FDA To Continue Its Review of Requests for Release of Clinical Hold on alvimopan (Entereg(R)) (Business Wire via Yahoo! Finance)
EXTON, Pa.----Adolor Corporation announced today that the U. S. Food and Drug Administration has informed Adolor and GlaxoSmithKline that it needs additional time to complete its review of the submissions for the release of the clinical hold on alvimopan , and as a result, the clinical hold for all alvimopan Investigational New Drug Applications remains in effect.

FDA Receiving Many More Serious Adverse Events Reports (Medical News Today)
Between 1998 and 2005 the number of reports about serious adverse events sent to the Food and Drug Administration (FDA) has more than doubled; total deaths linked to adverse drug events have also more than doubled, according to an article in Archives of Internal Medicine (JAMA/Archives). [click link for full article]

Setback to Dr Reddy's in US case (Indian Express via Yahoo! India News)
In what could be termed as a setback to the Indian drug major, Dr Reddy's Labs has reached at an out-of-court settlement with Teva Pharmaceuticals in patent litigation regarding the sales of blockbuster anti-depressant drug, Zoloft. Under the agreement, Dr Reddy's will not sell generic Zoloft in the US other than to Teva. Also, Dr Reddy's will provide Teva with 30-days advance notice of any ...