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Recent News and Articles on the Keywords: cervical cancer + fda has + fda  Related to the article below (Last Update: 5/5/2008)

Merck warned by FDA over vaccine plant failings
In-PharmaTechnologist.com, UK -
By Phil Taylor 05-May-2008 - The US Food and Drug Administration (FDA) has sent Merck & Co a warning letter saying it has failed to correct a number of ...MRK
University Health Services near 1000th course of HPV vaccine
Princeton University The Daily Princetonian,  United States -
... genital warts and cervical cancer. In the two years since obtaining FDA approval and being released by Merck, however, the vaccine has faced tremendous ...

PR Web (press release)
Texas Oncology Reminds Women 'You're the Best, Get the Tests'
PR Web (press release), WA -
In fact, Texas Oncology has played an integral role in gaining Food and Drug Administration (FDA) approval for 24 of the latest 30 cancer therapies. ...
Merck Isn't Down For The Count, But The Punches Keep Coming
CNNMoney.com - Apr 29, 2008
And Merck can expect to see continued growth for newer products such as the Gardasil cervical cancer vaccine. Merck has applied for FDA approval of new uses ...MRK
Merck Receives FDA Warning Letter Over Problems at Pennsylvania Plant
Wall Street Journal - Apr 30, 2008
The products include cervical-cancer vaccine Gardasil and certain childhood vaccines. The letter, dated April 28, stems from an FDA inspection conducted ...MRK
Merck Gardasil Vaccine Plant Cited In FDA Warning Letter
Newsinferno.com, NY - May 1, 2008
... has received a warning letter from the Food & Drug Administration (FDA) regarding conditions at the plant where the company makes the cervical cancer ...MRK
FDA warns Merck to fix vaccine plant problems
The Associated Press - Apr 30, 2008
The agency on Wednesday released a warning letter sent to Merck's chief executive, Richard T. Clark, that states FDA inspectors determined manufacturing ...
Annals of Internal Medicine tip sheet for May 6, 2008, issue
EurekAlert (press release), DC - 49 minutes ago
Approved by the FDA in 1998 for treatment of adults with sickle cell disease, hydroxyurea remains the only approved disease-modifying therapy. ...
FDA warns Merck to fix vaccine plant problems
The Associated Press - Apr 30, 2008
Is also makes hepatitis A, hepatitis B and meningitis vaccines for children and adults, and Gardasil, to protect young women against cervical cancer. ...
FDA finds problems at Phila.-area Merck plant
Bizjournals.com, NC - Apr 30, 2008
Among the products manufactured at the plant are Gardasil, a vaccine to prevent cervical cancer; Vaqta, a hepatitis A vaccine; and Comvax and Recombivax, ...MRK
Source: Google News

… for the Use of Human Papillomavirus DNA Testing as an Adjunct to Cervical Cytology for Screening -
TC Wright, M Schiffman, D Solomon, JT Cox, F … - acogjnl, 2004 - acogjnl.highwire.org
... screening now that the FDA has approved its use. ... Institutes of Health?National Cancer
Institute, American Society of Colposcopy and Cervical Pathology (ASCCP ...

A Study of the Impact of Adding HPV Types to Cervical Cancer Screening and Triage Tests -
M Schiffman, MJ Khan, D Solomon, R Herrero, S … - jnci, 2005 - jnci.oxfordjournals.org
... 3?6). Several HPV test systems exist; so far, the FDA has approved one test that
targets 13 HPV genotypes that are known to cause cervical cancer (HPV16, 18 ...

Commentary: the new female condom--item 1 on a women's AIDS prevention agenda -
EL Gollub - American Journal of Public Health, 1993 - Am Public Health Assoc
... him, use the diaphragm or a cervical cap plus ... a prophylactic against sexually
transmitted disease, the FDA's response to the female condom has been lagging. ...

