We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Clearside Biomedical received a complete response letter (CRL) from the FDA for its macular edema drug candidate over the need for additional stability data. 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
A generic drug manufacturer in the Bahamas drew a warning letter from the FDA and was placed on an import alert for cGMP violations at its Freeport City facility, including inadequate validations and testing. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) endorsed seven drugs for approval at its October meeting, including a biosimilar of Amgen’s Neulasta (pegfilgrastim). Read More