Johnson & Johnson/Bayer's Xarelto (rivaroxaban) received FDA approval for stroke prevention in atrial fibrillation (SPAF). It's the second novel anticoagulant to gain US marketing approval in the past 13 months for SPAF, expanding its label from venous thromboembolism (VTE) prophylaxis. It will battle Boehringer Ingelheim's oral anticoagulant Pradaxa for market share in the Afib setting and, if approved, Bristol-Myers Squibb/Pfizer's Eliquis, a SPAF favorite. As expected, Xarelto's label does not include a superior-to-warfarin claim but does emphasize regulators' uncertainty regarding Xarelto's relative merits and has a black-box warning against discontinuing without discussing with a physician.
Siemens Healthcare acquired MobileMD, maker of cloud-based technology which helps hospitals “data enable” physician practices and coordinate care. Terms of the deal, which closed Friday, were not disclosed. MobileMD's health-information exchange tools are in use by more than 110 hospitals and more than 2,000 physician practices. MobileMD helps hospitals connect providers to lab or imaging results and discharge notes and includes online ordering, referrals and scheduling.