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First Oral Treatment For Spinal Muscular Atrophy Gets EMA Nod

Two Of Six Drugs Recommended For EU-Wide Use Have Orphan Designation

Executive Summary

New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.

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UK Approves Regeneron/Roche MAb Cocktail For COVID-19

The UK has pipped the EU to the post in granting a marketing authorization to what the health secretary describes as “a significant addition to our armoury to tackle COVID-19.”

EU Accelerated Assessment Tracker

Novartis is trying its luck with capmatinib on the accelerated assessment front at the European Medicines Agency. Gilead and Astellas/Seagen have secured fast-track review for their respective potential new products while Sesen Bio and Amryt Pharma are dealing with rejection.

EU Accelerated Assessment Tracker

One out of seven requests for the accelerated assessment of planned EU marketing authorization applications is known to have been granted this year to date.

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