Government alleges Omnicare and its parent CVS Health filled thousands of invalid prescriptions to elderly and disabled individuals; suit follows nine settlements and two corporate integrity agreements since 2006.

Label offers little differentiation from Tecfidera, but head-to-head trial with custom-designed patient-reported outcome could make case for gastrointestinal tolerability advantage.

The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.

This week's roundup includes CEO appointments by Eton Pharmaceuticals, the Biotechnology Innovation Organization and Hikma, in addition to various other high-level appointments by Astellas, Akili Interactive Labs and Oxford BioDynamics.