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The agency’s existing technical standards are better-suited to clinical trial data, and mapping RWD to these formats will result in the loss of granularity and introduce new opportunities for human error, pharmaceutical industry representatives and data companies say in comments on a draft guidance.
Teva has settled with the state of Rhode Island on opioid-related claims and is set to pay the state $21m in cash and provide $78.5m worth of Narcan and Suboxone. The settlement was reached just as Rhode Island was preparing to take Teva to trial.
J&J and distributors have enough participation from states and subdivisions to move forward with $26bn settlement. The deal, the second largest in US history, may provide a framework for other companies to reach similar agreements. Jury trials remain pending in several states.
New York jury finds that Teva and distributor Anda violated state’s public nuisance law in their marketing and distribution of opioids. Such claims had been rejected by two previous courts and the verdict in this case shows the challenges companies face in ongoing litigation.
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