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Two Hopefuls And A ‘No’: EMA Decisions On Accelerated Access

 
• By Neena Brizmohun

Regeneron and Shire should find out this week whether the European Medicines Agency will agree to fast-track its review of their products.

Hands writing on a paper
Two applications for fast-review will be considered at this month's CHMP meeting

Regeneron Pharmaceuticals and Shire will learn this week whether their investigational treatments for cutaneous squamous cell carcinoma (CSCC) and hereditary angioedema respectively will be fast-tracked in the EU when the companies file for approval. Meanwhile, Johnson & Johnson’s bid for accelerated assessment of its novel prostate cancer drug, apalutamide (Erleada), has failed.

Applications for the accelerated assessment of Regeneron's cemiplimab (REGN2810) and Shire's lanadelumab (SHP643) are set to be considered...

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