FDA’s Approach To Combination Pediatric Therapies: Monotherapy Comes First
This article was originally published in The Pink Sheet Daily
Limited data limits the ability of companies to move to combination strategies, members of an advisory panel cautioned during a review of two checkpoint inhibitors.
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In a final guidance on co-development of two or more investigational new drugs for use in combination, FDA lays out general principles for IND and marketing application submissions, a topic on which the agency essentially punted in a December 2010 draft document.
Phase I data for immune checkpoint molecules in melanoma from Bristol, Roche and Merck were a major highlight of the ASCO 2013 annual meeting. Considering potential application in many cancers regardless of genetic mutations, some analysts are predicting billions in future sales.
Pink Sheet Podcast: Another Coronavirus Stimulus Bill, Remdesivir’s Brief Orphan Status, Teva Sues Over Copaxone Regulation
Pink Sheet editor and reporters discuss the effects of the latest coronavirus stimulus package on pharma, Gilead’s request for rescission of an orphan designation, and Teva’s suit over Copaxone regulation.