Navigation Links
CONBRIZA Receives Positive CHMP Opinion for the Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture
Date:2/19/2009

COLLEGEVILLE, Pa., Feb. 19 /PRNewswire-FirstCall/ -- The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), today adopted a positive opinion recommending to grant a marketing authorization for CONBRIZA(TM) (bazedoxifene) for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. CONBRIZA, an investigational medicine, is in development by Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).

The efficacy of CONBRIZA was studied in two multicenter, double-blind, randomized phase 3 clinical trials involving more than 9,000 postmenopausal women, comparing CONBRIZA to placebo and an active-control (comparator) drug. The prevention trial, conducted for two years in 1,583 patients, evaluated bone mineral density; and the treatment trial examined the incidence of new vertebral fractures in 7,492 patients for three years. Data from these studies indicated that the selective estrogen receptor modulator (SERM) characteristics of CONBRIZA were confirmed and further suggest a favorable endometrial profile. The most serious adverse reactions reported with CONBRIZA in these studies were venous thromboembolic events, which were more common than with placebo.

"If approved, Wyeth believes that CONBRIZA could be an important new treatment option for physicians and their patients," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals. "More therapeutic options are needed for postmenopausal women with osteoporosis, particularly for those at increased risk of fracture. Wyeth remains committed to women's health care, and CONBRIZA is an important affirmation of that commitment."

The CHMP is responsible for reviewing medicinal product applications for safety, quality and efficacy. The Commi
'/>"/>

