Best of the Blog: IN VIVO, September 2008
Highlights of our blog coverage for September 2008 included ongoing coverage of the financial crisis and how the broader financial woes may manifest in the world of healthcare financing.
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FDA is missing more new drug review deadlines: at least seven in the first eight months of this year. The experiences of those delayed applications indicate some interesting ways to interpret what it means when a user fee date comes and goes without an FDA decision. One clear observation: the longer a sponsor has to wait after the user fee deadline, the worse the likely result.
Issues of clinical trial design are at the forefront in Alzheimer's drug development. Researchers and investors are weighing the impact of late-stage failures, even as significant unknowns remain about disease mechanism and the correlation of biochemical markers and clinical effects. A fundamental question hangs over AD drug development, which is unique in many respects: in deciding how to move from Phase II into Phase III, what can you know and how can you know it?
Eli Lilly has hedged its bets on its two late-stage Alzheimer's disease candidates. In a deal with TPG-Axon and Quintiles' partnering group NovaQuest, Lilly sheds risk (and potentially reward) in this notoriously difficult therapeutic space. A model for private equity / pharma deals going forward?