A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.
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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.
Manufacturers have different production timelines and US FDA advisory committee members worry a June strain selection may not fit the timing of COVID-19 case surges.
The Danish firm’s four key products yielded 31% sales growth in 2022, and the company is investing in the anticipated mid-year launch of an Alzheimer’s agitation indication for Rexulti.