Roche's Vemurafenib Filed With Companion Diagnostic In Tow
This article was originally published in The Pink Sheet Daily
Executive Summary
Roche/Genentech seeks priority review and broad indication in metastatic melanoma for ground-breaking BRAF inhibitor.
You may also be interested in...
Speedy Approval Of Roche's Zelboraf Puts Pressure On Bristol's Yervoy
Personalized melanoma medicine vemurafenib set to sell for $9,400 a month, says Genentech. Genetic testing should be available right away.
Speedy Approval Of Roche's Zelboraf Puts Pressure On Bristol's Yervoy
Personalized melanoma medicine vemurafenib set to sell for $9,400 a month, says Genentech. Genetic testing should be available right away.
FDA Companion Dx Draft Guidance: Broad In Scope, Limited In Detail
FDA's draft guidance on the development of companion diagnostics for drug therapies, released July 12, delivers on a promise to publicly outline how it will address review of those products, but at only 12 pages, it has left some in industry longing for more insight.