Navigation Links
Orexigen Therapeutics Reports Business and Financial Results for the Third Quarter Ended September 30, 2013
Date:11/12/2013

ber, enabling the potential resubmission of the Contrave New Drug Application to the FDA by year end. In October 2013, Orexigen submitted a Marketing Authorization Application for Contrave to the European Medicines Agency.

Orexigen has licensed North American Contrave commercial rights to Takeda Pharmaceuticals. Orexigen owns Contrave rights in Europe and throughout the rest of the world outside of North America and will seek a partner to commercialize Contrave in those territories.

Empatic™, a fixed dose combination of bupropion SR and zonisamide SR, for the treatment of obesity: In a series of discussions with the FDA on the continued development of Empatic, the FDA stated that Phase 3 data for Empatic may be sufficient to support submission of an NDA without data from a cardiovascular outcomes trial. The FDA indicated that as long as the placebo‐subtracted changes in body weight, blood pressure and heart rate for Empatic are similar to or more favorable than the placebo‐subtracted changes observed with Contrave, and there are no signals of cardiovascular concern in the Empatic development program, reassuring results of a cardiovascular outcomes trial with Contrave will be sufficient. In addition, while the FDA reiterated the belief that the teratogenicity potential for zonisamide is very concerning, the FDA will allow Phase 3 studies of Empatic to include women of childbearing potential who have a Body Mass Index that meets the FDA definition of overweight (>27kg/m2) in the presence of at least one weight‐related comorbidity.

Orexigen owns worldwide rights to Empatic. Prior to initiating Phase 3 studies of Empatic, the Company plans to seek a collaboration partner to help fund further clinical development and, if approved, commercialization.

Conference Call This Morning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) The Orexigen management team will host a teleconference and webcast t
'/>"/>

SOURCE Orexigen Therapeutics, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Orexigen and Takeda Announce Multiple Contrave Data Presentations at the ObesityWeek Meeting in Atlanta
2. Orexigen Therapeutics Enters Into Agreement with Sanofi to Manufacture Contrave for Territories Outside North America
3. A Balanced Risk-Benefit Profile Will Propel Orexigen/Takedas Contrave to Become the Most Widely Used Emerging Therapy for the Treatment of Obese and Overweight Patients
4. Orexigen Therapeutics Announces Date of Third Quarter 2013 Financial Results Conference Call and Upcoming Presentation at Credit Suisse Healthcare Conference
5. Orexigen Therapeutics to Present at the Bank of America Merrill Lynch Global Healthcare Conference
6. Orexigen Therapeutics Announces European Filing Strategy and Reports Business and Financial Results for the Second Quarter Ended June 30, 2013
7. Orexigen Therapeutics to Host Second Quarter 2013 Financial Results Conference Call and Webcast
8. Orexigen Therapeutics Announces Upcoming Clinical Data Presentations at American Diabetes Association Annual Scientific Meeting
9. Orexigen Therapeutics to Present at the Jefferies 2013 Global Healthcare Conference
10. Orexigen Therapeutics to Present at the UBS Global Healthcare Conference
11. Orexigen Therapeutics Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2012
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/20/2014)... Calif. , Oct. 20, 2014  PneumRx, Inc. ... interventional pulmonology, today announced completion of enrollment in their ... RENEW Clinical Study is the FDA-approved IDE pivotal trial ... severe emphysema. It was anticipated that the ... February 2013, would take until the end of 2014 ...
(Date:10/20/2014)... BOSTON , Oct. 20, 2014  Indianapolis ... and Toronto -based 3D visualization ... the Congress of Neurological Surgeons Annual Meeting that ... technologies for brain surgery. The collaboration is the ... powerful combination to improve patient outcomes. NICO,s BrainPath® ...
(Date:10/20/2014)... 2014  ResMed (NYSE: RMD ) ... Exchange program, a comprehensive suite of software and ... other health care providers. ResMed ... patient information. It integrates valuable sleep and respiratory ... management platforms with customers, in-house or third-party electronic ...
Breaking Medicine Technology:PneumRx Completes RENEW Pivotal Trial Enrollment 2PneumRx Completes RENEW Pivotal Trial Enrollment 3Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 2Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 3Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 4Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 5ResMed Launches ResMed Data Exchange 2
... ST. PAUL, Minn., Oct. 28 M.B.A. students ... and CEO Eric Elliott speak about the history ... Therapeutics is a pharmacy benefit management company dedicated ... clients and members. In a speech ...
... 28, 2010 The enVision e ICU® Center ... Virginia Hospital Alliance (NVHA) Regional Hospital Coordinating Center to ... surge capabilities in the region.  Inova,s enVision e ... using eICU Program technology from Philips VISICU. ...
Cached Medicine Technology:Columbia University Students Learn About Pharmacy Benefit Management From Prime Therapeutics President and CEO 2NVHA and Inova Health System Utilize Philips VISICU eICU® Program to Increase Surge Capacity During All-Hazards Event 2NVHA and Inova Health System Utilize Philips VISICU eICU® Program to Increase Surge Capacity During All-Hazards Event 3
(Date:10/22/2014)... (PRWEB) October 22, 2014 Shriners Hospitals ... that will change the current location of Shriners Hospitals ... South Limestone across from the University of Kentucky Albert ... state-of-the-art ambulatory care center, owned and operated by Shriners ... orthopaedic needs of children and their families well into ...
(Date:10/22/2014)... Angeles, California (PRWEB) October 22, 2014 Hay ... 2.0: Move Beyond Addiction and Upgrade Your Life (Paperback; $10.82) ... field of Yoga & Recovery. This book is meant ... thrive in a life of recovery. , Recovery 2.0 ... the 12 Steps; Recovery 2.0 is a guide for what ...
(Date:10/22/2014)... Pass, OR (PRWEB) October 22, 2014 ... Southern California’s fresh water supply runs dangerously low, Southern ... change. Southern Oregon’s rivers, despite the lowest mountain snow ... even in late summer and early autumn.* That was ... authors of the new book “Hiking Southern Oregon,” during ...
(Date:10/22/2014)... Texas (PRWEB) October 22, 2014 ... of completing their continuing education at home or ... have access to 20 brand new, premium Seminar-on-Demand ... robust catalog of over 2,000 hours ... fully customize their educational experience. With such a ...
(Date:10/22/2014)... Although there are only 24 hours in a day, ... have trouble finding time within their busy schedules for exercise and ... of time to get in shape. Here are five ways you ... , Change Up Your Commute , Consider riding a bike ... exercise into your daily routine. If you must use your car ...
Breaking Medicine News(10 mins):Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 2Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 3Health News:Hay House Announces The Official Release of Recovery 2.0: Move Beyond Addiction and Upgrade Your Life 2Health News:Hay House Announces The Official Release of Recovery 2.0: Move Beyond Addiction and Upgrade Your Life 3Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 2Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 3Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 4Health News:Top Provider of Continuing Education at Home Releases 20 New Online Courses 2Health News:HealthGuideMD Presents Ways to Improve Your Exercise and Fitness 2
... study on sleep patterns in American women found that most of ... and physical health// , personal lives, professional work and driving safety. ... Foundation, studied about 1,003 adult women in ages 18 t0 65 ... get less than one or two nights of good sleep each ...
... Smailholm and the border areas has raised the concern ... village hall where drumming classes were being conducted. ... Sabre, to look into this matter. The finding revealed ... areas in Northumberland and the Borders, including Smailholm Village ...
... consulate in Hyderabad will start operations in a makeshift location ... permanent// facility in five years time. ,The US ... April so that work could begin to set up the ... by Henrietta H. Fore, under secretary of state for management, ...
... says a study that adds to a weight of evidence ... the peppers their zing. ,According to the latest ... National Chung Hsing University in Taiwan, capsaicin makes fat cells ... ,The result of the study is reported in the Journal ...
... from the renowned Salk Institute for Biological Studies, have discovered ... secretion will not only reduce insulin resistance, in animal models, ... high calorie diet. , The peptide in question ... are peptides produced in the insulin secreting cells ...
... 2007 -- A team of UCSB researchers, in collaboration ... of Los Gatos, California, has designed a novel ... the skin without the pain or bruising that deeper ... today in the Proceedings of the National Academy of ...
Cached Medicine News:Health News:Sleep Problems of Women 2Health News:US Consulate to Start Hyderabad Operations Next Year 2Health News:Scientists Explore Ways to Reduce Insulin Resistance by ‘handcuffing’ Gen 2Health News:Researchers Design Pulsed Mircrojet System to Deliver Protein Drugs Without Pain or Bruising 2
Autolensmeter with black/white monitor and no internal printer....
FF 450plus IR Fundus camera with Visupac / System 451. High-end system for visualizing even the finest detail and reliable diagnosis....
... CL-100 measures all types ... with improved precision. The ... senses multi-focal lenses with ... makes operation easier while ...
... is designed for fast and easy operation ... mode, the readings are automatically held when ... are automatically detected. The sophisticated alignment system ... The TL-2000A has been designed with a ...
Medicine Products: