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The FDA found substantial sterility problems on a visit to Kansas-based ARJ Infusion Services, makers of in-home intravenous medications for adults and children with rare and chronic conditions. Read More
The U.S. District Court for the Eastern District of Tennessee entered a permanent injunction against Crown Laboratories of Johnson City and its CEO, Jeffrey Bedard, after accusations of distributing unapproved and misbranded drugs. The company’s products, which include urea creams and lotions intended to treat dermatological problems, were sold and distributed without FDA approval or a sufficient demonstration of their safety and efficacy, according to the complaint the Justice Department filed in March at the request of the FDA. Read More
An FDA vaccine advisory panel voted 12-to-1 last Friday to recommend approval of Dynavax’s Hepislav-B in adults for the prevention of hepatitis B. Read More
Pharmaceutical and medical device companies will not get tax breaks after the Republican effort to repeal the Affordable Care Act came to a halt in the Senate early Friday morning, with nays from Sens. Lisa Murkowski (R-Alaska), Susan Collins (R-Maine) and John McCain (R-Ariz.). Read More