Obesity Drug Risks Prompt New EU Drug Data Disclosure Rule
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Europe’s drug regulator will make thousands of pages of clinical trial reports public next week after pressure from drug-safety activists because of suicide risks linked to Sanofi-Aventis SA’s failed diet pill Acomplia.
The European Medicines Agency will from next week provide data on request for every drug it has reviewed, Sabine Haubenreisser, an EMA spokeswoman, said Nov. 17. The agency aims to publish the reports on its website within five years, Executive Director Thomas Loenngren said.