Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


GSK Cervarix gets standard review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline's BLA for Cervarix gets 10-month standard review, setting a January 2008 user fee date for the human papilloma virus vaccine. The firm submitted the vaccine March 29 with a request for a priority review (1Pharmaceutical Approvals Monthly April 2007, In Brief). The decision gives Merck additional time to establish Gardasil, which launched in June 2006, as the only vaccine on the market to prevent human papilloma virus infection and associated diseases, such as cervical cancer. GSK hopes to position Cervarix as a superior product; a head-to-head trial comparing Cervarix to Gardasil is ongoing (2Pharmaceutical Approvals Monthly February 2007, p. 21). In April, Merck submitted an sBLA seeking additional claims for Gardasil for protection against vaginal and vulvar cancers...

You may also be interested in...

GSK’s Cervarix reaches FDA

GlaxoSmithKline is requesting a priority review of its human papillomavirus vaccine Cervarix, submitted March 29. The BLA is based on data from clinical trials in almost 30,000 females ages 10-55. One trial showed that Cervarix induced high antibody levels and more robust immune memory response when formulated with its proprietary AS04 adjuvant system, aluminum hydroxide plus MPL (monophosphoryl lipid A), than with aluminum hydroxide alone. GSK is looking to position Cervarix as superior to Merck's HPV vaccine Gardasil, which is formulated with aluminum hydroxide. Gardasil has been on the market since June, also under a priority review (1Pharmaceutical Approvals Monthly June 2006, p. 7)...

EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments

While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.

US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts