Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

Glaxo’s Emerging BRAF/MEK Melanoma Combo Threatens Roche’s Zelboraf

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Phase I/II data for Glaxo’s BRAF/MEK combination of dabrafenib and trametinib, both pending FDA approval as single agents, suggest compelling efficacy. The combination may see off-label use if the drugs are approved as monotherapies, though payment could be a big hurdle.

You may also be interested in...



Technical Difficulties Prevented Priority Review Of GSK Melanoma Drugs

GlaxoSmithKline withdrew priority review requests for its high-profile melanoma drugs Mekinist and Tafinlar as extensive problems with both the quality of the NDA data and the statistical analysis software in the electronic submissions emerged. Statistical reviewers called out sponsor for inadequate response to problems, wasting time.

Technical Difficulties Prevented Priority Review Of GSK Melanoma Drugs

GlaxoSmithKline withdrew priority review requests for its high-profile melanoma drugs Mekinist and Tafinlar as extensive problems with both the quality of the NDA data and the statistical analysis software in the electronic submissions emerged. Statistical reviewers called out sponsor for inadequate response to problems, wasting time.

An NME Surge After The Patent Cliff? Reinvention Of R&D Starts Paying Off In 2013 New Product Candidates

With more than 40 novel agents already pending at FDA, 2013 looks like a good bet to repeat the strong NME and novel biologic approval counts of 2012 and 2011. Big pharma and big markets dominate the 2013 slate so far, especially with diabetes, respiratory and central nervous system candidates.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS004983

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

Cancel