Deals Shaping the Medical Industry (10/07)
The dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, pharmaceuticals, medical devices, and research/analytical instrumentation and reagents. All transactions are excerpted from Windhover's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.
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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.
The latest medical device user fee (MDUFA) reports seem to indicate the percentage of premarket applications that receive a major deficiency letter are starting to come back up. US FDA says a key reason for the letters is because of insufficient testing information from device sponsors. The agency offers some steps that sponsors can take to avoid getting one of the dreaded missives.
Sponsors of PMA or HDE-authorized devices can make some modifications in response to COVID-19 without first alerting the US FDA under a recent guidance document.