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NicOx announced it has received scientific advice on its proposed Phase III clinical plan for naproxcinod from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
Auxilium Pharmaceuticals has announced it is discontinuing the development of the current formulation of TestoFilm, its testosterone replacement transmucosal film product candidate for the treatment of hypogonadism.
The FDA announced it has approved Merck's Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DDP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar.
Roche has submitted a marketing authorization application to the European Medicines Agency (EMEA) for Herceptin (trastuzumab) as treatment for advanced HER2-positive and hormone-receptor-positive breast cancer.
Neuren Pharmaceuticals announced that its third lead candidate from its diketopiperazine (DKP) family, NNZ-2591, has reported positive preclinical effects of improved learning and memory after oral dosing.
Nema Research has initiated three Phase IV, multicenter, open-label clinical trials to evaluate the safety and efficacy of the synthetic cannabinoid nabilone, Cesamet, used as an adjuvant therapy for patients on stable analgesic regimens who still experience neuropathic pain associated with diabetic peripheral neuropathy, multiple sclerosis or chemotherapy.
TorreyPines Therapeutics has begun a Phase IIb trial of its lead product candidate, tezampanel, a novel pain compound in development for the treatment of acute migraine.