AstraZeneca Discloses US Investigation Into Heart Drug Trial

Law360, New York (October 31, 2013, 5:20 PM EDT) -- UK pharmaceutical giant AstraZeneca PLC disclosed Thursday that the U.S. Department of Justice had opened an investigation into a clinical trial that was the basis for regulatory approval of its new heart drug Brilinta in the U.S., Europe and other markets.

The Plato trial was conducted on 18,000 patients, and results from the study were first reported at a medical meeting in 2009. The U.S. Food and Drug Administration approved Brilinta, a blood thinner, to treat acute coronary symptoms in July 2011, saying that in clinical...
To view the full article, register now.