Impax/GSK's Extended-Release Parkinson's Treatment IPX066 Aces Third Phase III Trial
This article was originally published in The Pink Sheet Daily
Impax plans Q4 FDA submission, while GSK will approach European regulators in 2012.
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FDA dealt Impax Pharmaceuticals a “complete response” for its extended-release carbidopa/levodopa therapy for spasms suffered by Parkinson’s disease patients, rejecting the drug combo based on unresolved manufacturing issues at the firm’s Hayward, Calif., plant, though Impax has said it will manufacture the product, now called Rytary, exclusively at its Taiwan facility.
With no Parkinson's candidates in its pipeline, the pharma pays $11.5 million upfront for ex-U.S. rights to Phase III compound.
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.