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Yondelis Experience Highlights EMEA Issues

Executive Summary

The European regulators' rejection of PharmaMar's lead anti-cancer drug Yondelis in November 2003 was a significant setback for Spain's flagship biotech. But the decision was close; some experts still feel the drug should have been approved. Indeed, although critics claim PharmaMar could have done more to ensure its trial design was satisfactory, the experience highlights weaknesses in Europe's centralized drug approvals procedure of which other firms should be aware. All the more so since the centralized route will likely soon be compulsory not only for biologics, but also for all products in cancer, HIV/AIDS, neurodegenerative disease and diabetes, and all designated orphan drugs.

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Transatlantic Tit For Tat

Echoing other transatlantic rifts, FDA commissioner Mark McClellan argues that America, with its unrestricted drug pricing, is paying Europe's drug R&D bill. Pharma companies agree. European authorities-the only faction with the power to alter pricing policies-don't. But the public disagreement hasn't prevented closer cooperation between the FDA and the EMEA. The agencies' recently announced confidentiality agreement paves the way for better information sharing and could simplify the complex European regulatory arena. But it won't necessarily speed approvals-some drug firms argue that it may even slow them down.

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