Cubist Tedizolid Advisory Cmte. Review Will Gauge FDA’s Mood On Antibiotic “Breakpoints”
This article was originally published in The Pink Sheet Daily
Cubist’s second-generation oxazolidineone is set for an FDA advisory committee review in March.
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Anti-Infective Drugs Advisory Committee will meet Oct. 17 to discuss whether and when it is appropriate to base susceptibility test interpretive criteria on the highest or lowest approved dose of a drug, or whether labeling should reflect breakpoints specific to each approved dosing regimen and indication.
Tedizolid, a next-generation antibiotic from the same class as Pfizer’s Zyvox, has met all complicated skin infection endpoints for both a U.S. and European filing, and Trius plans submissions in second half 2013 and first half 2014, respectively. European partnering talks, meanwhile, have gained new intensity.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.