AstraZeneca Opts for Regulatory Flexibility
Executive Summary
Pharmaceutical companies often pursue the more flexible Mutual Recognition Procedure over the rigid centralized process when applying for marketing authorization in Europe. They're right to do so-as AstraZeneca's recent experience with Crestor shows, even when the MRP's flexibility gets in the way of Europe-wide approvals, the process can be safer than the alternative.
You may also be interested in...
Senexis Ltd.
Senexis Ltd. spun-out of the University of Manchester Institute of Science and Technology to develop novel therapeutics and diagnostics for currently incurable aging-related disorders such as Alzheimer's disease, Parkinson's disease and type 2 diabetes. In addition to being more prevalent in the older population, these diseases also share a similar underlying etiology; they are all associated with amyloidosis.
Working Around Pre-Emption Rights
Europe's pre-emption rights significantly hamper biotech fundraising. But since they're unlikely to go away, European firms are having to find clever ways around them.
Private Device Companies Step-Up to the Public Market
Encouraged by successes in the biotech space, public market investors' interest in the device arena has returned in 2004 to support 10 companies' IPOs so far. Windhover's analysis of the valuations achieved indicate that private investors in these companies have, on average, enjoyed larger returns than their biotech counterparts.