Johns Hopkins doctor challenges approval of AZN's Brilinta

|By:, SA News Editor

An adjunct medical professor at Johns Hopkins Hospital has challenged the FDA's 2011 approval of AstraZeneca's anticlotting drug Brilinta, the WSJ reports.

Using the federal False Claims Act, Victor Serebruany has filed a complaint arguing that data was manipulated in a trial which showed that the medicine saved lives and cut heart attacks. The U.S. attorney's office in Washington DC is investigating the conduct of the trial.

Separately, AstraZeneca (AZN) has completed the acquisition of Bristol-Myers Squibb's (BMY) holding in the companies' diabetes joint venture for an initial $2.7B and as much as $1.65B in additional payments, as well as royalties on sales. (PR)