Navigation Links
GlaxoSmithKline Responds to FDA on CERVARIX(R) and Plans to Submit Final Study Data for Approval
Date:6/30/2008

LONDON and PHILADELPHIA, June 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of CERVARIX(R), its vaccine to prevent cervical cancer.

GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, received in December, 2007. In addition, given that final data from GSK's Phase III pivotal efficacy study, HPV-008, are expected to be available later this year, GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. GSK anticipates submitting these data in the first half of 2009. The timing depends on reaching a certain number of cases in order to conduct the final analysis. An FDA action on the application is expected to take up to six months following this submission. Interim data from this study were filed in the original application for the vaccine in March, 2007. The company does not expect that new clinical studies will be required for approval.

"Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for CERVARIX(R)," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "We continue to have positive and productive discussions with the FDA and remain confident in the vaccine's safety and efficacy profile. We look forward to bringing this important new cervical cancer vaccine to girls and women in the U.S."

To date, GSK's cervical cancer vaccine has been approved in 67 countries around the world including the 27 member countries of the European Union, Mexico, Australia,
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. GlaxoSmithKline Collaborates with National Cancer Institute to Make Large Body of Cancer Cell Genomic Data Available to All Cancer Researchers
2. GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic(TM)/Zunrisa(TM) (Casopitant)
3. GlaxoSmithKline Reports Further Progress of Oncology Portfolio
4. Paul Capital Healthcare Purchases Additional Royalty Interest in GlaxoSmithKlines Rotarix(R)
5. GlaxoSmithKline and Theravance Announce Start of Large Phase 2B ICS and LABA Studies for Asthma in the Horizon Program
6. Coley Pharmaceutical Group Receives $3.0 Million Milestone Payment from GlaxoSmithKline
7. New Data Show That GlaxoSmithKlines Rotarix(R) Could Be Given With Other Routine Infant Vaccines in the U.S.
8. GlaxoSmithKline Accelerates Review of Exelixis XL880
9. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
10. Roche responds to announcement of IDEAL hepatitis C trial results
11. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... , Aug. 20, 2014  The National Association ... latest results achieved by the real-time, pseudoephedrine (PSE) ... National Precursor Log Exchange (NPLEx), automatically blocks unlawful ... down methamphetamine offenders and make arrests. Data released ... Michigan blocked the sale of more ...
(Date:8/20/2014)... 2014 Reportlinker.com announces that a ... its catalogue: Personal Accident and ... Opportunities to 2018 ... provides in depth market analysis, information and ... health insurance segment, including: - The French ...
(Date:8/20/2014)... , Aug. 20, 2014 ... of the "Global Biosimilars/Follow-on-Biologics Market (Technology, Types, ... - 2020" report to their offering. ... market (types, applications and geography) - Size, Share, ... Report, Opportunities, Segmentation and Forecast, 2013 - 2020", ...
Breaking Medicine Technology:Michigan's Stop-Sale System Achieves Significant Results In Battle Against Meth 2Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 2Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 3Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 4Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 5Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 6Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 7Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 8Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 9Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 10Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 11Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 12Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 13Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 14Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 15Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 16Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 17Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 18Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 19Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 20Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 21Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 22Personal Accident and Health Insurance in France, Key Trends and Opportunities to 2018 23Global Biosimilars/Follow-on-Biologics Market (Technology, Types, Applications, Services and Geography) - Research Report, 2013 - 2020 2
