Beginning Next Week: InsideCounsel will become part of Corporate Counsel. Bringing these two industry-leading websites together will now give you comprehensive coverage of the full spectrum of issues affecting today's General Counsel at companies of all sizes. You will continue to receive expert analysis on key issues including corporate litigation, labor developments, tech initiatives and intellectual property, as well as Women, Influence & Power in Law (WIPL) professional development content. Plus we'll be serving all ALM legal publications from one interconnected platform, powered by, giving you easy access to additional relevant content from other InsideCounsel sister publications.

To prevent a disruption in service, you will be automatically redirected to the new site next week. Thank you for being a valued InsideCounsel reader!


DOJ closes probe into clinical trials for AstraZeneca’s Brilinta drug

The DOJ had been investigating whether the company manipulated the number of deaths from an opposing drug

When the U.S. Department of Justice (DOJ) opens a probe into a specific drug — especially one as potentially lucrative as AstraZeneca’s Brilinta —pharmaceutical companies are often left scrambling. But AstraZeneca is breathing a huge sigh of relief today, as the DOJ has cleared the company of any wrongdoing in conducting clinical trials.

The DOJ announced that it was closing a probe into Brilinta that it had opened in October 2013. The department had been trying to determine whether a major clinical trial called PLATO had been fairly conducted.

PLATO was a study consisting of 18,624 patients in 43 countries, comparing the effects of Brilinta to clopidrogel (marketed as Plavix by Sanofi SA before it went off patent in 2012). According to the study, patients taking Brilinta plus aspirin suffered fewer instances of heart attack, stroke or death from vascular causes.

However, Dr. Victor Serebruany, an adjunct medical professor at Johns Hopkins Hospital, wrote in a complaint to the U.S. district court in the District of Columbia that he believed the numbers in the study had been manipulated. In particular, he asked the DOJ to probe the number of deaths in the group taking clopidrogel, which he believed to be artificially high.



State AGs reach settlement with Wyeth Pharma over misleading marketing practices

Two Houston attorneys will get $21.8M in fees, twice the recommendation for a case involving Pfizer

The patent war over hepatitis C drugs



In clearing the PLATO study, the DOJ has preserved a key drug in AstraZeneca’s arsenal. One of the five “platforms” that the company is using to drive sales growth, AstraZeneca used Brilinta as just one example of why it was rejecting Pfizer’s proposed takeover bid from early 2014.

“We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefits Brilinta offers to patients around the world,” AstraZeneca CEO Pascal Soriot said in a statement to the Wall Street Journal.

Sales of Brilinta came in at $114 million for the second quarter of 2014. However, the company is hoping to expand the drug’s reach, conducting another study of 80,000 patients to see whether the drug can be used for patients with a specific type of heart attack or stroke.

Assistant Editor

author image

Zach Warren

Zach Warren is Assistant Editor of InsideCounsel magazine, where he oversees online content submissions and administers InsideCounsel's enewsletters. Zach specializes in new media and multimedia...

Bio and more articles

Join the Conversation

Advertisement. Closing in 15 seconds.