Glenmark gets US nod for drug trials.
Economic Times (New Delhi, India), October, 2007
Oct. 30--MUMBAI, India -- Ending a long wait for Glenmark Pharmaceuticals, the US Food and Drug Administration (FDA) finally gave its nod to the Indian drugmaker to resume clinical trials of its asthma and chronic obstructive pulmonary disorder (COPD) experimental drug.
The USFDA had last year asked Forest Laboratories, to which Glenmark licensed out its drug in 2004, to conduct additional pre-clinical studies on animals, before resuming trials on patients, putting Glenmark's $30 million milestone on hold.
"We have completed the additional studies required by the FDA, and the data has been submitted and approved, giving us the go-ahead to resume trials on patients," said CEO Glenn Saldanha. "We have also submitted additional questions to the FDA to...
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