Cephalon, Inc. (Nasdaq: CEPH) announced that it has received an approvable letter, together with draft labeling, from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for NUVIGIL(TM) (armodafinil) Tablets [C-IV] for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).
Theravance, Inc. (NASDAQ: THRX) announced the results of two studies in an ongoing Phase 2b clinical program to assess the efficacy and safety of the investigational bronchodilators GSK642444 (‘444) and GSK159797 (‘797), the lead long-acting Beta2 agonist (LABA) compounds in the Beyond Advair collaboration with GlaxoSmithKline (GSK).
Combining two different types of treatment for migraine results in better symptom relief than taking either one of the medications, according to a study in the April 4 issue of JAMA.
Women who initiate hormone therapy closer to menopause tend to have a reduced risk of coronary heart disease compared to women who begin treatment further from menopause, but researchers did not find this reduced risk was statistically significant, according to a study in the April 4 issue of JAMA.
The largest retrospective, observational study comparing two osteoporosis therapies on the basis of fracture reduction was presented today at the Seventh European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO) in Porto, Portugal.
Novartis is complying with a request from the Food and Drug Administration (FDA) to suspend US marketing and sales of Zelnorm (tegaserod maleate), a treatment for irritable bowel syndrome (IBS) with constipation and chronic constipation.
The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug.
Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), and Lundbeck A/S presented clinical study results on bifeprunox at an international medical congress this week.
Soldiers exposed to the deafening din of battle have little defense against hearing loss, and are often reluctant to wear protective gear like ear plugs that could make them less able to react to danger. But what if a nutritious daily “candy bar” could prevent much of that potential damage to their hearing?
For depressed people with bipolar disorder who are taking a mood stabilizer, adding an antidepressant medication is no more effective than a placebo (sugar pill), according to results published online on March 28, 2007 in the New England Journal of Medicine.