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WASHINGTON, March 25, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA) today announced that the company held a pre-NDA meeting with the Division of Neurology Products of the U.S. Food and Drug Administration (FDA) to discuss the regulatory path for filing a New Drug Application (NDA) for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder (Non-24). Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally...

WASHINGTON, Jan. 31, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) today announced top-line results of the Phase IIb/III clinical study (MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and safety of tasimelteon as a monotherapy in the treatment of patients with MDD. The clinical study did not meet the primary endpoint of change from baseline in the Hamilton Depression Scale (HAMD-17) after 8 weeks of treatment as compared to placebo. Both...

KING OF PRUSSIA, Pa., Jan. 6 /PRNewswire/ -- Prism Pharmaceuticals, Inc. announced today that Dr. Warren D. Cooper, President and Chief Executive Officer, will present at the 27th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2009 at 7:30 a.m. (Pacific Time) or 10:30 a.m. (Eastern Time). The conference will be held at the Westin St. Francis Hotel in San Francisco, California. Dr. Cooper will present corporate strategy and highlight the recent FDA approval of the...

By Carrio, M L Fortia, C; Javierre, C; Rodriguez, D; Farrero, E; Ricart, A; Castells, E; Ventura, J L Aim. It was believed that amiodarone-related adverse respiratory effects were found only when receiving amiodarone on a long-term basis, but several reports seem to contradict this hypothesis. The aim of this study was to evaluate, in an intensive care unit (ICU), the possibility of acute respiratory toxicity induced by short-term amiodarone administration following cardiac surgery. Methods....

Knight Ridder Newspapers WASHINGTON - A highly toxic heart drug continues to be prescribed to millions of patients nationwide without the detailed consumer warnings promised by the U.S. Food and Drug Administration more than a year ago. Each bottle of the drug, amiodarone, is supposed to include a new advisory that warns of its many risks and symptoms of fatal side effects and explains how the medication is supposed to be used. But the advisory, planned since October 2003, remains in draft...