Flying Through FDA: Test Runs For Pilot 1
FDA's Pilot 1 rolling review process has led to accelerated approvals for cutting edge therapies. In addition to smaller biotechs, some of the largest pharmaceutical companies in the world are using it - and having success. FDA's top drug reviewer tells you how to maximize the value of the temporary program.
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FDA is unlikely to make permanent its rolling review, fast-track Pilot 1 program. The agency says logistics are the key reason for the program's termination.
Not the most obvious of biotech-biotech combinations. OSI thinks it can make money from Eyetech's lone product pegaptanib (Macugen), a breakthrough new treatment for age-related macular degeneration. The market has reacted poorly to the deal, worried that Macugen will be made obsolete by Genentech's Lucentis, due to be launched in late 2006.
Accelerated approvals are decelerating. Sponsors argue the FDA is so caught up in the current emphasis on safety that they're raising the AA efficacy standards. The FDA contends that the companies who have been rejected aren't meeting the efficacy standards or performing the promised follow-up trials. Is the FDA changing the rules-or are companies themselves bending them? A look at several recent cases of AA therapies reveals that both are true.