Navigation Links
New Drug Application for Exenatide Once Weekly Accepted for Review by FDA
Date:7/7/2009

SAN DIEGO, INDIANAPOLIS and CAMBRIDGE, Mass., July 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA).

Exenatide once weekly is an investigational sustained release medication for type 2 diabetes that is injected subcutaneously and administered only once a week. Exenatide is the active ingredient in BYETTA(R) (exenatide) injection, which is currently available in the U.S. and in many countries worldwide for people with type 2 diabetes who are unable to achieve good glycemic control with common oral therapies.

"Acceptance of the NDA submission for exenatide once weekly is an important milestone both in the exenatide development program and in the treatment of type 2 diabetes," said Orville G. Kolterman, M.D., senior vice president of research and development at Amylin Pharmaceuticals. "If approved, this therapy could fill an important unmet need for treating patients with type 2 diabetes with just one dose per week."

About Diabetes

Diabetes affects more than 23 million people in the U.S. 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 U.S. and results in 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
'/>"/>

SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. CEL-SCI Files Patent Application to Support Companys Treatment for More Virulent Strain of H1N1 Swine and Other Influenza Viruses
2. Strativas New Drug Application for Ondansetron Orally Dissolving Film Strip Accepted by FDA
3. ViroPharma Receives Complete Response Letter for Cinryze(TM) Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema
4. A New Era in the Application of Lab-on-a-Chip to Rapid Point-of-Care Diagnosis
5. U.S. FDA Accepts Aridol(TM) New Drug Application for Review
6. City of Baltimore to Evaluate New Generation Biofuels for Use in Boiler Applications
7. ZyGEM Releases Application Note Showing its DNA Extraction Kits Rapidly Produce High Yields of Quality DNA
8. Industry Expert Reveals Cutting Edge Biotechnology Science for Nutraceutical and Functional Food Applications
9. Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes
10. NeoStem Obtains Exclusive Worldwide License for Innovative Stem Cell Technology and Applications to Heal Chronic Wounds
11. BioSpecifics Technologies Corp. Announces FDA Acceptance of Biologics License Application With Priority Review for XIAFLEX(TM) for the Treatment of Dupuytrens Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... His Majesty Willem-Alexander, King of the Netherlands ... His Majesty Willem-Alexander, King of the Netherlands, has announced ... POET-DSM Advanced Biofuels’ Project LIBERTY cellulosic ethanol plant in ... will take part in the Grand Opening Ceremony to ... p.m. and tour the plant. POET-DSM is a joint ...
(Date:8/21/2014)... YORK , Aug. 21, 2014 Mathematic studies ... Harvard University , and funded by the Jeffrey ... cells within tumors can be visually identified for elimination. These ... growth. The study, which shows a topological map of what ... time in cancer research, for while tumor cells can be ...
(Date:8/21/2014)... 2014 Pursuit Solutions ( http://www.pursuit-solutions.com ... and services for Life Sciences sales and marketing ... of New Commercial Sales Models” by Peter Robinson, ... The article examines some innovative models used to ... tested in the pharmaceutical market. Robinson grades the ...
(Date:8/21/2014)... 2014 On Wednesday of last week RENU ... Redox Signaling molecules, became available for purchase in Australia and ... way that RENU 28 works is, if you think about ... the rate of cellular renewal within your body. If you ... that rate of cellular renewal. What RENU 28 does is ...
Breaking Biology Technology:His Majesty Willem-Alexander, King of the Netherlands, to Attend Project LIBERTY opening 2His Majesty Willem-Alexander, King of the Netherlands, to Attend Project LIBERTY opening 3Science Power Jeffrey Epstein and Harvard University Fund Project to Visually Stop Tumor Growth 2Pursuit's Peter Robinson Publishes "Grading Pharma's Use of New Commercial Sales Models" 2RENU 28 Skin Care Now Available in Australia and New Zealand 2
... DIEGO, Sept. 2 Halozyme Therapeutics,Inc. (Nasdaq: ... and,commercializing products targeting the extracellular matrix, today,announced ... President,Research, Michael J. LaBarre, PhD, Vice President, ... Legal., "Halozyme is committed to attracting, ...
