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The FDA cited a Dallas home infusion therapy pharmacy for failure to maintain sterile conditions for drugmaking after inspectors found dead insects in a cleanroom and in refrigerators used to store ingredients and finished products. Read More
A Chinese maker of pain-relief balms and ointments falsified results of tests on its products and deflected FDA inspectors seeking to examine its laboratory, the FDA said in a warning letter. Read More
A federal judge ruled Purdue Pharma must face most of the claims in a lawsuit filed against the drugmaker by a Washington city earlier this year. Read More
The PTO’s Patent Trial and Appeals Board invalidated Aventis Pharma’s patent for the chemotherapy drug Jevtana (cabazitaxel), following a challenge from Mylan. Read More
PhRMA now supports limiting opioid prescriptions for acute pain to a seven-day supply — down from the traditional 30 — saying excess pills can end up falling into the wrong hands. Read More
A New York City pharmacy that produces drugs as part of the multibillion-dollar Magellan Health healthcare management corporation was cited in an FDA warning letter for failure to maintain sterile processing procedures. Read More
A Pennsylvania federal judge dismissed a class-action lawsuit against more than 10 drugmakers that accused them of misrepresenting facts to inflate generic drug prices. Read More
The European Medicines Agency stands to lose nearly one-fifth of its staff when it leaves London, no matter which city in the European Union is selected for its new headquarters, a survey of the EMA workforce showed. Read More
The FDA finalized guidance on its process for assigning applications to a specific regulatory center, hoping to answer frequently asked questions from industry sponsors regarding whether their product will be classified as a drug or as a device. Read More