Prequalification

WHO Awards Prequalification Status to the First UAE Approved Vaccine

The first ever vaccine approved by the UAE Ministry of Health (MOH) against highly contagious rotavirus has been recently awarded with a //prequalification status by the World Health Organization (WHO). It is the first time a vaccine against rotavirus gastroenteritis has received such clearance. ...

GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervical Cancer Vaccine

...ns 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...

Merck Announces Plans for Licensing Atripla Widely in Developing World

... is seeking to register its three-in-one fixed dose combination Atripla in 66 developing countries, in addition to seeking// World Health Organization prequalification for the product, the company announced on Friday. Atripla, which is a single tablet containing a daily dose of efavirenz, tenofovir and emtrici...

Prequalification in Medical Technology

Landmark Study for GSK's Cervical Cancer Vaccine Published in The Lancet

... in more than 20 additional countries including Japan and the United States. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007. About HPV and cervical cancer Women are at risk of HPV infection throughout their sexually active lives. Approximately 1...

GlaxoSmithKline Responds to FDA on CERVARIX(R) and Plans to Submit Final Study Data for Approval

...ns have been submitted in more than 35 additional countries including Japan. GSK also submitted the vaccine 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 an...

GSK Cervical Cancer Candidate Vaccine CERVARIX (R) Demonstrates Long-Term Protection for More Than Six Years

...applications have been submitted in 28 additional countries including Japan. GSK also submitted CERVARIX(R) to the World Health Organization (WHO) for prequalification in September 2007. GSK submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its cervical cancer candid...

New Analysis from 14 Countries Identifies Drug Access Priorities to Achieve 2010 AIDS Treatment Target

...ies that use flexibilities in trade law. -- National governments: Build local and regional drug regulatory capacity, make fuller use of the WHO drug prequalification process, and use flexibilities in international trade rules to secure the lowest possible drug prices. About the International Treatment Preparedn...

Prequalification in Biological Technology

CERVARIX(R) U.S. Regulatory Update

...s have been submitted in more than 20 additional countries including Japan. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007. Notes to Editors Cervical Health Facts - Worldwide, every two minutes a woman dies of cervical cancer; each year more ...

Pharmacyclics Announces Appointment of New Management Team and Board Director to Accelerate Its Future Growth

...co-founded the Critical Path Institute (a not for profit focused on regulatory innovation in Tucson AZ), EmergingMed, Inc. (a web based clinical trial prequalification and management service), and was part of the initial founding management of Cytokine Networks, Inc. Dr. Rice is currently an inventor on over 20 paten...