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:3/27/2015)... ROCKVILLE, Md. , March 27, 2015  CASI ... dedicated to the acquisition, development and commercialization of innovative ... the global market with a commercial focus on ... the three and 12 months ended December 31, 2014.  ... of ($1.6 million), or ($0.05) per share, for the ...
(Date:3/26/2015)... SQI Diagnostics Inc. ("SQI" or the "Company") (TSX-V: SQD; ... including the appointment of auditors, its annual and special ... "Meeting") was adjourned, as previously disclosed on March 25, ... Toronto time). The date of the ... The Meeting will reconvene at the offices of the ...
(Date:3/26/2015)... March 26, 2015 Neogen Corporation (NASDAQ: ... the third quarter of fiscal 2015, which ended Feb. ... prior year,s $6,575,000. Earnings per share in the current ... Current year-to-date net income increased 17% over prior year ... or $0.56 per share, for the same period a ...
(Date:3/26/2015)... Ale Gicqueau, Founder and President of ... Affairs at Align Technology, on “ Conducting Postmarket Registries ... 2015 Global Conference and Exhibition on April 25th through ... During the poster presentation, Ale Gicqueau and Victor Chen ... Postmarket Registry, the requirements and resources to conduct the ...
Breaking Biology Technology:CASI Pharmaceuticals Reports 2014 Fourth Quarter And Full Year Financial Results 2CASI Pharmaceuticals Reports 2014 Fourth Quarter And Full Year Financial Results 3CASI Pharmaceuticals Reports 2014 Fourth Quarter And Full Year Financial Results 4CASI Pharmaceuticals Reports 2014 Fourth Quarter And Full Year Financial Results 5CASI Pharmaceuticals Reports 2014 Fourth Quarter And Full Year Financial Results 6SQI Diagnostics Inc. Announces Adjournment of Meeting 2Neogen reports 13% increase in net income 2Neogen reports 13% increase in net income 3Neogen reports 13% increase in net income 4Neogen reports 13% increase in net income 5Neogen reports 13% increase in net income 6Neogen reports 13% increase in net income 7Neogen reports 13% increase in net income 8Clinovo Presents at ACRP 2015 in Salt Lake City, Utah on April 25th-28th 2Clinovo Presents at ACRP 2015 in Salt Lake City, Utah on April 25th-28th 3
... Medical Center is passionate about improving the essence of ... methods of Bio-Identical Hormone Therapy available. If you suffer ... drive, memory loss, anxiety, joint pain, hot flashes, dry ... are you may have a hormone imbalance. ...
... molecule that may be a component in future rocket fuel. This ... best rocket fuels we have today. The discovery was made at ... rule of thumb is that for every ten-percent increase in efficiency ... more, the molecule consists only of nitrogen and oxygen, which would ...
... Novavax, Inc. (Nasdaq: NVAX ) and ... by Dr. Trudy Morrison, published in the January 2011 ... that a novel virus-like particle (VLP) vaccine candidate against ... virus challenge.  This vaccine candidate has been created with ...
Cached Biology Technology:HRC Medical Center Offers Patients Relief with Innovative Bio-Identical Hormone Replacement Therapy 2Discovery of new molecule can lead to more efficient rocket fuel 2NOVAVAX and University of Massachusetts Medical School Publish Preclinical Safety and Efficacy Study of a Respiratory Syncytial Virus (RSV) Virus-like Particle (VLP) Vaccine Candidate 2NOVAVAX and University of Massachusetts Medical School Publish Preclinical Safety and Efficacy Study of a Respiratory Syncytial Virus (RSV) Virus-like Particle (VLP) Vaccine Candidate 3NOVAVAX and University of Massachusetts Medical School Publish Preclinical Safety and Efficacy Study of a Respiratory Syncytial Virus (RSV) Virus-like Particle (VLP) Vaccine Candidate 4
(Date:3/23/2015)... 2015 SoundView Technology Group issues a new research ... ) Wocket smart wallet. SoundView was one of the selected user ... with the Wocket in multiple scenarios and outlets. ... other retailers, making both debit and credit card payments.  ... "If the company meets their plans in 2015, it would ...
(Date:3/23/2015)... OXFORD, Conn. , Mar. 23, 2015 NXT-ID, Inc. ... authentication company focused on the growing mobile commerce market, announces ... a new advertising campaign on CNBC television starting March 30 ... ads will commence airing in New York ... Executive Officer said: "We are excited about our new ad ...
(Date:3/20/2015)... OXFORD, Conn. , March 20, 2015 ... "Company"), a biometric authentication company focused on the growing ... Wocket® smart wallet is one of the products featured ... today, March 20th at 11:00 PM EST on the ... travels to Las Vegas , site ...
Breaking Biology News(10 mins):Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 2Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 3Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 4NXT-ID's Wocket Smart Wallet to Launch New CNBC Regional TV Ad Campaign 2NXT-ID's Wocket Smart Wallet to Launch New CNBC Regional TV Ad Campaign 3NXT-ID's Wocket Biometric Smart Wallet to Air on "I Want That" International CES Special 2NXT-ID's Wocket Biometric Smart Wallet to Air on "I Want That" International CES Special 3
... has approved wide-ranging new health claims for COLD-fX®, the ... extensive review, the Natural Health Products Directorate (NHPD) ?a ... efficacy and quality of natural health products (NHPs) ?has ... sell to the public with specific science backed claims. ...
... molecule called IQ-1 plays a key role in preventing ... specific cell types, allowing them to instead continue growing ... team of scientists who have recently joined the stem-cell ... the University of Southern California. Their findings are being ...
... are commonly prescribed for short-term relief of chronic back ... a review article by researchers at Yale School of ... abuse was reported in 24 percent of cases. ... medication, and opioid medications are used despite the concerns ...
Cached Biology News:Health Canada approves cold and flu medicine 2Scientists unlock mystery of embryonic stem cell signaling pathway 2