GSK and XenoPort resubmit NDA for Solzira in restless legs syndrome
Scientists have uncovered vital clues about how to treat serious bowel disorders by studying the behaviour of cells in the colon. Researchers at the University of Edinburgh believe a chemical messenger that is essential for developing a baby’s gut in the womb could hold the key to new treatments for inflammatory bowel disease (IBD), a
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GlaxoSmithKline and XenoPort, Inc. announced today that GSK has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
The FDA had requested that the data in a single study be reformatted. In addition, GSK conducted a review of other clinical studies taking this input into account. The withdrawal was not related to the content of the filing.
GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
Solzira - is a new chemical entity that is designed to improve upon the pharmacokinetics of gabapentin by taking advantage of high-capacity transport mechanisms in the gastrointestinal tract to improve absorption.
Teva Pharmaceutical Industries Ltd. has announced that its subsidiary, Teva Pharmaceuticals USA, Inc., has signed an agreement with AstraZeneca to settle patent litigation involving Teva’s U.S. generic version of AstraZeneca’s Pulmicort (Budesonide) Respules including all claims for patent infringement and damages. Teva launched its generic budesonide respules in the U.S. on November 18, 2008. The
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VistaGen Therapeutics and the Wisconsin Alumni Research Foundation (WARF) have signed a license for human embryonic stem cell patents for the development and commercialization of stem cell-based research tools. VistaGen, a biotechnology company based in South San Francisco, is one of the world’s leading companies focused on using the power of stem cell technology to
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Mylan Inc. has announced that its subsidiary, Mylan Pharmaceuticals Inc., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg. Fluoxetine Capsules, indicated for the treatment of premenstrual dysphoric disorder (PMDD) are the generic version of Eli Lilly’s
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Scientists at an international conference have been warned that the next casualty of the credit crunch could be new drugs. The warning says the current global financial crisis could well threaten and seriously delay the discovery and production of many new life-saving medicines. The warning has come from Professor David Wield, the Director of the
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According to findings from a National Diabetes Economic Barometer study, undiagnosed, pre-diabetes and diabetes cost the United States an estimated $217.5 billion in 2007 due to higher medical expenditures and lost productivity. The research shows that beyond the estimated $174 billion that is widely-accepted as the cost of diagnosed diabetes in 2007, an additional $18
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