Scott Gottlieb avoided explicit written commitments to recusing himself from decisions involving nearly two dozen companies named in a senator’s questions. Source: Drug Industry Daily

Apotex has called on the FDA to require testing on the intended patient population before approving biosimilars. Source: Drug Industry Daily

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…

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. Source: Drug Industry Daily

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…

The European Medicines Agency Committee for Medicinal Products for Human Use recommended 11 medicines for approval, including four orphan drugs and three biosimilars. Source: Drug Industry Daily

The FDA approved Renflexis, a biosimilar of Remicade, in several indications including rheumatoid arthritis, plaque psoriasis and Crohn’s disease. Source: Drug Industry Daily

The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including developing a model for the agency’s future, post-Brexit. Source: Drug…

An FDA memo outlining restrictions on communications over unapproved uses could restrict the flow of important information, and conflict with a company’s freedom of speech, say drugmakers and industry groups.…