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ICER found that in combination with aspirin, Xarelto reduced the risk of cardiovascular death, stroke or heart attack in patients with stable cardiovascular disease. Read More
Eleven drugmakers agreed to pay the state of Illinois $242 million to settle a 2005 lawsuit over the wholesale prices of their prescription drugs. Read More
The FDA outlined new electronic submission requirements for sponsors of investigational new drug applications (INDs) that apply to certain IND safety reports, in a draft guidance released on Tuesday. Read More
An FDA advisory committee voted on Tuesday to support withdrawal of FDA approval for AMAG Pharmaceuticals’ preterm birth injection Makena (hydroxyprogesterone caproate). Read More
“The incredible speed of this approval underscores our shared sense of urgency with the FDA and the CF community,” a Vertex spokesperson said. Read More
Novartis hit three generic drugmakers with a lawsuit in a Delaware federal court for patent infringement over its heart-failure drug Entresto (sacubitril/valsartan). Read More
Allergan announced that its subsidiary Forest Laboratories will pay $750 million to direct purchasers to settle allegations of anticompetitive behavior over the Alzheimer’s drug Namenda (memantine). Read More