Missouri's only abortion clinic will stay open after a state circuit court judge issued a preliminary injunction; the FDA overlooked red flags for esketamine after Janssen provided only limited data about the drug's safety and efficacy; opiod manufacturer Insys has filed for bankruptcy proctection after agreeing to pay $225 million to settle a federal investigation over its marketing of fentanyl.
State Circuit Court Judge Michael Stelzer issued a preliminary injunction yesterday that will temporarily prevent state officials from shutting down the only abortion clinic in Missouri, The New York Times reported. The clinic’s license wasn’t renewed after officials said that an audit had revealed serious health concerns; with the audit pending, the licene could not be renewed. Stelzer said the state’s Department of Health and Senior Services has until June 21 to make a decision over the license, but that the injunction would remain in effect until he issues another ruling.The FDA approved esketamine as a treatment for intractable depression after Janssen, the drug’s manufacturer, provided only modest evidence it worked from limited trials, Kaiser Health News reported. The company also provided no safety information about eskatamine beyond a period of 60 weeks. Janssen and the FDA dismissed red flags raised during clinical trials when 3 patients in the clinical program died by suicide.Opioid manufacturer Insys Therapeutics filed for bankruptcy protection yesterday after agreeing to pay $225 million to settle a federal investigation into its marketing practices for fentanyl, according to The New York Times. The company was accused of bribing physicians to prescribe its powerful painkiller and misleading insurers about patients’ need for the drug. Insys said it will continue operating while it creates a plan to pay its creditors under Chapter 11 of the federal bankruptcy code.