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:1/15/2014)... , Jan. 15, 2014  Bill Jacobs Automotive, a group of ... teaming up with the Heartland Blood Center and offering free ... The drive takes place Saturday, Jan. 18 at the Bill ... p.m. (Photo: http://photos.prnewswire.com/prnh/20140115/MN46637 )  The ...
(Date:1/15/2014)... FALLS, N.Y., Jan. 15, 2014   Niagara Thermal Products ... selected by Buffalo BioBlower Technologies LLC ("B3") as the ... Phase 2 award from the Army Corps of Engineers.  ... that kills all biological contaminants and destroys VOCs and ...
(Date:1/15/2014)... (PRWEB) January 15, 2014 Cynvenio, a ... management through the genomic analysis of tumor cells in ... Finder™, a web-based cancer decision support application powered by ... with Cynvenio’s ClearID™ genomic test, Therapy Finder will provide ...
(Date:1/15/2014)... Jan. 15, 2014 ­ RedBrick Health , a ... technology, today announces that EmblemHealth , the ... company, is now providing the RedBrick Compass health assessment, ... to all of its members. EmblemHealth is among the ...
Breaking Biology Technology:Join the Bill Jacobs Auto blood drive and receive a free oil change 2Niagara Thermal Products LLC Selected as Critical Supplier for Buffalo BioBlower Air Purification Systems 2Cynvenio Offers New Breast Cancer Therapy Finder Application for its ClearID Breast Cancer Genomic Test 2Cynvenio Offers New Breast Cancer Therapy Finder Application for its ClearID Breast Cancer Genomic Test 3EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 2EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 3
... not just because they sparkle. Engineers and physicists ... is as hard as an ice ball to the ... making it an ideal material or coating for seals, ... Carpick, associate professor in the Department of Mechanical Engineering ...
... Physicists at UC Riverside have made an accidental ... change how information in computers can be transported ... a property electrons possess that makes them behave ... the development of spin-based semiconductor technology such as ...
... Inc.,(Nasdaq: RDYN ) today announced that it has ... Ltd. for faropenem medoxomil (faropenem).,In conjunction with this decision, ... agreement with Asubio Pharma Co., Ltd. and Nippon,Soda Co. ... as a,result of the Company being unable to secure ...
Cached Biology Technology:University of Pennsylvania engineers reveal what makes diamonds slippery at the nanoscale 2Discovery by UC Riverside physicists could enable development of faster computers 2Discovery by UC Riverside physicists could enable development of faster computers 3Replidyne Terminates Faropenem Agreements 2Replidyne Terminates Faropenem Agreements 3
(Date:4/23/2014)... Alzheimer,s disease is the first cause of dementia and ... effective cure has yet been found. One of the ... the cellular mechanisms which cause alterations in nerve transmissions ... of the disease., Researchers from the Institute of Neuroscience ... cellular mechanism involved in memory consolidation and were able ...
(Date:4/23/2014)... University of Liverpool is leading a 2 million Food ... norovirus in food premises and industry workers. , ... In 2012 a batch of frozen strawberries infected ... in the authorities, understanding of which strains cause infection ... the bacteria. , Researchers will produce data ...
(Date:4/22/2014)... the University of Montana,s Wildlife Biology Program, co-wrote a research ... National Academy of Sciences on how streamwater chemistry varies ... Lowe and ... of Washington, the Cary Institute of Ecosystem Studies, the University ... examined 664 water samples collected every 10 meters along 32 ...
Breaking Biology News(10 mins):Loss of memory in Alzheimer's mice models reversed through gene therapy 2New research focuses on streamwater chemistry, landscape variation 2
... on a unique vertebrate called the sea lamprey shows that ... development. These genes are paradoxically lost all throughout the developing ... or PGCs. The PGCs can be thought of as embryonic ... generation of lampreys. Based on computational analysis, a significant number ...
... An inexpensive antifungal drug, thiabendazole, slows tumor growth and shows ... of Natural Sciences at The University of Texas at Austin ... frogs, mice and humans. Thiabendazole is an FDA-approved, generic ... 40 years as an antifungal. It is not currently used ...
... 2012) What comes naturally to most people to ... who have lost the full use of their limbs. New ... TIRR Memorial Hermann aims to help victims recover that ability ... from the National Institutes of Health (NIH) and the President,s ...
Cached Biology News:Research reveals unique solution to gene regulation 2Common antifungal drug decreases tumor growth and shows promise as cancer therapy 2Brain-wave-reading robot might help stroke patients 2Brain-wave-reading robot might help stroke patients 3
Rabbit polyclonal to HMGB1 (rating: ****) ( Abpromise for all tested applications). entrezGeneID: 3146 SwissProtID: P09429...
Pooled normal sreum with 0.1% sodium azide as preservative...
Mouse CXCR3 Allophycocyanin MAb (Clone 220803)...
Mouse P-Selectin/CD62P MAb (Clone 127933)...
Biology Products: