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Scott Gottlieb avoided explicit written commitments to recusing himself from decisions involving nearly two dozen companies named in a senator’s questions. Read More
In a lawsuit filed Monday, Sanofi says Mylan’s anticompetitive business practices blocked its EpiPen competitor, the Auvi-Q, from gaining a foothold in the epinephrine auto-injector market, resulting in hundreds of millions in lost sales. Read More
The FDA has officially notified Texas and Arizona that they must destroy their supplies of execution drugs on the grounds that they were illegally obtained. Read More
For the development of generic versions of naloxone, an emergency nasal spray treatment for opioid overdoses, the FDA said it will allow sponsors to demonstrate bioequivalence using solely in vitro performance tests — as long as the generic is qualitatively the same as the reference product. Read More
The European Medicines Agency Committee for Medicinal Products for Human Use recommended 11 medicines for approval, including four orphan drugs and three biosimilars. Read More
The FDA approved Renflexis, a biosimilar of Remicade, in several indications including rheumatoid arthritis, plaque psoriasis and Crohn’s disease. Read More