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

SAN DIEGO, Aug. 27, 2013 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the Light Study independent Data Monitoring Committee has recently confirmed that sufficient major adverse cardiovascular events (MACE) are expected to occur within the next two months, enabling the interim analysis to be conducted by early December and the potential resubmission of the Contrave® New Drug Application (NDA) by year end. The DMC also recommended that the Light Study continue as planned with no changes to the protocol.

"I'm proud of the progress made by our Light Study team," said Michael Narachi, Chief Executive Officer of Orexigen. "We remain focused on trial execution and launch preparation and look forward to the interim analysis and upcoming regulatory submissions."

Orexigen also today reiterated its plan to submit a Marketing Authorization Application (MAA) for Contrave® to the European Medicines Agency (EMA) in advance of the Light Study interim analysis and to have cardiovascular outcomes data from the Light Study available for the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions.

About Contrave (32 mg naltrexone sustained‐release (SR)/360 mg bupropion SR) for the treatment of obesity: In 2012, Orexigen screened more than 13,000 patients, enrolled more than 10,400 and ultimately completed recruitment of the Light Study with approximately 8,900 randomized patients. The primary objective of the double‐blind, randomized, placebo‐controlled Light Study, which Orexigen is conducting under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA), is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave.
'/>"/>

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:3/30/2015)... (PRWEB) March 30, 2015 With recent ... provided you the government, major companies are getting into ... governments setting future mandates for renewable energy production, many ... option. , Solara Power is a new solar distribution ... programs available that allow qualifying homeowners to enjoy the ...
(Date:3/30/2015)... 30, 2015  Multiple new research abstracts suggest walnuts ... health factors. From their impact on colon cancer and ... on both gut health and vascular health, the research ... latest understanding of walnuts, inner workings. Running March 28 ... this annual meeting attracts an international audience of over ...
(Date:3/30/2015)... 2015  NuGene International, Inc. ("NuGene") (OTCQB: NUGN), ... Inc. has added another internationally recognized researcher to ... an internationally recognized researcher in bio-inspired materials and ... Peking University, China , Professor ... of North Carolina, Chapel Hill. Following a postdoctoral ...
(Date:3/30/2015)... US-Australian drug discovery company, Novogen Ltd, (ASX:NRT; NASDAQ: ... University, on March 27 released pre-clinical data on experimental ... oral presentation by Professor Gil Mor MD ... Annual Scientific Meeting of the Society of Reproductive ... In both in vitro and in animal ...
Breaking Biology Technology:Solara Power Announces Residential Solar Power with No Up-Front Fees 2New Findings Support the Benefits of Eating Walnuts on Overall Health 2New Findings Support the Benefits of Eating Walnuts on Overall Health 3New Findings Support the Benefits of Eating Walnuts on Overall Health 4UCI Professor Zhibin Guan Joins NuGene Advisory Board 2UCI Professor Zhibin Guan Joins NuGene Advisory Board 3Yale University and Novogen Release Data on Cantrixil Mode of Action 2Yale University and Novogen Release Data on Cantrixil Mode of Action 3Yale University and Novogen Release Data on Cantrixil Mode of Action 4
... May 17 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc. ( ... company specialized in oncology and endocrinology, today announced that ... product designation from the Committee for Orphan Medicinal Products ... AEZS-108 for the treatment of ovarian cancer. AEZS-108, the ...
... , May 17 Soligenix, Inc. (OTC Bulletin Board: SNGX) ... results for the first quarter of 2010. , ... Soligenix,s revenues for the first quarter of 2010 ... the first quarter of 2009. The decreased revenues were primarily a result ...
... Sigma- Aldrich announces the retirement of David Julien , President – ... on his current role in January 2009 .  He served as President ... to January 2009 and before that in a number of senior ... , , , ...
Cached Biology Technology:Aeterna Zentaris Receives Positive Opinion for Orphan Medicinal Product Designation for AEZS-108 for the Treatment of Ovarian Cancer from the Committee for Orphan Medicinal Products of the European Medicines Agency 2Aeterna Zentaris Receives Positive Opinion for Orphan Medicinal Product Designation for AEZS-108 for the Treatment of Ovarian Cancer from the Committee for Orphan Medicinal Products of the European Medicines Agency 3Soligenix Reports First Quarter 2010 Financial Results and Reviews Accomplishments 2Soligenix Reports First Quarter 2010 Financial Results and Reviews Accomplishments 3Soligenix Reports First Quarter 2010 Financial Results and Reviews Accomplishments 4Soligenix Reports First Quarter 2010 Financial Results and Reviews Accomplishments 5Sigma-Aldrich (Nasdaq: SIAL) Announces Executive Management Changes: Retirement of David Julien and Promotion of Joseph Porwoll 2
(Date:3/16/2015)... 16, 2015 Between 16 ... present groundbreaking innovations in biometric identification at the ... .      (Photo: http://photos.prnewswire.com/prnh/20150316/735333 ... is well at the forefront: the company,s all ... in Germany . BiometricGate is ...
(Date:3/12/2015)... 2015 Beta Systems today ... access management (IAM) solution for a fixed price ... System,s new IAM package, customers benefit from the ... multiple IAM implementations across different industries. The new ... as any necessary services and consulting. It spans ...
(Date:3/11/2015)... 11, 2015   The Sync Project™ ... scientifically measure and harness music to improve health. ... and objective measurements of physiology, enabling the study ... in large populations. It is designed for medical ... perform rigorous studies and accelerate the discovery of ...
Breaking Biology News(10 mins):DERMALOG Presents its Latest Biometric Innovations at the Hannover CeBIT Exhibition, 16 - 20 March 2015 2DERMALOG Presents its Latest Biometric Innovations at the Hannover CeBIT Exhibition, 16 - 20 March 2015 3Beta Systems Fast Forward IAM Available Now: a Standardized IAM Package at a Fixed Price 2Introducing The Sync Project, a Global Collaboration Harnessing the Scientific Potential of Music for Health 2Introducing The Sync Project, a Global Collaboration Harnessing the Scientific Potential of Music for Health 3
... ITHACA, NY Commercial apple growers in the northeastern ... and insect invasions to tree nutrition and crop load. ... of integrated fruit production (IFP) and organic fruit production ... alternative markets. In a recent issue of HortScience ...
... Today,s most common cultivated strawberry, the familiar Fragaria x vananassa ... a chance hybridization of two wild strawberry species in Europe ... characteristics of both species, including the larger, firmer fruit of ... fruit of F. virginiana . The fact that ...
... the most important fruit trees in the world. Citrus has ... than 4,000 years. Until now, however, the exact genetic origins ... ), lemon ( C. limon ), and grapefruit ( C. ... from China has published a study in the Journal of ...
Cached Biology News:Integrated, organic production systems evaluated for 'liberty' apple 2New research expands genetic base of cultivated strawberry 2Genetic origin of cultivated citrus determined 2
XEDAR Antibody...
Rabbit Anti-JNK1/SAPK pan, Polyclonal Antibody...
Low melting point. Ideally suited for in gel enzymatic reactions. Gelling temp. 24-28C Melting temp. 65C. EEO 0.12 Resolution 0.5-20 kb; Rnase/Dnase: none detected....
Rabbit polyclonal to XTP4 ( Abpromise for all tested applications). entrezGeneID: 84299 SwissProtID: Q9BRT3...
Biology Products: