Deals Update
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.
Merck Suit Against Medicare: Constitutional Arguments Are Scathing, But Are They Persuasive?
A suit designed to test the limits of the protections against judicial review that are embedded in the IRA could have more traction, some legal scholars suggest.