Trends-in-Medicine| Publisher: | Stephen Snyder |
| Writers: | Lynne Peterson |
| Marta Weber | |
| Diana Woods | |
| Editors: | Susie Bellitta |
| Kathleen Snyder | |
| Betty Teel | |
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© 2004
No articles may be reproduced without written permission of the publisher.
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The FDA’S Cardiovascular and Renal Drugs Advisory Committee Rejects Astrazeneca’s Exanta - Quick Pulse
Summary: It was clear from the advisory committee’s briefing documents that AstraZeneca would have a difficult time getting panel – and probably full FDA – approval for Exanta (ximelagatran), and the actual meeting went even worse than expected. The panel determined nearly unanimously that Exanta is not safe and that the benefits do not outweigh the risks in any of the three proposed indications. The panel was concerned about liver damage and possibly a heart attack risk when used short-term. It is now virtually certain that the FDA will not approve Exanta, and the outlook for an approvable letter also is dim.
Macugen Report - Quick Pulse
Summary: Eyetech and its marketing partner, Pfizer, are seeking FDA approval of Macugen (pegaptanib Eyetech's Macugen (pegaptanib sodium by intravitreal injection) got a resounding vote of confidence from an FDA advisory committee, which recommended approval for the treatment of all subgroups of wet (neovascular) age-related macular degeneration (ARMD/AMD). This report details the FDA panel meeting.
European Society of Cardiology (ESC) - Quick Pulse
Summary: There was lots of news this year at the European Society of Cardiology meeting -- information on drug-eluting stents as well as drugs in development, including Lilly’s antiplatelet drug, prasugrel (CS-747); Mylan/Menarini’s beta blocker nebivolol; Sanofi-Aventis’s Acomplia (rimonabant) for weight loss and smoking cessation.
Intensity Modulated Radiation Therapy (IMRT)
Summary: Hospitals have money in their budgets for linear accelerators, and they generally are purchasing new IMRT-capable machines rather than upgrading older machines. IMRT is becoming more mainstream, but the market is not yet mature. Reimbursement is expected to decrease, but that is not likely to affect usage. Sites that have IMRT are using it; very few IMRT-capable linacs are not being used for IMRT. IGRT is still relatively new, and few hospitals and clinics other than leadingedge institutions plan to purchase it in the next year, but an average of 33% of sources said they plan to adopt it within four years – as new equipment, not upgrades. TomoTherapy is attracting a great deal of interest, and sources view it as a serious threat to Varian, in particular, but few institutions plan to buy it in the next year.
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