Global observational study is assessing real-world experience with Pradaxa and other anticoagulants in patients with newly diagnosed atrial fibrillation and at risk of stroke. Results are due in 2020.
Boehringer Ingelheim GMBH is gearing up to collect real-world, comparative data pitting its anticoagulant Pradaxa (dabigatran) against other treatments for stroke prevention in atrial fibrillation, including Johnson & Johnson/Bayer AG’s competing Xarelto (rivaroxaban) and long-time standard of care warfarin, in a massive global trial.
Boehringer’s GLORIA-AF registry program will look at long-term use of antithrombotic treatments for reducing risk of stroke in 56,000 patients...
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
