Wednesday, March 23, 2011

FDA orders more trials on PPD diabetes drug - Triangle Business Journal:

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Wilmington-based PPD (Nasdaq: PPDI) is partnering with Takeds on thedrug alogliptin, which is being developed for the treatmengt of type 2 diabetes. Approvapl was expected in a milestone that would have triggerefa $25 million payment from Takedqa to PPD. But in March, PPD said it did not expec t to receive that paymentthis year. The companiews announced at the time that the FDA plannedr to continue evaluating alogliptin under new safety guidelinesa for diabetes drugs issued in December 2008. The FDA said it would review the drug unde those standards even though alogliptin was submitted beforse the new guidelines wentinto effect.
On the companies announced that Takeda has receiveds official word that the FDA will required an additional cardiovascular safety study on the PPD employsnearly 2,000 people in the Raleigh-Durham

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