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

Records Show Boehringer Ingelheim Corporation Did Not Disclose Pradaxa Analysis To FDA


2/26/2014 7:17:11 AM

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

Boehringer Ingelheim GmbH didn’t disclose a data analysis to U.S. regulators that indicated the blood-thinner Pradaxa may have caused more fatal bleeding after it was cleared for sale than the drug did in a study used to win approval, unsealed court filings show. Boehringer gave U.S. regulators one analysis of data gathered after the drug’s October 2010 approval that showed the number of people who died from bleeding was less than expected, according to internal documents made public in lawsuits over the product. The company didn’t share a second analysis showing a higher death rate, the documents show.

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

Read at Bloomberg


comments powered by Disqus
Bloomberg
   

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