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In blow to Jazz Pharma, US panel undoes clinical trial limits placed on Avadel

By Melissa Ritti ( May 7, 2025, 14:05 GMT | Insight) -- A Delaware federal judge went too far when enjoining Avadel CNS Pharmaceuticals from seeking regulatory approval of its sleep disorder drug Lumryz for the treatment of idiopathic hypersomnia, the US Court of Appeals for the Federal Circuit ruled. The precedential ruling paves the way for Avadel clinical trials to continue but leaves unanswered the question of whether a common clinical trial practice falls within the Hatch-Waxman Act’s safe harbor.An effort by Jazz Pharmaceuticals and Jazz Pharmaceuticals Ireland to thwart Avadel CNS Pharmaceuticals from encroaching on their market exclusivity for the treatment of a rare sleep disorder has hit a major snag....

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