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Drugmakers submitting anonymous clinical data in applications to the EMA must keep up on technology advances that could put that data at risk for re-identification. Read More
The FDA’s regulations for drug promotions desperately need to be updated as they are unlikely to survive future court challenges, industry experts say. Read More
Newly confirmed FDA Commissioner Robert Califf sought to quell concerns about the FDA’s response to the opioid epidemic at a Senate hearing on the FDA’s $5.1 billion budget request for fiscal 2017. Read More
PhRMA is firing back at an Ohio citizen ballot initiative aiming to lower drug prices, claiming in a lawsuit that the activists involved failed to legally acquire a sufficient number of signatures to submit the petition to the General Assembly. Read More
Johnson & Johnson unit Janssen and AbbVie got the red light from the UK’s National Institute for Health and Care Excellence, which did not recommend the drug giants’ chronic lymphocytic leukemia drug Imbruvica. Read More