Navigation Links
Exenatide Clinical Data Analysis Shows No Increased Risk of Cardiovascular Events
Date:3/26/2009

de once weekly on major cardiovascular events, compared to standard of care with traditional antidiabetes medications. The global study will be sponsored by Amylin and Lilly, and active discussions are ongoing to have the study led by two academic research centers, The Diabetes Trial Unit at the Oxford Centre for Diabetes (Oxford, England) and Duke Clinical Research Institute at Duke University (Durham, N.C.). The steering committee for this study is chaired by Professor Rury Holman, FRCP, director, Diabetes Trial Unit, Oxford University, and Robert M. Califf, M.D., vice chancellor for clinical research and professor of medicine in the Division of Cardiology at Duke.

"There is a major unmet need for proven therapies that can help reduce the excess cardiovascular morbidity and mortality associated with type 2 diabetes," commented Professor Holman. "This trial is designed to determine the extent to which exenatide may reduce cardiovascular risk, in addition to lowering glucose."

Exenatide Once Weekly NDA Submission On Track By End Of Second Quarter 2009

The analyses to demonstrate comparability necessary for the regulatory submission of exenatide once weekly have been successfully completed and will be part of the New Drug Application (NDA) submitted to FDA. These analyses include data from the ongoing extension of the DURATION-1 study, and will be used to support comparability between intermediate-scale clinical trial material made in Alkermes' manufacturing facility and commercial-scale drug product made at Amylin's manufacturing facility.

"Both the manufacturing comparability data and the meta-analysis of the exenatide clinical trial database are key components of our submission. We believe that the material made at commercial scale is comparable to the clinical-scale material, and we are confident that we will have a strong submission package for exenatide once we
'/>"/>

SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7 8

Related biology technology :

