Proposed current good manufacturing practices requirements for positron emission tomography drugs will reflect the “unique characteristics” of radiopharmaceuticals, HHS says. The rule would build upon a draft guidance and preliminary draft proposed cGMP rule, both issued in 2002.

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.

With an unrestricted label and once-daily dosing, rivaroxaban will do battle with Boehringer-Ingelheim's dabigatran, which is dosed twice a day but can claim superior efficacy to warfarin in the atrial fibrillation population.