Navigation Links
GSK Regulatory Update on Avandia Following EMA and FDA Reviews
Date:9/23/2010

n and support from healthcare professionals and patients.  

Regarding clinical trials, the FDA has imposed a new post-marketing requirement (PMR) for GSK to commission an independent reajudication of the endpoints reported in the large, prospective, randomized, controlled study, RECORD. GSK will provide its full support for this review. The FDA-required TIDE study has been placed on full clinical hold by the agency.  TIDE is the only GSK-sponsored clinical trial using Avandia currently being conducted in the US and Europe.  GSK in conjunction with the TIDE steering committee will communicate this decision to local regulatory agencies, ethics committees and institutional review boards (IRBS).

Financial Information

Total Avandia sales in the first half of 2010 were 321m pounds Sterling (-18%); US 164m pounds Sterling (-23%); Europe 72m pounds Sterling (-17%); Emerging Markets 37m pounds Sterling (-5%); RoW 48m pounds Sterling (-6%)**.  As a result of the regulatory updates in both the US and EU, GSK now expects global sales of Avandia products to be in a range of approximately 100m pounds Sterling - 150m pounds Sterling in the second half of 2010 and with minimal annual sales thereafter. These estimates are net of customer returns of product previously sold.  Associated one-off costs in 2010 comprising stock write-offs, asset write-offs and other related one-off costs are currently expected to be approximately 100m pounds Sterling on a pre-tax basis. 

To access the full EMA announcement visit www.ema.europa.eu.  

To access the full FDA announcement visit www.fda.gov.

