Deals Update (01/2008)
A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.
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Drug companies involved in Alzheimer's disease research are a little fed up with FDA. Some, like Wyeth, believe the agency should put Alzheimer's research higher up on its priority list and allow the use of surrogate endpoints for clinical trials. But FDA says that no validated surrogate exists for Alzheimer's, and until it has hard data from products in development, it is loath to recommend one. A recent reorganization of the agency's neurology group may provide an opening to press home those arguments.
Myriad has sold several business units as it narrows its focus to oncology, women's health and mental health diagnostics. CEO Paul Diaz says the moves will allow the company to be a market leader.
US FDA’s Accelerated Approval process has always been a deceptively simple idea. After a three-day public review of ‘dangling’ applications, the underlying complexity remains.