Deals Update (01/2008)
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.
Teva’s ‘Skinny Label’ Dispute Edges Toward Supreme Court With Government’s Backing
US Solicitor General urges the Supreme Court to grant Teva's petition, arguing that the Federal Circuit was wrong in ruling that Teva's carved-out labeling for generic carvedilol induced infringement of GlaxoSmithKine's brand product.
UK Updates Guidance To Reflect EU Medtech Extensions
The EU’s decision to extend the Medical Device Regulation transition periods for legacy medical device directives products will be mirrored in the UK, which also continues to evolve its post-Brexit medtech regulatory system.