News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Errors, Misconduct, and an Alleged Cover-Up Attempt Delayed Pfizer Inc. (PFE), Bristol-Myers Squibb Company (BMY) Medicine



7/9/2013 8:33:32 AM

Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

Drugmakers have increasingly been turning to China for large clinical trials because they’re cheaper and there’s a bigger population of subjects to draw on. Now U.S. regulators have stepped in, questioning sloppy data and irregularities from the world’s most populous country. Bristol-Myers Squibb Co. (BMY) and Pfizer Inc.’s blood thinner Eliquis, approved in December, was stalled for nine months because of misconduct, errors and an alleged cover-up attempt at a Chinese trial site overseen by Bristol-Myers, according to documents posted by the U.S. Food and Drug Administration. The delay came after the company told the FDA that patients got the wrong medicine, records were secretly changed and “serious adverse events” went unreported, the documents show.

Help employers find you! Check out all the jobs and post your resume.

Read at Bloomberg
Read at Seeking Alpha
Read at ChinaBio Today


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES