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Medivation announced that its proprietary drug Dimebon met all five efficacy endpoints in a six-month randomized, double-blinded, placebo-controlled Phase II clinical study of 183 patients with mild to moderate Alzheimer's disease conducted at 11 sites in Russia.
Nucryst Pharmaceuticals announced preliminary results from a Phase II clinical trial examining the safety and efficacy of NPI 32101 topical cream in children and adolescents with atopic dermatitis showed no statistical efficacy.
Kos Pharmaceuticals has announced preliminary results from two Phase III trials of Icatibant, FAST-1 and FAST-2, for the subcutaneous treatment of hereditary angioedema (HAE), a genetic disease.
Axcan Pharma announced that results of a North American Phase III clinical study showed that Itopride, a drug developed for the treatment of functional dyspepsia, did not meet its primary endpoints.
Epix Pharmaceuticals announced that the results from its Phase III trial of PRX-00023, a long-acting 5-HT1A agonist, show that overall PRX-00023 did not achieve a statistically significant improvement over placebo for the primary endpoint.
Join FDAnews Tuesday, Oct. 10, for "Postmarketing Trials On Time and Under Budget: How to Maximize Your Investigator Investment." In this 90-minute interactive audioconference, Dr. Hugo Stephenson, author and president of strategic research and safety at Quintiles, the world's largest provider of contract research services, gives you practical study design tactics and user-friendly forms that enable you to motivate study investigators. On Oct. 11, join FDAnews for "Spreadsheet Validation Made Easy: Tools and Techniques to Meet FDA Requirements." In this 90-minute audioconference with Q&A session, top validation expert David Harrison shows you how to use a risk-based approach to achieve maximum compliance with minimum time, trouble and expense.
Glenmark Pharmaceuticals has received tentative approval from the FDA for its abbreviated new drug application for ondansetron hydrochloride tablets, 4, 8 and 24 mg.