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For fur
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. EpiCept Reports Regulatory Progress on Ceplene(TM)
2. Wyeth Presents New Phase 3 Data and Updates Regulatory Timing for NDA Filing of Bazedoxifene/Conjugated Estrogens
3. Anesiva Defines Regulatory Pathway for Adlea with FDA
4. Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
5. EpiCept Provides Update on Clinical and Regulatory Progress with Ceplene(TM) and EpiCept(TM) NP-1 Cream
6. Northwestern Offers Clinical Research and Regulatory Administration Graduate Certificate Program
7. Gen-Probe Submits U.S. Regulatory Application for Additional Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
8. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
9. PulmoBioTech Announces Details of Its Regulatory Approval Experiments
10. Morria Biopharmaceuticals Plc Announces Regulatory Approval to Commence Phase II Clinical Study of MRX-4 in Allergic Rhinitis
11. XTENT Announces European Regulatory Update
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... , August 27, 2015 According ... Market by Type (Integrated, Standalone), by Deployment Mode (Web ... Physicians, Emergency Healthcare Service Providers), by Component - Global ... Systems Market is estimated at $501.1 Million 2014, and ... a CAGR of 7.6% from 2014 to 2019. ...
(Date:8/27/2015)... 2015  BioElectronics Corporation (OTC Pink: BIEL), the maker ... abstracts featuring the use of ActiPatch®, its novel musculoskeletal ... Congress of the European Pain Federation EFIC®, ... 2015. The Company will also be exhibiting at the ... Bagnato , department clinical and experimental rheumatology from the ...
(Date:8/27/2015)... --  Americord Registry , a private cord blood ... banking company, announced today the launch of their ... website makes the expecting parent,s cord blood banking purchase ... checkout process. Logo - http://photos.prnewswire.com/prnh/20150827/261520LOGO ... this service difficult to purchase online. We want to ...
Breaking Medicine Technology:Radiology Information Systems Market Worth $722.7 Million by 2019 2Radiology Information Systems Market Worth $722.7 Million by 2019 3Radiology Information Systems Market Worth $722.7 Million by 2019 4BioElectronics Selected to Present its Pain Research and Devices at the European Pain Federation Conference 2Cord Blood Bank Revolutionizes Process of Online Cord Blood Banking 2
... Va., Nov. 16 As a two-time cancer survivor, Bill Still ... Sentara Cancer Network first-hand. When Bill,s prostate cancer ... group with the help of a community outreach nurse at Sentara ... care delivery system, he was largely on his own. , Bill ...
... , MAPLE GROVE, Minn., Nov. 16 ... Treatment of L ipoproteins and I nflammatory ... Journal of Clinical Lipidology . The objective was to ... and Lipitor (atorvastatin calcium) 10 mg/day, given alone and then ...
Cached Medicine Technology:Sentara Cancer Network Earns National Accreditation 2New Data: Cholesterol Management Analysis of Upsher-Smith's Slo-Niacin(R) Tablets in Combination with Lipitor(R) 2New Data: Cholesterol Management Analysis of Upsher-Smith's Slo-Niacin(R) Tablets in Combination with Lipitor(R) 3New Data: Cholesterol Management Analysis of Upsher-Smith's Slo-Niacin(R) Tablets in Combination with Lipitor(R) 4
(Date:8/27/2015)... ... August 27, 2015 , ... Allegheny General Hospital ... 20 adult-only medical centers in the United States to receive international recognition for ... The Extracorporeal Life Support Organization (ELSO) , an international consortium of healthcare ...
(Date:8/27/2015)... ... August 27, 2015 , ... About 10 percent ... into the Gulf Coast, killing more than 1,800 people, displacing hundreds of thousands ... Georgia State University study. , While most people don’t develop persistent depression after ...
(Date:8/27/2015)... CA (PRWEB) , ... August 27, 2015 , ... ... & IoT Summit , scheduled for October 27-29, 2015 in San Jose, CA. ... the summit will primarily focus on the void that exists where battery development ...
(Date:8/27/2015)... ... August 27, 2015 , ... Zensah®, the premium ... Tennis player for Israel in the Women’s Tennis Association (WTA). Glushko competes in ... and recovery. , With a focus on technology and comfort, Zensah® has developed ...
(Date:8/27/2015)... CITY, Tenn. (PRWEB) , ... August 27, 2015 , ... ... LLC, DBA All Clear System. The agreement will enable both Johnson City, Tenn.-based firms ... All Clear System is a cloud-based safety product that caters to organizations in the ...
Breaking Medicine News(10 mins):Health News:International Organization Honors Allegheny General Hospital's Advanced Lifesaving Program for Cardiac and Respiratory Failure 2Health News:International Organization Honors Allegheny General Hospital's Advanced Lifesaving Program for Cardiac and Respiratory Failure 3Health News:International Organization Honors Allegheny General Hospital's Advanced Lifesaving Program for Cardiac and Respiratory Failure 4Health News:About 10 Percent of Mothers Experienced Depression Two Years After Hurricane Katrina, New Study Shows 2Health News:Infocast Hosting First Conference Dedicated to Powering Wearable Devices & the IoT 2Health News:Zensah® Compression Announces Partnership with WTA Tennis Professional Athlete, Julia Glushko 2Health News:Zensah® Compression Announces Partnership with WTA Tennis Professional Athlete, Julia Glushko 3Health News:Banc Intranets Forms Strategic Marketing Partnership with All Clear System 2Health News:Banc Intranets Forms Strategic Marketing Partnership with All Clear System 3Health News:Banc Intranets Forms Strategic Marketing Partnership with All Clear System 4
... Ind., Feb. 27 Zimmer Holdings, Inc. (NYSE: ... N. Casper, Executive Vice President and Chief Operating Officer ... its Board of Directors. Thermo Fisher Scientific, the ... equipment, supplies and services used in life sciences, healthcare, ...
... System, as Inventor of the Month for February 2009SAN ... ADSK ) has named Cochlear Bone Anchored Solutions, a ... in the development and manufacturing of implantable hearing solutions, ... February 2009.Cochlear successfully used Autodesk Inventor software ...
... by Communion and Liberation: D A T E: Friday, February 27, 2009 ... Gowan Hall ( Nursing-Biology Building ), ... 620 Michigan Avenue NE , Washington , ... Different Way of Facing H.I.V. -- From Sickness and Despair to a New Life: ...
... a Highly Effective and Affordable New Option to Help ... Derma Sciences, Inc. (OTC Bulletin ... announced today that its first BIOGUARD Barrier Dressings have ... for marketing and distribution. BIOGUARD will offer surgeons, ...
... Novalar Pharmaceuticals, Inc., a dental specialty pharmaceutical ... company,s premier dental pharmaceutical product. OraVerse is the ... accelerates the return to normal sensation and function ... and unnecessary lingering soft tissue anesthesia following routine ...
... University of Pittsburgh Medical Center (UPMC) and Paphos Plantations Ltd. (PPL) - ... collaborating to develop a world-class health care center in Paphos, Cyprus, designed ... and foreign visitors to this Mediterranean island. , ... Pittsburgh, PA and ...
Cached Medicine News:Health News:Zimmer Holdings Names Marc Casper to Board of Directors 2Health News:Zimmer Holdings Names Marc Casper to Board of Directors 3Health News:Superior Sound Amplifies Quality of Life for the Deaf and Hard of Hearing 2Health News:Superior Sound Amplifies Quality of Life for the Deaf and Hard of Hearing 3Health News:Superior Sound Amplifies Quality of Life for the Deaf and Hard of Hearing 4Health News:Derma Sciences Gains FDA Clearance for Novel BIOGUARD(TM) Barrier Dressing with NIMBUS(R) Technology 2Health News:Derma Sciences Gains FDA Clearance for Novel BIOGUARD(TM) Barrier Dressing with NIMBUS(R) Technology 3Health News:Derma Sciences Gains FDA Clearance for Novel BIOGUARD(TM) Barrier Dressing with NIMBUS(R) Technology 4Health News:Video: Novalar Announces the Launch of OraVerse(TM) the First Dental Anesthesia Reversal Agent 2Health News:Video: Novalar Announces the Launch of OraVerse(TM) the First Dental Anesthesia Reversal Agent 3Health News:Video: Novalar Announces the Launch of OraVerse(TM) the First Dental Anesthesia Reversal Agent 4Health News:University of Pittsburgh Medical Center to Manage New Health Center in Cyprus 2Health News:University of Pittsburgh Medical Center to Manage New Health Center in Cyprus 3Health News:University of Pittsburgh Medical Center to Manage New Health Center in Cyprus 4
The Snap-In Snap-Out-II Tip Inserts offer a large variety of configurations....
The ACMI™ line of laparoscopic hand instruments is designed to provide a wide selection of popular surgical devices to meet procedural needs....
This probe coagulates bleeders while suction channel with trumpet valve simultaneously evacuates smoke....
Bair Hugger temperature management units are the only forced-air warming systems that can be used with an integrated, cost-effective method of fluid warming...
Medicine Products: