Navigation Links
GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervical Cancer Vaccine
Date:12/17/2007

PHILADELPHIA, Dec. 17 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that it has received a complete response letter from the U.S. Food and Drug Administration related to its application for the cervical cancer vaccine, CERVARIX(R). A complete response letter is issued by FDA's Center for Biologics Evaluation and Research (CBER) when the review of a file is completed and questions remain to be answered prior to approval. GSK will work closely with the FDA to prepare its response, which it intends to submit to the agency as soon as possible.

"We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX(R) to the U.S. market."

The application filed for the GSK cervical cancer vaccine included safety, efficacy and immune response data from clinical trials involving almost 30,000 females 10 to 55 years of age from ethnically and racially diverse populations.

To date, CERVARIX(R) has been approved in 45 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 27 additional countries including Japan. GSK also submitted CERVARIX(R) to the World Health Organization (WHO) for prequalification in September 2007.

Notes to Editors

Burden of Cervical Cancer

Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.(1) In the United States, after breast cancer, cervical cancer is the second leading cause of cancer death in women ages 20 to 39.(2)

About GlaxoSmithKline
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. GlaxoSmithKline Responds to JAMA Articles
2. MedImmune Licenses Reverse Genetics Technology to GlaxoSmithKline for Use in Influenza Vaccine Development and Production
3. Congressional Black Caucus Foundation and GlaxoSmithKline Announce Supplier Business Initiative Study Results
4. AUDIO from Medialink and GlaxoSmithKline: A New Nasal Spray for Allergy Relief
5. Mylan Announces Settlement of Paroxetine Hydrochloride Extended-Release Tablets with GlaxoSmithKline
6. GlaxoSmithKline Aids California Fire Relief Efforts
7. Genmab and GlaxoSmithKline Initiate Ofatumumab Rheumatoid Arthritis Phase III Program
8. GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR(R) (lovastatin) from Merck & Co., Inc.
9. Pharmacopeia and GlaxoSmithKline Collaboration Identifies Two Additional Lead Compounds
10. GlaxoSmithKline Presents Innovative Neuroscience Pipeline
11. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/5/2015)... In 2014, the FDA approved 44 drugs, with ... scoring 4 drug approvals in the USA. The infectious ... drug products, followed by oncology therapy with 18% of ... CDK inhibitors keep on attracting large-cap pharmacos. Nivolumab and ... metastatic melanoma, and at present, they are being investigated ...
(Date:3/5/2015)... Alachua, FL (PRWEB) March 05, 2015 ... technology company focused on the peripheral nerve repair market, ... quarter ended December 31, 2014 compared to $2.98 million ... execution of its growth strategies. , “Our strong ... of our peripheral nerve repair products which is driving ...
(Date:3/5/2015)... 2015 HomeCEUConnection.com is proud ... extra savings on their nutrition CEUs. To ... and nutrition, HomeCEUConnection.com is offering 10% off ... code, NUTRITION2015 . , High Quality ... HomeCEUConnection.com provides high-quality continuing education courses for ...
(Date:3/5/2015)... March 05, 2015 TCS Healthcare Technologies ... for the population health management arena, is pleased to ... management software, ACUITY Advanced Care™ (ACUITY) version 7.20. The ... performance and the advantages of automation. , The webinar, ... will be led by Jeff Frater, RN, BSN, Director ...
(Date:3/5/2015)... (PRWEB) March 05, 2015 University ... university founded in 1904, has launched a new ... positive lifestyle changes. The Northwest Center for Lifestyle ... professionals, support community outreach, and conduct research in ... medicine, diet and nutrition. The center will target ...
Breaking Medicine News(10 mins):Health News:World Pharma Business and Large-Cap Companies Discussed by MP Advisors in In-demand Study Available at MarketPublishers.com 2Health News:World Pharma Business and Large-Cap Companies Discussed by MP Advisors in In-demand Study Available at MarketPublishers.com 3Health News:AxoGen, Inc. Reports 61% Revenue Growth for the 2014 Fourth Quarter 2Health News:AxoGen, Inc. Reports 61% Revenue Growth for the 2014 Fourth Quarter 3Health News:AxoGen, Inc. Reports 61% Revenue Growth for the 2014 Fourth Quarter 4Health News:HomeCEUConnection.com Offers Nutrition CEUs this March to Celebrate Nutrition Month 2Health News:Complimentary Webinar to Explore Enhanced Version of Premier Case Management Software 2Health News:Complimentary Webinar to Explore Enhanced Version of Premier Case Management Software 3Health News:University of Western States Launches Northwest Center for Lifestyle and Functional Medicine 2
