Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online meetings, and phone calls has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction by brewing cups of stimulation. Our choice today is maple bourbon, a double shot for the needy neurons. Meanwhile, here are a few items of interest to start you on your journey, which we hope is meaningful and productive. Best of luck, and do keep in touch. …
George Tidmarsh, the U.S. Food and Drug Administration’s top regulator of medicines, has resigned after being accused of using his regulatory authority to inflict financial harm on a former business associate, STAT reports. FDA Commissioner Marty Makary placed Tidmarsh on administrative leave after opening an investigation into his conduct in recent days based on a complaint filed against Tidmarsh by Kevin Tang, a health care investor and business owner. One of Tang’s affiliated companies, Aurinia Pharmaceuticals, filed a lawsuit against Tidmarsh on Sunday, accusing him of a “longstanding personal vendetta against Kevin Tang.” In an interview with STAT, Tidmarsh confirmed he was placed on leave from his role as the director of the FDA’s Center for Drug Evaluation and Research. Makary informed him about Tang’s complaint on Friday, but Tidmarsh did not find out he had been placed on leave until he was locked out of his agency email account on Saturday. Tidmarsh denies any wrongdoing.
A U.S. judge ruled that 36 drugmakers and executives must face nearly all claims in an antitrust lawsuit brought by most U.S. states, accusing them of conspiring to fix prices of 80 generic medicines, Reuters writes. Chief Judge Michael Shea of the federal district court in Connecticut rejected claims that 45 states, the District of Columbia, and four U.S. territories waited an unreasonably long time to pursue federal antitrust claims, and missed formal deadlines to file similar claims under state laws. Led by Connecticut, the states accused drugmakers of conspiring to raise prices, limit competition, and allocate customers for drugs, primarily for skin ailments, between 2009 and 2016. In his 130-page decision, Shea said the defendants failed to show that the states “lacked diligence” in pursuing their case, citing evidence that the defendants pursued “affirmative acts” to conceal their alleged collusion.
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STAT Pharma: The science and business of new drug development
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