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Deals Update (01/2008)

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.

EMA Recommends Dozens Of Suspensions Over Flawed Synchron Studies

The European Medicines Agency's human medicines committee has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.

Sun Pharma Grows OTC Offering In Romania With Uractiv Brand Acquisition

India's Sun Pharma has expanded the portfolio of its Romanian subsidiary Terapia with the acquisition of the Uractiv urinary tract health brand.

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