... XI,AN, China , ... (OTC Bulletin Board: HFGB), specializing,in developing and producing ... food additives, today announced the receipt of its,European ... from Galenicum,Health S.L., a Spanish pharmaceutical company. This ...
... DIEGO , July 22 MabVax Therapeutics Inc., ... development of vaccine and antibody based therapies to address the ... first patients have been enrolled in a Phase II clinical ... vaccine to prevent or delay the recurrence of sarcoma. The ...
Cached Medicine Technology:Huifeng Bio-Pharmaceutical Technology Announces a New Spain Order 2Huifeng Bio-Pharmaceutical Technology Announces a New Spain Order 3MabVax Therapeutics Initiates Phase II Clinical Trial of Vaccine to Prevent Recurrent Sarcoma 2MabVax Therapeutics Initiates Phase II Clinical Trial of Vaccine to Prevent Recurrent Sarcoma 3
(Date:8/20/2014)... 21, 2014 Top10BestSEOHosting.com is a ... about hosting products. It is headed by a ... The site offers research-based information and factual studies ... in the current market. , Recently, Top10BestSEOHosting.com ... that GoDaddy and Bluehost are the ...
(Date:8/20/2014)... City, UT (PRWEB) August 20, 2014 ... Benefits Solution, announced the publication of a new ... Zane Benefits, many small business owners feel uncertain ... employees, their family, and their bottom line. , ... comprehensive FAQs, and helps businesses navigate their upcoming ...
(Date:8/20/2014)... (HealthDay News) -- A group representing U.S. obstetricians is ... shot. According to the American College of Obstetricians ... have upheld the safety and effectiveness of flu vaccination ... and can be particularly dangerous to pregnant women, as ... Dr. Laura Riley, chair of the college,s Immunization Expert ...
(Date:8/20/2014)... of women underwent breast reconstruction following a mastectomy ... reconstruction included being black, having a lower education ... M.D., of the Memorial Sloan Kettering Cancer Center, ... Health and Cancer Rights Act in 1998 guaranteed ... Still, most women who undergo a mastectomy do ...
(Date:8/20/2014)... August 20, 2014 Hundreds of Mirena ... of women who were allegedly injured due to spontaneous ... New Jersey’s Bergen County Superior Court, Bernstein Liebhard LLP ... August 15, 2014, the Court has established procedures regarding ... lawsuits that are part of the proceeding’s initial disposition ...
Breaking Medicine News(10 mins):Health News:New Reviews For Linux Web Hosting Suppliers Announced By Top10BestSEOHosting.com 2Health News:All Pregnant Women Need Flu Shot: Ob/Gyn Group 2Health News:Patient perspectives on breast reconstruction following mastectomy 2Health News:Mirena Lawsuit News: Case Management Order Issued in New Jersey Mirena Litigation, Bernstein Liebhard LLP Reports 2Health News:Mirena Lawsuit News: Case Management Order Issued in New Jersey Mirena Litigation, Bernstein Liebhard LLP Reports 3Health News:Mirena Lawsuit News: Case Management Order Issued in New Jersey Mirena Litigation, Bernstein Liebhard LLP Reports 4
... said that people were offered places in hotels it was ... defending their decision to house hospital patients in Aberdeen hotel ... Grampian said a doctor always took the decision as to ... outwith the city's Royal Infirmary. She said that as the ...
... is a fungal infection affecting mostly children in North America. ... affected by ringworm infections. //It is a highly contagious skin ... symptoms such as scaly scalp and hair loss which can ... household pets but in rare occasions it is passed easily ...
... the poor quality of drinking water for the cholera cases ... 222 cases have been reported.// ,"The capital has reported ... last year. But we are not triggering the warning bell ... deputy municipal health officer of Delhi. ,"Waterborne diseases ...
... in New Zealand have warned against using traditional Indian ... it was reported Friday.// ,"We wish to alert ... posed by a particular form of herbal remedy, namely, ... latest New Zealand Medical Journal. ,The eight ...
... Court has demanded an explanation from the medical superintendent (MS) ... from cancer got inflicted with AIDS after undergoing blood transfusion ... on why the relevant documents were not being made available ... that the blood transfusion was the business of the public ...
... of an influenza pandemic set into action by mutations of the ... handle// a mega crisis, and what plan of action can we ... an epidemic, eight Asia Pacific countries are teaming up next month ... of a global response to a pandemic. ,Australia and ...
Cached Medicine News:
... The first step to treatment is accurate ... an innovative and quick, patient-friendly tool designed ... urinary incontinence while minimizing patient discomfort. Designed ... features a new type of urethral pressure ...
...
...
...
Medicine Products: