Navigation Links
Orexigen Therapeutics Prepares for the Light Study Interim Analysis Based on Direction from Data Monitoring Committee
Date:8/27/2013

nalysis and without the clinical study report for the interim analysis; the potential to accelerate the timing of the review of the Contrave NDA; the safety and effectiveness of Contrave; the potential for past Contrave clinical trials to predict the outcome of future Contrave clinical trials; the SPA and the protocol for the Contrave® cardiovascular outcomes trial, or Light Study; the potential for and timing of a submission of an MAA in the European Union; the potential for approval of the Contrave MAA by the EMA; and the potential to license commercial rights to Contrave outside North America. The inclusion of forward‐looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the possibility that the FDA determines not to initiate review of the Contrave NDA until it has received the complete study report for the interim analysis; the SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fails to comply with the agreed upon trial protocol; Orexigen's ability to conduct the Light Study and the progress and timing thereof, including risks associated with enrolling and retaining the appropriate patients in the Light Study; Orexigen's ability to demonstrate in the Light Study that the risk of MACE in overweight and obese patients treated with Contrave does not adversely affect Contrave's benefit‐risk profile; the potential that earlier clinical trials may not be predictive of future results in the Light Study; the potential for the FDA to not approve Contrave even after the resubmission with the MACE data; the potential for th
'/>"/>
SOURCE Orexigen Therapeutics, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Orexigen Therapeutics to Present at Upcoming Conferences
2. Orexigen CEO Michael Narachi Elected to PhRMA Board of Directors
3. Orexigen Therapeutics Commends the Campaign to End Obesitys Report on Long-term Returns of Obesity Prevention Policies
4. Orexigen Therapeutics Reports Financial Results for the First Quarter Ended March 31, 2013
5. Orexigen Therapeutics to Present at the Bank of America Merrill Lynch 2013 Health Care Conference
6. Technical Study: Vertex Pharma Inc., Orexigen Therapeutics Inc., MAKO Surgical Corp., and Alere Inc.
7. Cell Therapeutics, Inc. Reports Results of Annual Meeting of Shareholders
8. Nile Therapeutics Reports 2011 Third Quarter Financial Results
9. Nile Therapeutics Announces Top-Line Results in Clinical Trial Evaluating the Subcutaneous Infusion of Cenderitide, Meets Primary Endpoint
10. Fate Therapeutics Strengthens Its iPSC Platform
11. Amsterdam Molecular Therapeutics Provides Business Update for the Third Quarter 2011
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/1/2015)... The Dohmen Company today announced the ... as Chief Science Officer (CSO) of Dohmen Life ... Dr. Floyd will lead Dohmen,s growing regulatory consulting ... and post approval outsourced services in quality, regulatory, ... Floyd brings decades of experience leading global regulatory ...
(Date:9/1/2015)... ... September 01, 2015 , ... Knowledgent , the data and analytics ... advanced analytics utilizing data lakes in the healthcare industry. , As the Internet of ... of data over the last few years as more entities become technology enabled through ...
(Date:9/1/2015)... ... September 01, 2015 , ... ... Business Development, Asia Pacific. In this newly-created position, Gibbs will lead iLab’s business ... of iLab’s suite of tools. This entails not only introducing iLab to potential ...
(Date:9/1/2015)... ... September 01, 2015 , ... ... University of California Los Angeles, Boston University School of Medicine, Frederick National Laboratory ... PLOS One, the world’s first multidisciplinary Open Access journal. , Christopher Ryan ...
Breaking Biology Technology:Dohmen Life Science Services Appoints Eric Floyd, Ph.D. as Chief Science Officer 2Dohmen Life Science Services Appoints Eric Floyd, Ph.D. as Chief Science Officer 3New White Paper Explores Data Lake Opportunities in the Healthcare Industry 2iLab Solutions Hires Gerard Gibbs, Director of Business Development, Asia Pacific 2iLab Solutions Hires Gerard Gibbs, Director of Business Development, Asia Pacific 3Synedgen’s Director for Pharmaceutical Manufacturing Publishes New Research 2Synedgen’s Director for Pharmaceutical Manufacturing Publishes New Research 3
... Advanced Bionics agreed to,settle an administrative complaint arising ... Administration (FDA). The FDA asserted that Advanced,Bionics should ... before using a,second vendor for a particular component ... feedthru, contained a hidden weakness that allowed,a very ...
... Updates, BETHESDA, Md., July 18 Northwest,Biotherapeutics, ... NWBO), (the,"Company or NWBT"), today announced that Dr. ... will deliver a presentation updating,the Company,s progress in ... cancer, at the "Next Generation Vaccines" conference. The,conference ...
... Nature, in the simple form of a tree canopy, ... design complex systems to move substances from one place to ... materials. , Duke University engineers believe that an image of ... most efficiently control the flow of liquids in new materials, ...
Cached Biology Technology:Advanced Bionics Reaches Resolution With FDA, Settles Financial Suit 2Northwest Biotherapeutics to Present at Next Generation Vaccine Conference 2Tree branching key to efficient flow in nature and novel materials 2
(Date:8/18/2015)... -- Research and Markets ( http://www.researchandmarkets.com/research/9dmm6l/global_biometric ) has ... Authentication & Identification Market: Focus On Modality, Motility ... report to their offering. The ... expected to grow at an estimated CAGR of ... $25 billion (approximately) by 2020 as per the ...
(Date:8/12/2015)...   MedNet Solutions , an innovative SaaS-based eClinical ... research, is proud to announce that iMedNet ... technology platform, has led the way to significant and ... 2015.   Q2 2015 and Q1 2015 were, respectively, ... value sold in the company,s 15 year history.  In ...
(Date:8/12/2015)... , Aug. 12, 2015  New research unveiled ... attack Android phones to steal users, fingerprints. Information ... availability of fingerprint scanners on mobile devices, making ... To secure biometrics on mobile devices, HYPR Corp. ... these convenient authentication systems with strong cryptographic security. ...
Breaking Biology News(10 mins):Global Biometric Authentication & Identification Market 2015: Focus On Modality, Motility & Application - Estimation & Forecasts to 2020 for the $25 Billion Industry 2MedNet Solutions Experiences Explosive Corporate Growth 2HYPR Corp. Addresses Android Vulnerability That Exposes Ecosystem-wide Biometric Security Challenges 2HYPR Corp. Addresses Android Vulnerability That Exposes Ecosystem-wide Biometric Security Challenges 3
... (ESHRE) has published the first textbook for paramedics in the ... A Dutch textbook, in layout and depth of knowledge suitable ... level), was the basis for this European textbook. It is ... health. For a net price of EUR 30 ...
... 2010) If you were dying from cancer, would ... researchers from Virginia Commonwealth University Massey Cancer Center showed ... for genetic testing never received it despite that it ... research, "Exploring Hereditary Cancer Among Dying Cancer PatientsA Cross-Sectional ...
... BioNanomatrix, Inc., which is developing and commercializing breakthrough ... the nano Analyzer 1000 System at the ... from November 2-6, 2010 in Washington, D.C. ... intended for advanced analyses of DNA and other ...
Cached Biology News:Knowledge of genetic cancer risks often dies with patients, finds VCU Massey Cancer Center 2BioNanomatrix to Introduce nanoAnalyzer® 1000 System 2
ABgene® supplies a 94kDa ultra-pure recombinant thermostable DNA polymerase obtained by high level expression of the Taq DNA polymerase gene in E. coli....
... ultra-pure recombinant thermostable DNA polymerase obtained by ... polymerase gene in E. coli, Concentration: 5U/ul, ... Thermo Fisher Scientific, the world leader in ... to make the world healthier, cleaner and ...
Collected at a certified USDA establishment located within the United States. All final processing is done by Quad Five employees....
... This system uses the Adept CE 4100 ... Ultra-Fast Scanning UV/Visible detector for added flexibility and ... a trustworthy alternative to a photodiode array detection ... one detector is required for method development and ...
Biology Products: