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.
Cosmetics companies that disclose the presence of PFAS in their products and explain measures they are taking to minimize PFAS’ presence are better protected from lawsuits, says Dentons US attorney Michael Duvall.
Pharma-related regulatory issues are dominant in the latest annual White Paper from the EU Chamber of Commerce in Korea, accounting for 22 of the 96 concerns raised across 18 industries that will be shared with ministries. Quality of life issues around drugs for chronic disorders, risk-sharing agreements, reimbursement and vaccine policies are some of the key questions raised.