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Roche Takes Orphan Satralizumab To EMA

Fast-Track Review Is Planned For The New Immunosuppressant

Executive Summary

There are six new entries on the latest list of products under review at the European Medicines Agency – products with orphan status from Roche and Novo Nordisk and four generic or biosimilars.

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EU Accelerated Assessment Tracker

The European Medicines Agency this year is known to have granted ten requests for accelerated assessment of planned EU marketing authorization applications. Nine such requests are known to have been rejected. As 2019 draws to a close, the outcomes of five requests are still unknown.

EU Accelerated Assessment Tracker

Janssen’s two investigational Ebola vaccines are among four new products recently granted fast-track review by the European Medicines Agency. GlaxoSmithKline and Viiv Healthcare are not disclosing the outcomes of accelerated assessment requests they have made.

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Roche has secured accelerated assessment at the European Medicines Agency for its new immunosuppressant, satralizumab. The outcomes of five other fast-track requests that companies have made for their planned marketing authorization applications are still unknown.

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