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.

After highlighting oncology drugs pegged to make a splash next year with the help of Biomedtracker, Scrip takes a look at seven potential blockbusters across a range of therapeutic areas including neurology, dermatology and blood disorders slated for approval next year.

The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker