Trends-in-MedicineLynne Peterson,
Senior Writer
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright© 2003
No articles may be reproduced without written permission of the publisher.
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Boston Scientific's Taxus Stent gets FDA Panel Recommendation - Quick Pulse
Summary: The FDA’s Circulatory System Devices Panel voted unanimously on November 20, 2003, to recommend approval of Boston Scientific’s Taxus (paclitaxel-eluting) stent. The panel put five conditions on approval. This Quick Pulse summarizes the panel discussion and votes.
FDA Panel to Consider Two Collagen Fillers - Quick Pulse
Summary: The FDA’s General and Plastic Surgery Devices Panel is scheduled to review both Medicis’ Restylane (non-animal hyaluronic acid) and Inamed’s Hylaform (a hyaluronic acid-based dermal filler) on November 21, 2003. Based on interviews with six dermatologists including three Restylane researchers, the key Restylane issues are likely to be safety concerns.
American Neurological Association
Summary: Elan/Wyeth’s Alzheimer’s Disease vaccine, AN-1792, may be revived. The outlook is for widespread use both on-label and off-label of Forest Lab’s Namenda (memantine) for Alzheimer’s disease. The various atypical antipsychotics perform quite differently from each other in bipolar disorder and in Parkinson’s Disease. The failure of Biogen’s antegren in Crohn’s Disease does not predict how the drug will do in multiple sclerosis. Both Teva’s Copxaone and Ares Serono’s Rebif are expected to continue to gain market share, mostly at the expense of Biogen’s Avonex. New research also suggests that Copaxone may work in MS – and other neurodegenerative diseases – when given monthly or even less frequently, and investigator-sponsored trials are being planned. Pfizer’s pregabalin for neuropathic pain is generating little excitement and is viewed by many doctors as a me-too drug.
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