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The FDA’s cancer drug advisory committee voted Tuesday on two new treatments from Daiichi Sankyo—backing one while giving the thumbs down for the other. Read More
AbbVie has settled its lawsuit with Boehringer Ingelheim, the last domino to fall in an all-out patent war that will protect AbbVie’s mega-blockbuster Humira until 2023. Read More
Merck urged the FDA to look into potential safety concerns as the agency seeks to widen patient eligibility criteria for oncology drug trials of HIV, hepatitis B and hepatitis C patients. Read More
Acting FDA Commissioner Ned Sharpless said the agency is inching closer to bringing cheaper insulins to the market but that critical regulatory questions remain. Read More
The guidance draws a line between information about patients’ health status or healthcare delivery “routinely collected from a variety of sources” and clinical evidence for a drug from analysis of real-world data. Read More