Real-Time Vital Optical Imaging of Precancer Using Anti-Epidermal Growth Factor Receptor Antibodies … -
K Sokolov, M Follen, J Aaron, I Pavlova, A Malpica … - Cancer Research, 2003 - AACR
... EGFR expression in living neoplastic cervical tissue, providing ... Since 1997, the FDA
has approved more than ... Herceptin, for metastatic breast cancer therapy (26 ...

The Potential of Human Papillomavirus Vaccines -
R Steinbrook - The New England Journal of Medicine, 2006 - nejm.org
A correction has been published: N Engl J Med ... major public health advance against
cervical cancer and other ... The Food and Drug Administration (FDA) is conducting ...

HPV DNA Testing in Cervical Cancer Screening Results From Women in a High-Risk Province of Costa … -
M Schiffman, R Herrero, A Hildesheim, ME Sherman, … - JAMA, 2000 - Am Med Assoc
... test, 24 which subsequently received FDA approval for ... Given that HPV testing has
been proposed for ... the major screening method for cervical cancer prevention in ...

American Cancer Society Guideline for the Early Detection of Cervical Neoplasia and Cancer. -
D Saslow, CD Runowicz, D Solomon, AB Moscicki, RA … - Journal of Lower Genital Tract Disease, 2003 - jlgtd.com
... Preliminary Recommendation. TOP. HPV DNA testing with cytology for primary
cervical cancer screening has not been approved by the FDA. ...

Technologic Advances for Evaluation of Cervical Cytology: Is Newer Better? -
KE Hartmann, K Nanda, S Hall, E Myers - Obstetrical & Gynecological Survey, 2001 - obgynsurvey.com
... The Food and Drug Administration (FDA) has approved two ... TriPath Imaging, Inc.), which
the FDA approved in ... part of the update on cervical cancer screening for ...

Prospects for Cervical Cancer Prevention by Human Papillomavirus Vaccination -
JT Schiller, DR Lowy - Cancer Research, 2006 - AACR
... It would be unethical to use cervical cancer as an ... initial infection and development
of invasive cancer is usually ... to the Food and Drug Administration (FDA; ref ...

Improving the evaluation of new cancer treatments: challenges and opportunities -
ML Rothenberg, DP Carbone, DH Johnson - cancer. J, 2001 - chem.missouri.edu
... Duarte-Franco, E. & Ferenczy, A. Cervical cancer: epidemiology, prevention ... or
first-line treat- ment of cancer and 53 ... drug approval, whereas the US FDA has not ...

Source: Google Scholar

FDA has questions on Glaxo cervical cancer vaccine

Last Updated: 2007-12-17 10:39:20 -0400 (Reuters Health)

By Ben Hirschler and Mark Potter

LONDON - GlaxoSmithKline Plc's cervical cancer vaccine Cervarix faces a delay in winning approval in the United States, putting it further behind Merck & Co Inc's rival product Gardasil, which is already available.

Glaxo, Europe's biggest drugmaker, said on Monday it had received a "complete response letter" from the U.S. Food and Drug Administration (FDA), which is issued when the regulator has completed the review of a medicine, but still has questions.

Analysts, who had been expecting the FDA to issue a decision on Cervarix by next month, said the setback would delay approval by at least a few months and possibly more than a year.

"GSK will work closely with the FDA to prepare its response, which it intends to submit to the agency as soon as possible," Glaxo said in a statement.

Cervarix is already approved in 45 countries, including the 27 member states of the European Union. But it is trailing Merck's Gardasil, which is already well established in the United States -- the world's biggest drug market.

"A Glaxo spokesman declined to comment on when a final U.S. decision on Cervarix might now be made.

In cases such as this, the regulator usually takes up to six months to respond, once it has received the answers to its questions. Glaxo is not disclosing what the outstanding questions are or how long they will take to answer.

Both Cervarix and Gardasil protect against cancer-causing strains of the sexually transmitted human papillomavirus (HPV) and are designed to be given to girls and young women. Gardasil targets four strains of HPV, while Glaxo's product targets two.

Copyright © 2007 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

 
 
 
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