SOURCE Wyeth Pharmaceuticals
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Osteotech Receives 13485:2003 ISO Certification; Company Meets International Standards for Medical Device Manufacturing
2. Cipher receives tentative FDA approval for extended-release tramadol capsules
3. China Shenghuo Receives Notice from NYSE Alternext US Regarding Listing Standards
4. A Drug That Receives Regulatory Approval for Cognitive Impairment Associated With Schizophrenia Would Earn a Higher Patient Share in the United States Than in Europe
5. i.HUG Foundation Receives International Grant: Hires a School Nurse to Improve Student Health and Learning
6. Emageon Receives Escrowed Funds and Terminates Merger Agreement
7. Children's National Medical Center Trauma Center Receives Highest Verification from American College of Surgeons
8. Abbott Receives FDA Clearance for New CELL-DYN(R) Emerald(TM) Hematology Instrument
9. Rising Medical Solutions Receives URAC Workers Compensation Utilization Management Accreditation
10. Executive Board Member of National Patient Advocate Foundation, Patient Advocate Foundation Receives National Institutes of Health 2008 Health Disparities Excellence Award
11. Nationwide Receives IBI/NBCH Healthy Workforce Productivity Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/29/2015)... Dot Hill can mark one more item off her ... Prince Woods retirement community is the oldest woman to have ... “It was great fun!”, she exclaimed. “I’ve always wanted to ... so they thought this would be ok.” , “We put on ... tunnel,” she described. “I don’t remember it being noisy, but ...
(Date:5/29/2015)... Tennessee (PRWEB) May 29, 2015 Jan Wooden ... belief in one thing above all else: God does no ... the subject of her son’s passing is titled “God Does ... person is confronted with great personal tragedy. , “My ... losing someone dear to you into something productive, something healing,” ...
(Date:5/29/2015)... 2015 A group of doctors have discovered ... national effort to teach this “new math” to children in ... been “sickened” by the recent implementation of Common Core Math ... it, Common Core is now a reality in children’s classrooms ... are now seeking ways to improve common core math training ...
(Date:5/29/2015)... 29, 2015 The print component of ... circulation of approximately 250,000 and an estimated readership of ... vast social media strategy, and across a network of ... digital version of the campaign, click here. ... publication. Inside, the actress, model and producer details her ...
(Date:5/29/2015)... Chicago, Ill (PRWEB) May 29, 2015 ... Care , a dozen medical pioneers recognized by a ... changed the course of cancer treatment. Honorees will be ... of Cancer Care™ Award Ceremony, held 8:30-11:00 p.m. CDT ... , The 2015 honorees are being recognized for groundbreaking ...
Breaking Medicine News(10 mins):Health News:Indoor Skydiving Brings Thrills to Seniors 2Health News:Turning grief from a child’s passing into virtue 2Health News:Doctors Discover a Cure for the Common Core 2Health News:OncLive's 2015 Giants of Cancer Care™ Awards Announced Today 2Health News:OncLive's 2015 Giants of Cancer Care™ Awards Announced Today 3Health News:OncLive's 2015 Giants of Cancer Care™ Awards Announced Today 4
... , , FRIENDSWOOD, Texas, ... which develops, manages and owns faith-based senior living facilities, today announced ... Inc. for the development of a new senior living facility in ... Heights , an 82-unit, $10 million senior living facility, should be ...
... , COLORADO SPRINGS, Colo., July 28 University ... Military Tuition Grant for university students serving on active duty in ... National Guard and reserves, who pursue a master,s or doctoral degree ... Active Duty Military Tuition Grant offers the following benefits, effective with ...
... , , SAN DIEGO, ... San Diego based medical device company, today announced that F. ... its Board of Directors. , , ... following graduation from San Diego State University in 1961. He ...
... , BATON ROUGE, La. and ALEXANDRIA, Va., ... Rx Access announced today the launch of the Together Rx Access(R) ... immediate and meaningful savings on prescription medicines and products right at ... collaboration will use existing State outreach channels to identify additional uninsured ...
... , BEDFORD, Mass., July 28 ... (Nasdaq: HOLX ), a leading developer, manufacturer and ... dedicated to serving the healthcare needs of women, today announced ... for women suffering from excessive menstrual bleeding--has passed the one ...
... , , , ... (pronounced ah-sigh-EE) has become America,s new super fruit of choice due ... of acai juice can contain a large amount of natural sugar, ... Healthy Balance line of Fit for Your Lifestyle(TM) ...
Cached Medicine News:Health News:TrinityCare Senior Living Announces Funding Agreement for Fifth Senior Living Facility 2Health News:TrinityCare Senior Living Announces Funding Agreement for Fifth Senior Living Facility 3Health News:TrinityCare Senior Living Announces Funding Agreement for Fifth Senior Living Facility 4Health News:University of the Rockies Introduces Military Tuition Grant 2Health News:F. Duwaine Townsen Joins SpectraScience Board of Directors 2Health News:F. Duwaine Townsen Joins SpectraScience Board of Directors 3Health News:F. Duwaine Townsen Joins SpectraScience Board of Directors 4Health News:The State of Louisiana and Together Rx Access Join Forces to Improve Prescription Access for Uninsured Residents 2Health News:The State of Louisiana and Together Rx Access Join Forces to Improve Prescription Access for Uninsured Residents 3Health News:The State of Louisiana and Together Rx Access Join Forces to Improve Prescription Access for Uninsured Residents 4Health News:Photos: One Million Patients Choose Hologic's NovaSure(R) System Over Hysterectomy 2Health News:Photos: One Million Patients Choose Hologic's NovaSure(R) System Over Hysterectomy 3Health News:Photos: One Million Patients Choose Hologic's NovaSure(R) System Over Hysterectomy 4Health News:Photos: One Million Patients Choose Hologic's NovaSure(R) System Over Hysterectomy 5Health News:Old Orchard Brands Introduces Low-Sugar Acai Juice Blend 2
(Date:5/29/2015)... , May 29, 2015 A six-hour certification ... is being presented at the Cannabis World Congress & ... New York, NY .  Taking place on Wednesday, ... dedicated day of education at the leading event on the ... Led by Clover Leaf University, the first cannabis ...
(Date:5/29/2015)... Research and Markets ( http://www.researchandmarkets.com/research/hgs483/cardiovascular ) ... report "Cardiovascular Drug Delivery - Technologies, Markets ... Drug delivery to the cardiovascular system is different ... anatomy and physiology of the vascular system; it ... the body. Drugs can be introduced into the ...
(Date:5/29/2015)... , May 29, 2015 ... announced the addition of the "Surgical/Operating Microscopes ... Forecast to 2020" report to their offering. ... global surgical microscopes market is poised to reach ... 2014, at a CAGR of 12.3% from 2015 ...
Breaking Medicine Technology:Cannabis Business Certification and Career Workshops Presented at New York Trade Show & Conference 2Cannabis Business Certification and Career Workshops Presented at New York Trade Show & Conference 3Cannabis Business Certification and Career Workshops Presented at New York Trade Show & Conference 4Global Cardiovascular Drug Delivery Market 2015 - Technologies, Markets and Companies 2Global Cardiovascular Drug Delivery Market 2015 - Technologies, Markets and Companies 3Surgical/Operating Microscopes Market by Application & End User - Global Forecast to 2020 for the $806 Million Industry 2
... , Jan. 27 Warner Chilcott plc ... complete response letter from the U.S. Food and Drug Administration (FDA) ... for its "low dose" oral contraceptive (also referred to as WC ... the third-party drug substance manufacturing facility and control testing laboratory used ...
... GREENSBORO, N.C. , Jan. 27 ... state-of-the-art CT and MR imaging systems to physician practices, ... into agreements with NeuIsys to plan, install, and service ... (CT) System. , Joining the NeuIsys family of ...
Cached Medicine Technology:FDA Issues Complete Response Letter for Low Dose Oral Contraceptive 2FDA Issues Complete Response Letter for Low Dose Oral Contraceptive 3NeuIsys Announces Entrance into the Gastroenterology Market 2
... third-generation immunoassay system combines continuous ... processing with a broad testing ... higher volume clinical laboratories to ... tests simultaneously, as well as ...
Architect i2000 is a flexible solution for your evolving laboratory providing high throughput and walkaway time with built-in flexibility....
The ADx system uses fluorescence polarization immunoassay technology for the detection of abused drugs and toxicology assays....
... The Bayer Immuno 1 provides ... immunoassay instrument with over 50 ... endocrinology, tumor marker, therapeutic drug, ... can be performed on a ...
Medicine Products: