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UK-based Egalet has signed a licensing agreement with Shionogi to develop and market oral abuse-deterrent hydrocodone opioid products, with Shionogi footing the bill for all development costs and holding on to global marketing rights. Read More
Sitoa Global and the University of California San Francisco have signed a letter of intent to negotiate an option agreement for the license of a stereotactic device to deliver stem cells directly into the brain. Read More
The FDA has extended its review of Mallinckrodt’s NDA for its investigational painkiller Xartemis XR by 90 days, saying it needs more time to review the drug’s proposed labeling. Read More
A durable medical equipment provider pleaded guilty Nov. 21 to one count of healthcare fraud in the U.S. District Court for the Southern District of Florida in a scheme the Justice Department says defrauded Medicare of more than $11 million. Read More
EU regulators on Friday assured Ariad that its leukemia drug and sole product Iclusig can continue to be sold throughout Europe for its approved indications. Read More
Human Design Medical Thursday launched its “lighter, smaller, quieter” Z1 continuous positive airway pressure device for sleep apnea patients looking for more mobile nighttime breathing support. Read More
The Sorin Group has sent a Dear Doctor letter to physicians after Hong Kong’s Department of Health received eight reports of faulty elective replacement indicators used to program the settings on three of the company’s pacemakers. Read More
The FDA has granted “regular” approval for Pfizer’s lung cancer drug Xalkori after conditionally approving it in August 2011 under the agency’s accelerated approval program. Read More