This article was originally published in The Gray Sheet
Epigenomics, RainDance, and Brightree name new leadership, and more personnel news from around the industry.
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Agreement with UN-affiliated body set to expand global availability in lower income countries of Japanese firm’s protease inhibitor, which has faced approval road bumps at home but now looks set to move forward on positive new Phase III data.
It's not clear that the proposed revisions and additions to the Centers for Medicare and Medicaid Services’ existing coverage with evidence development study design requirements would address what some experts view as a program failure – the fact that sponsors of the vast majority of technologies subject to CED have not generated the data CMS is looking for.
Teva’s carve-out fight with GSK over generic Coreg will see the Solicitor General weigh in. Amgen and Juno’s patent petitions remain pending, and the high court stays a Federal Circuit decision invalidating Novartis’ Gilenya patent.