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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.

US FDA May Play Central Role In Assuring Access To Mifepristone Post Roe v. Wade

HHS will take steps to increase access to abortion medication and prevent states from banning it, Secretary Becerra says, but also is questioned about whether the FDA can speed up certification of pharmacies and if the Justice Department would sue states banning access.

Otsuka/Lundbeck Closer To Adding Alzheimer’s Agitation To Rexulti Label

With no currently approved treatment for agitation in Alzheimer’s disease, analysts see a solid revenue opportunity for Rexulti. The companies plan to file a supplemental NDA later this year.

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