... Anticipating the needs of,the future, Geneva College will ... in the nation., Drawing on Geneva,s long-standing ... the program offers students a M.S. degree in,Cardiovascular ... of obtaining a B.S. (in four years) or ...
... 28, 2008 Oxytocin was originally studied as the ... for breast-feeding. However, there is increasing evidence that ... bonding and maternal behaviors. A new study scheduled ... Biological Psychiatry now shows that one way oxytocin ...
... of Liverpool has found that hypnosis can slow down ... for those living with the condition. , Forensic psychologist, ... people living with dementia and compared the treatment to ... hypnosis compared to a type of group therapy in ...
... MASummer on Cape Cod is synonymous with a surge ... the MBL (Marine Biological Laboratory). For more than a ... from around the world to immerse themselves in biological ... organisms available for study and the wealth of experts ...
... more resistance, study found , , MONDAY, July 28 (HealthDay ... even act out when nurses or other caregivers use ... , Researchers who taped the interactions of nursing home ... residents often became more agitated and resistant to care ...
... LLC launches new website offering convenient http://www.terrimilen.com [Online Counseling ... the comfort of their own home or office. , ... ... to provide clients with an alternative to traditional therapy which requires ...
Cached Medicine News:Health News:Geneva Offers First Cardiovascular Technology Graduate Program in the Nation 2Health News:A hormone that enhances one's memory of happy faces 2Health News:LabBits: A media tip sheet from the MBL in Woods Hole 2Health News:LabBits: A media tip sheet from the MBL in Woods Hole 3Health News:LabBits: A media tip sheet from the MBL in Woods Hole 4Health News:Alzheimer's Patients React Poorly to 'Elderspeak' 2Health News:Alzheimer's Patients React Poorly to 'Elderspeak' 3Health News:Online Counseling and Life Coaching Practice Launches New Website 2
(Date:3/5/2015)... , March 5, 2015  Sanomedics, Inc. (OTC: SIMH, ... company focused on developing, manufacturing, and acquiring cutting-edge technology, ... Thermomedics, Inc., will be exhibiting at booth # 709 ... Conference (NAPNAP) taking place on March 11-13, 2015 ... The 36 th ...
(Date:3/5/2015)... March 5, 2015  Relmada Therapeutics, Inc. (OTCQB: ... the treatment of chronic pain, today announced the ... advisory roles. The panel of experts will provide ... efforts to advance the company pipeline of novel ... expertise in a range of areas including opioid ...
(Date:3/5/2015)... , March 5, 2015 LUNGevity ... the Food and Drug Administration,s (FDA) approval of ... Opdivo and other immunotherapy treatments add another critical ... harnessing the power of a patient,s own immune ... has been approved specifically for patients with squamous ...
Breaking Medicine Technology:Sanomedics to Showcase the Caregiver at National Association of Pediatric Nurse Practitioners Conference 2Sanomedics to Showcase the Caregiver at National Association of Pediatric Nurse Practitioners Conference 3Relmada Therapeutics Names Leading Clinicians and Researchers in Pain Therapy Development to Advisory Roles 2Relmada Therapeutics Names Leading Clinicians and Researchers in Pain Therapy Development to Advisory Roles 3Relmada Therapeutics Names Leading Clinicians and Researchers in Pain Therapy Development to Advisory Roles 4LUNGevity Foundation Applauds FDA Approval of Immunotherapy Drug Opdivo 2LUNGevity Foundation Applauds FDA Approval of Immunotherapy Drug Opdivo 3
... 7, 2011 Johnson & Johnson (NYSE: JNJ ... agreement to become a global sponsor of the 2014 FIFA ... Cup™ Sponsor. With this sponsorship, Johnson & Johnson ... ability to activate across their Consumer, Medical Devices & Diagnostics ...
... Health IT Services Group (HITSG) announced today that its ... this month, continuing its growth as the largest Electronic ... by nephrologists for nephrologists, the Acumen nEHR enables all ... patient information, so that regardless of who treats the ...
Cached Medicine Technology:Johnson & Johnson Announces Global Sponsorship of the 2014 FIFA World Cup Brazil™ 2Acumen nEHR Surpasses 1,000 Nephrology Providers 2
... The AEM Laparoscopic Instruments incorporate a layered ... are shielded and monitored to prevent stray ... instrument caused by insulation failure or capacitive ... protective shield built into all AEM Instruments ...
... Laparoscopic Instruments incorporate a layered design unique ... and monitored to prevent stray electrosurgical burns ... by insulation failure or capacitive coupling; a ... built into all AEM Instruments provides a ...
... AEM Laparoscopic Instruments incorporate a layered design ... shielded and monitored to prevent stray electrosurgical ... caused by insulation failure or capacitive coupling; ... shield built into all AEM Instruments provides ...
SOLOS Endoscopy shares your commitment to provide every patient with the highest quality care available through our ongoing research and development of advanced surgical instruments and diagnostic so...
Medicine Products: