Thursday, October 31, 2013

U.S. authorities quiz AstraZeneca over Brilinta clinical trial

AstraZeneca is being investigated by U.S. authorities over a major clinical trial that was used to win marketing approval for its new heart drug Brilinta. The British drugmaker said on Thursday it had received a civil investigative demand from the U.S. Department of Justice seeking documents and information regarding the so-called PLATO study. AstraZeneca, which highlighted the investigation in its quarterly results statement, gave no further details but said it intended to cooperate with the inquiry. A key challenge for Brilinta is the fact that U.S. doctors tend to use high-dose aspirin for cardiovascular patients and clinical trials suggest AstraZeneca's new drug does not work as well in this setting.



via Health News Headlines - Yahoo! News http://news.yahoo.com/u-authorities-quiz-astrazeneca-over-brilinta-clinical-trial-095327330--finance.html

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