March 16, 2019 / 12:07 AM / 7 days ago

Vanda loses bid to proceed with drug trial while FDA reconsiders hold

A federal judge ruled on Thursday that Vanda Pharmaceuticals Inc could not proceed with a human clinical trial for its gastrointestinal drug tradipitant while the U.S. Food and Drug Administration weighs requiring months of additional animal toxicity testing.

Vanda sued the FDA on Feb. 5 in U.S. District Court in Washington, D.C., after the agency blocked it from conducting a human study of tradipitant lasting more than 12 weeks without first doing additional animal studies on long-term safety.

To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2ULvvik

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