Anavex Pursues European Strategy Shift Following Regulatory Setback

Biopharmaceutical firm Anavex Life Sciences is charting a new course in Europe after a recent regulatory challenge. The company is joining a major European Alzheimer’s therapeutic initiative, signaling a determined effort to advance the approval pathway for its lead drug candidate, Blarcamesine.

Concurrent with its European repositioning, Anavex has received encouraging feedback from the United States Food and Drug Administration (FDA). Following a meeting in early January, the FDA expressed interest in the clinical results for Blarcamesine and invited the company to submit its data. Discussions included potential avenues for a future marketing application. Anavex is now preparing to present existing data from its Phase-IIb/III study. This transatlantic Read more...