Category: Cervical Cancer / HPV Vaccine

GlaxoSmithKline on Monday said it does not expect to receive FDA approval for its human papillomavirus vaccine Cervarix until late 2009, Reuters reports. GSK said it has decided to wait until results from a Phase III trial of the vaccine are available before seeking U.S. approval.

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VGX Pharmaceuticals, Inc. (VGX) announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for its DNA vaccine for cervical cancer therapy, VGX-3100. The Company expects to initiate the Phase I clinical study for VGX-3100 in patients in a multi-center study in the third quarter of 2008. […]

The Royal Society of Health (RSH) welcomes the decision to introduce a national HPV vaccination programme, but with reservations. Responding to the decision taken by the Department of Health last week to use ‘Cervarix’, one of two HPV vaccines on the market, Professor Richard Parish, RSH Chief Executive said: “The health benefits of […]

GlaxoSmithKline (NYSE: GSK) 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 […]

The board of the Global Alliance for Vaccines and Immunisation (GAVI) — a public-private partnership that invests in childhood vaccinations in developing countries — endorsed a $3.5 billion vaccine investment

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FDA has delayed a decision on Merck’s application to expand marketing of its human papillomavirus vaccine Gardasil to women ages 27 to 45, the company said Wednesday, the Newark Star-Ledger reports (Newark Star-Ledger, 6/26).

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In the United States alone, approximately three-and-a-half million women have abnormal Pap smear tests each year. More than a third of these women develop cervical dysplasia, also known as Cervical Intraepithelial Neoplasia (CIN), a condition caused by the sexually transmitted Human Papilloma Virus (HPV). Stages I & II are considered a precancerous abnormality, but not […]

GlaxoSmithKline announced on Wednesday that it has received a three-year contract from the United Kingdom’s Department of Health to supply the country’s immunization program with its human papillomavirus vaccine Cervarix, the Wall Street Journal reports. The health department’s goal is to vaccinate all girls ages 12 to 13 with Cervarix to protect against cervical cancer. […]

GlaxoSmithKline’s (GSK) cervical cancer vaccine, Cervarix TM, was confirmed as the UK Department of Health’s vaccine of choice for its national human papillomavirus (HPV) immunisation programme. The programme, which aims to protect against the two types of HPV that are responsible for approximately 70% of cervical cancers1, will start in September 2008 and will […]

Reacting to today’s announcement that the Department of Health is going to use the Cervarix HPV vaccine, that protects young women against cervical cancer in their nationwide vaccination programme, Julie Bentley, Chief Executive fpa said: “While we of course welcome the introduction

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