Deals Update (01/2008)
Executive Summary
A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.
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Rethinking Alzheimer's: Mapping Out an Approval Process
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.
QUOTED. 6 May 2020. Paul Diaz.
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.
After ODAC: The State Of Accelerated Approval At The US FDA
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.