Bayer and Johnson & Johnson's anticoagulant Xarelto, or rivaroxaban, should be considered for preventive use in patients with acute coronary syndrome, according to a recommendation from the EU's Committee for Medicinal Products for Human Use. The panel's opinion comes weeks after the FDA sought additional information instead of approving a similar indication in the U.S.
Bayer and Johnson & Johnson are initiating two late-stage trials of the anticoagulant rivaroxaban after failing to get expanded FDA approval for the prevention of cardiovascular events in patients with acute coronary syndrome. One trial will involve individuals with chronic heart failure and significant coronary artery disease. The other will include patients with nonvalvular atrial fibrillation.
Health Canada issued a public advisory about the possibility of serious skin reactions with the hepatitis C treatment Incivek from Vertex Pharmaceuticals. The move comes two months after the FDA released a similar warning.
Scientists at Saarland University in Germany used high-speed cameras to find that blood plasma can behave like a solid at small scales, according to a study in the journal Physical Review Letters. Thanks to long molecules contained in plasma, the solution has properties that are both viscous and elastic, allowing an elongated flow through tight capillaries or past clots. Researchers said their work could lead to improved models of blood flow and help advance the development of artificial blood.
The FDA has not approved the anticoagulant rivaroxaban as a treatment for acute coronary syndrome. Johnson & Johnson is assessing the FDA's complete-response letter and will work with the agency to answer questions.