1. New Data From Head-to-Head Phase 3 Trial Demonstrate That Liraglutide is More Effective Than Exenatide in Treatment of Type 2 Diabetes
2. Lilly and Amylin Enter Into Supply Agreement for Exenatide Once Weekly
3. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
4. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
5. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
6. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
7. PNH Patients Treated with Soliris(TM) Experienced Dramatic Reduction in Blood Clots During Clinical Trials
8. Clinical Data Acquires Epidauros Biotechnologie AG, Significantly Enhancing Proprietary Genetic Biomarker Portfolio
9. ExonHit Therapeutics: Allergan and ExonHits First Collaboration Compound to Begin Human Clinical Trials
10. Sunesis Pharmaceuticals Announces Reorganization to Focus Resources and Build Value in Clinical-Stage Programs
11. Lorus Advances Clinical Development of GTI-2040 Combined with Ara-C in Acute Myeloid Leukemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/16/2013)... (PRWEB) May 16, 2013 The ... by Global Cooling, Inc., Athens, OH, USA, won the ... by the International Society for Biological and Environmental Repositories ... award, given to one product annually, recognizes the company’s ... ultra-low temperature freezer. The award was presented to ...
(Date:5/16/2013)... 16, 2013 A new selection ... from Cole-Parmer is designed to meet the dynamic ... , The new Cole-Parmer® MS-3400 Centrifuges ... the lab. They ensure a powerful and complete ... separation. Their standard four-place swinging buckets hold 50-mL ...
(Date:5/16/2013)... SAN DIEGO , May 16, 2013  The ... the Association of Bioscience Financial Officers (ABFO) 2013 National Conference, ... will be held May 28-31 at the Hilton San ... finishing touches on this year,s conference and want to ... opportunity to attend," said Brandi Roberts ...
(Date:5/16/2013)... , May 16, 2013 /PRNewswire/ ... market research report is available in ... Competitor Analysis: Therapeutic Proteins ... http://www.reportlinker.com/p01171947/Competitor-Analysis-Therapeutic-Proteins-–-Biosimilars-Biobetters--Biosuperiors.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biopharmaceutical   ...   The new Competitive ...
Breaking Biology Technology:Stirling Ultracold Ultra-Low Freezer Wins 2013 Outstanding New Product Award at International Biorepository Conference, Sydney, Australia 2Cole-Parmer Offers Enhanced Selection of Centrifuges 2Registration Extended Until May 22 for Association of Bioscience Financial Officers (ABFO) 2013 National Conference -- San Diego 2Registration Extended Until May 22 for Association of Bioscience Financial Officers (ABFO) 2013 National Conference -- San Diego 3Registration Extended Until May 22 for Association of Bioscience Financial Officers (ABFO) 2013 National Conference -- San Diego 4Competitor Analysis: Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors 2Competitor Analysis: Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors 3Competitor Analysis: Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors 4Competitor Analysis: Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors 5Competitor Analysis: Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors 6Competitor Analysis: Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors 7Competitor Analysis: Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors 8
... Inc., a biotechnology company delivering breakthrough therapies in central ... will be participating at two upcoming healthcare investor conferences. ... at the 2nd Annual BIO Venture Conference on April ... Hotel in Boston, MA. On April 9 at 11:30 ...
... Inc., (OTC Bulletin Board: IXSBF; TSX VENTURE: IXS; ... generation of monoclonal antibodies based on its Dynamic Cross ... Company has entered into a loan facility with a ... to USD$2.5 million. The loan facility, subject to final ...
... March 25 Human Genome Sciences, Inc. (Nasdaq: ... subsidiary of Eisai Corporation of North America, today ... to discover, develop and commercialize therapeutic monoclonal antibodies ... specifically target antigens discovered by HGS.(Logo: http://www.newscom.com/cgi-bin/prnh/20080416/HGSLOGO ...
Cached Biology Technology:Accera, Inc. to Present at Upcoming Investor Conferences 2InNexus Biotechnology Announces a Loan Facility of up to USD$2.5 Million 2Human Genome Sciences and Morphotek(R), Inc. Announce Collaboration to Discover, Develop and Commercialize Antibodies for Oncology and Immunology 2Human Genome Sciences and Morphotek(R), Inc. Announce Collaboration to Discover, Develop and Commercialize Antibodies for Oncology and Immunology 3Human Genome Sciences and Morphotek(R), Inc. Announce Collaboration to Discover, Develop and Commercialize Antibodies for Oncology and Immunology 4Human Genome Sciences and Morphotek(R), Inc. Announce Collaboration to Discover, Develop and Commercialize Antibodies for Oncology and Immunology 5
(Date:5/16/2013)... scientists have shown a gene involved in neurodegenerative disease ... of the circadian clock. , In a study ... gene, called Ataxin-2, keeps the clock responsible for sleeping ... the rhythm of the fruit fly,s sleep-wake cycle is ... for the fly. , The discovery is particularly ...
(Date:5/16/2013)... 16, 2013 Integrated Biometrics patented LES ... custom thin film transistor camera introduces Sherlock, a ... image in the smallest and lightest form factor ... F Mobile ID FAP 45, Certified scanner is ... size and weight when compared to optical scanners. ...
(Date:5/16/2013)... neuroscientists from Canada and around the world are ... Canadian Neuroscience Meeting will showcase the latest in ... and reveal clues to understanding the disorders that ... research, and this meeting will showcase the best ... world," says Sam David, President of the Canadian ...
Breaking Biology News(10 mins):Gene involved in neurodegeneration keeps clock running 27th Annual Canadian Neuroscience Meeting, Toronto, May 20-24, 2013 2
... could create an evolutionary express lane that leads to the ... Pittsburgh and the University of Wisconsin at Madison have found. ... National Academy of Sciences ( PNAS ) that slight ... the when, where, and how much in gene productioncan activate ...
... University study has found that sunlight decreases the toxicity of ... United States every year. While golden algae is primarily ... and lakes, including Lake Whitney and Lake Waco in Central ... several environmental factors influence toxin production, but new research from ...
... Alexandria, VA The International and American Associations for ... symposium themed "Tissue Injury and Pulp Regeneration," held in ... the IADR Pulp Biology and Regeneration Group, and they ... Advances in Dental Research, an E-supplement to the ...
Cached Biology News:Leaky genes put evolution on the fast track, Pitt and UW-Madison researchers find 2IADR/AADR publish proceedings from Symposium on Tissue Injury and Pulp Regeneration 2
... sheer in-house demand is causing shortages in your ... This can cause unwanted distractions, problems and delays. ... your hard work and endeavour! Bring us your ... market it internationally. We work under ISO 9001 ...
... sheer in-house demand is causing shortages in your ... This can cause unwanted distractions, problems and delays. ... your hard work and endeavour! Bring us your ... market it internationally. We work under ISO 9001 ...
Topoisomerase I...
...
Biology Products: