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Novartis has announced a three-month extension in the regulatory review period for its oral diabetes medicine Galvus (vildagliptin) after the company decided to submit newly available clinical data to the FDA.
AmpliMed reported final results from the Phase I trial of its lead drug candidate, Amplimexon (imexon for injection), in patients with advanced solid tumors.
Ovation Pharmaceuticals has announced positive results from its recent study to evaluate the safety and efficacy of clobazam in patients with Lennox-Gastaut syndrome (LGS), one of the most severe forms of childhood epilepsy.
Corcept Therapeutics has completed patient enrollment in Study 06, the third of three Phase III clinical trials in which Corlux (mifepristone) is being evaluated for treating the psychotic features of psychotic major depression.
Barr Pharmaceuticals announced that its subsidiary, Barr Laboratories, has received tentative approval from the FDA for its generic version of Eli Lilly's Zyprexa Zydis (Olanzapine) orally disintegrating tablets, 5, 10, 15 and 20 mg.
Sanofi-aventis announced that Acomplia (rimonabant), the first drug in a new class that targets multiple cardiometabolic risk factors, has received marketing authorization from Mexican health authorities.
Boehringer Ingelheim announced that the FDA has approved Mirapex (pramipexole dihydrochloride) tablets for the treatment of moderate to severe primary restless legs syndrome (RLS).
Callisto Pharmaceuticals has announced the initiation of a multicenter, open-label, Phase II clinical trial of Atiprimod to treat low- to intermediate-grade neuroendocrine carcinomas including advanced carcinoid cancers.