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“We know that the migraine community is keenly interested in additional treatment options,” said Nick Kozauer, acting deputy director of CDER’s Division of Neurology Products. Read More
In its latest cost-benefit analysis, the Institute for Clinical and Economic Review (ICER) found that Janssen’s Xarelto (rivaroxaban) and Amarin Pharma’s Vascepa (icosapent ethyl) are cost-effective treatments for cardiovascular disease — provided not all eligible patients are treated. Read More
In a letter to acting FDA Commissioner Ned Sharpless, three U.S. lawmakers demanded updates on Takeda Pharmaceuticals’ recall of Natpara (parathyroid hormone), an injection used to treat a rare parathyroid disorder. Read More
In a 3:00 p.m. EST teleconference on Monday, the attorneys general of Pennsylvania, North Carolina, and Tennessee confirmed they had reached a $48 billion settlement for thousands of opioid lawsuits with drugmakers Teva and Johnson & Johnson, as well as distributors McKesson, Cardinal Health and AmerisourceBergen. Read More
The FDA offers its latest advice on what drug sponsors should include when submitting drug master files (DMFs) in a draft guidance released on Friday. Read More
The federal judge at the center of the first opioid bellwether trial met with key litigants on Friday to hammer out a settlement, but the eleventh-hour effort stalled. Read More