Clotbusting On The Clock: New Brands Must Establish Themselves Before Improved Plavix Diagnostics Do
FDA's three-month postponement of a decision on AstraZeneca PLC’s NDA for Brilinta (ticagrelor) may signal more trouble for the long-term viability of the product rather than any concern about its actual approvability.
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AstraZeneca's antiplatelet agent Brilique/Brilinta receives its first approval, but pricing negotiations will delay launch in most countries.
Study results don't prove clinical benefit for point-of-care testing, but trial may not have been sufficiently powered to show a difference.
Europe's CHMP recommends ticagrelor for patients with acute coronary syndromes, while FDA still grapples with lack of effect in North American patients.