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Galvus “Approvable” Letter Requests Additional Study In Renal Failure Patients

This article was originally published in The Pink Sheet Daily

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Executive Summary

Analysts indicate approval of the type 2 diabetes therapy could be delayed for a year or more.

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Takeda Files DPP-4 Inhibitor NDA, Poised To Best Bristol/AstraZeneca, Novartis In Race For Second To Market

NDA for alogliptin submitted Dec. 27, Takeda tells “The Pink Sheet” DAILY, giving the drug an expected Oct. 27, 2008, PDUFA date with standard review.

Takeda Files DPP-4 Inhibitor NDA, Poised To Best Bristol/AstraZeneca, Novartis In Race For Second To Market

Takeda submitted an NDA for its dipeptidyl peptidase-4 inhibitor alogliptin (SYR-322) for type 2 diabetes Dec. 27, potentially positioning the Japanese pharma to be second to market with a drug in the class

Takeda Files DPP-4 Inhibitor NDA, Poised To Best Bristol/AstraZeneca, Novartis In Race For Second To Market

NDA for alogliptin submitted Dec. 27, Takeda tells “The Pink Sheet” DAILY, giving the drug an expected Oct. 27, 2008, PDUFA date with standard review.

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