Drug for Excessive Sleepiness Shows Promise in Phase II Study

Thursday, November 8, 2007

Vanda Pharmaceuticals reported positive results from a phase II trial of VSF-173, an orally administered stimulant, for the treatment of excessive sleepiness. This randomized, double-blind, placebo-controlled trial enrolled  fifty-five subjects who received three doses of VSF-173 administered at 50 mg, 100 mg and 200 mg and placebo administered at 25 mg, 50 mg and 100 mg at the usual bedtime and at four hours after the first dose.

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Michael J. Fox Foundation Gets It and Gets It Done

Wednesday, November 7, 2007

The Michael J. Fox Foundation (MJFF) for Parkinson’s Research gets it. They have figured out just how many bottlenecks there are for getting good research out of academia and to the patient. And Michael J. Fox is willing to put its money where it is needed to move along the drug development process.

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Parexel Reports 26% First Quarter Revenue Increase

Monday, November 5, 2007

Boston, Mass.-based Parexel International reported service revenue increased 26.1% to $208.1 million for its first quarter of 2008 compared with $165.1 million during the same period of last year. The CRO ended the quarter with operating income of $16.5 million and margins of 7.9%. That compares with $11.3 million for the same period last year and a 6.9% margin. Net income for the quarter was $13.9 million compared with net income of $7 million.

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NEJM Takes Shots at CROs

Wednesday, October 31, 2007

A recent New England Journal of Medicine (NEJM) Perspective piece criticized the clinical trials industry for its reliance on contract research organizations (CROs). The piece describes the rapid growth in the CRO industry, questions the quality of research data it generates and cites various clinical trials that have shed some negative light on CRO-run studies.

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Centocor Psoriasis Drug Shows Impressive Results

Monday, October 29, 2007

Johnson & Johnson’s Centocor reported positive results from a phase III trial of CNTO1275 (ustekinumab) for the treatment of psoriasis. CNTO1275 is a monoclonal antibody (mAb) against the p40 subunit of interleukin 12 (IL-12) and IL-23. This randomized, double-blind, placebo-controlled study, dubbed PHOENIX 2, enrolled 1,230 subjects with chronic psoriasis.

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