Did Boehringer Ingelheim withhold Pradaxa data from regulators?

23-07-2014 WSJ Pharmalot BlogComments (0)

Boehringer IngelheimHematologyPharmaceuticalPradaxa

Did Boehringer Ingelheim withhold important analyses of its Pradaxa blood thinner from regulators in the U.S. and Europe? An article by BMJ, the British Medical Journal, alleges the drug maker failed to share information with the FDA and the European Medicines Agency about the potential benefits of monitoring blood plasma levels and adjusting dosages to make sure Pradaxa works as safely and effectively as possible.

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