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A panel advising U.S. drug regulators said Eli Lilly and Co.
LLY,
and its Chinese partner should conduct more studies of a proposed new lung-cancer drug before approval, citing concerns about the medicine’s testing in China.
The advisers voted 14 to 1 on Thursday to recommend the additional testing after Food and Drug Administration officials said a Chinese study of the drug had significant shortcomings and its results weren’t applicable to U.S. patients.
The setback for Indianapolis-based Lilly and Chinese biotech company Innovent Biologics Inc.
1801,
is a sign of a tougher U.S. stance on drugs that are tested only or predominantly in China.
FDA officials have recently cited concerns about the quality of drug studies conducted largely in China and whether the results can apply to patients in the U.S.
An expanded version of this story appears on WSJ.com.
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