Quoted from http://www.reuters.com/article/2013/11/07/us-astrazeneca-brilinta-idUSBRE9A615X20131107
EU agency questions AstraZeneca over heart drug trial
By Ben Hirschler
LONDON Thu Nov 7, 2013 1:38pm EST
LONDON (Reuters) - Europe's medicines regulator has written to AstraZeneca asking it to provide more information about a U.S. probe into a clinical trial of the company's new heart drug Brilinta.
AstraZeneca is relying on Brilinta as a key driver of near-term sales and profit growth, and the unusual decision by the U.S. Department of Justice (DOJ) to launch an investigation has raised concerns about the product's future.
The London-based European Medicines Agency (EMA) said on Thursday that it contacted Britain's second biggest drugmaker earlier this week after the DOJ probe was disclosed by the company on October 31.
"The EMA takes seriously any information that may have an impact on the profile of a drug's benefits and risks," spokeswoman Monika Benstetter said in response to a Reuters inquiry.
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