... of people in southwest China suffer from potentially-crippling fluoride ... coal, say researchers. , The findings, from a study ... that the disease was caused by people burning fluoride-rich ... this belief, last year, the Chinese authorities invested 34 ...
... what many scientists thought, genetically modified (GM) corn has ... Mexico. , After analyzing tens of thousands of seeds ... from Mexico and the United States found no evidence ... surprised the researchers, said Allison Snow, a professor of ...
Cached Biology News:Corn grain mould used as pesticide 2Fluoride poisoning in China due to clay, not coal 2Genetically modified maize not found in southern Mexico 2
...
Request Info...
Human RUNX2/CBFA1 MAb (Clone 232902)...
... Peroxidase Conjugate, 2 ml. ... enzyme molecules for use ... situ hybridization applications.High specificity ... Labeling & Detection, Protein ...
Biology Products: