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.
P&G's $8M Benzene Settlement Preliminarily Approved By Ohio Federal Court
The Cincinnati, OH-based firm will pay $8m to recompense Unites States residents who purchased aerosol personal-care products potentially contaminated with benzene over a roughly six-year period.
Food For Thought On US FDA Reforms
An independent review of the US FDA’s food regulatory programs could renew a debate over splitting FDA into two agencies. That could be a distraction for the agency in the coming year – but it could also help keep the medical product review groups out of the political hot seat.