... licenses ... STAMFORD, Conn., Sept. 2 Purdue Pharma L.P. ... to end the OxyContin(R) (oxycodone HCl controlled-release) Tablets,patent infringement ... the Southern District of New York., According to ...
... Biotech Inc.,("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that ... the Company is initiating a U.S.,Phase 2 ... in,combination with paclitaxel and carboplatin in patients ... or EGFR-activated tumours. The Principal,Investigator is Dr. ...
Cached Biology Technology:Halozyme Therapeutics Strengthens Management Team, Appoints Additional Experienced Executives 2Halozyme Therapeutics Strengthens Management Team, Appoints Additional Experienced Executives 3Halozyme Therapeutics Strengthens Management Team, Appoints Additional Experienced Executives 4Purdue Pharma L.P. Announces Resolution of OxyContin(R) Patent Lawsuit with Mallinckrodt Inc. 2Oncolytics Biotech Inc. Announces U.S. Phase 2 Combination Clinical Trial for Non-Small Cell Lung Cancer Patients with K-RAS or EGFR-Activated Tumours 2Oncolytics Biotech Inc. Announces U.S. Phase 2 Combination Clinical Trial for Non-Small Cell Lung Cancer Patients with K-RAS or EGFR-Activated Tumours 3Oncolytics Biotech Inc. Announces U.S. Phase 2 Combination Clinical Trial for Non-Small Cell Lung Cancer Patients with K-RAS or EGFR-Activated Tumours 4
(Date:8/21/2014)... tube connectors, designed by an international standards process, will ... According to an invited review published in the OnlineFirst ... NCP ), the official journal of the American Society ... will greatly reduce the occurrence of misconnection that can ... connectors, which are used to join medical devices, components, ...
(Date:8/21/2014)... the pancreas digesting itself resulting in severe abdominal pain, ... around 20,000 patients are diagnosed with the disease resulting ... treatment is restricted to intravenous fluid and nutritional support. ... Life Sciences, who led the research, said "The major ... stones and excessive alcohol intake combined with a high ...
(Date:8/20/2014)... University of Tennessee, Knoxville, research finds life can persist ... professor was part of a team that examined waters ... Antarctic ice sheet and found the extreme environment supports ... by Jill Mikucki and her colleagues has implications for ... in the solar system. The findings are published in ...
Breaking Biology News(10 mins):New feeding tube connectors will improve patient safety 2Insulin offers new hope for the treatment of acute pancreatitis 2University of Tennessee research uncovers subglacial life beneath Antarctic ice sheet 2
... and Canadian research team surveying mercury contamination in fish ... Canada has identified five "hotspots" where concentrations of the ... The team focused on levels of the potent neurotoxin ... took into account contamination in other fish, birds, and ...
... of thousands of heart patients to have high-tech devices implanted ... expensive devices are designed to shock damaged hearts back into ... 300,000 Americans each year. , But a new study finds ... ICDs, a large number won't -- and a simple heart-rhythm ...
... from grain, but the U.S. Department of Energy (DOE) would ... alternatives, such as paper pulp, sawdust, straw and grain hulls. ... by analyzing the DNA of a bacterium that can break ... also found in forestry by-products (including paper) and waste feedstocks. ...
Cached Biology News:Hotspots of mercury contamination identified in eastern North America 2Are one-third of costly implanted heart devices unnecessary? New study suggests yes 2Are one-third of costly implanted heart devices unnecessary? New study suggests yes 3McBride shows DNA detective work with paper-eating bacteria that 'glide' 2McBride shows DNA detective work with paper-eating bacteria that 'glide' 3
5X StabilCoat Immunoassay Stabilizer is a 5X concentrate solution of StabilCoat Immunoassay Stabilizer. The shelf-life of 5X StabilCoat Immunoassay Stabilizer is 2 years when stored at 4C. Product ...
... Yellow crystalline solid. PROTECT FROM LIGHT. Useful in ... required. Purity: ≥98% by TLC. Soluble in ... preparation of a 10 mM stock in DMSO is ... to H 2 O with rapid mixing (e.g. 10 ...
Monoclonal antibodies conjugated with rhodamine...
... Rhodopsin is a glycoprotein which is ... and reptiles. The rhodopsin protein is present ... Immunogen: Membrane preparation from ... This antibody specifically labels the axons andsynaptic ...
Biology Products: