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Top US pharma stories of 2012

This article was originally published in SRA

Executive Summary

Did you read Scrip Regulatory Affairs' coverage of the most business-critical developments in US pharmaceutical regulatory affairs in 2012?

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EU Accelerated Assessment Tracker

EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.

EU Fast-Track Loss For Vertex’s CF Triple Combo

Vertex is hoping for EU approval in Q4 of its cystic fibrosis triple combination therapy, Trikafta. It wants the same licence in the EU as it has in the US, where the product has already become a best seller for the company.

EU Speedy Review Success For Kite But Not For Lilly

KTE-X19, Kite’s potential new CAR-T therapy, will in the end be fast-tracked at the European Medicines Agency. Lilly failed to secure the speedy review it was seeking for selpercatinib

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