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Moment Of Truth For Pacritinib And Other EU Approval Hopefuls

Executive Summary

CTI BioPharma has had a bumpy ride with pacrotinib, its investigational treatment for patients with myelofibrosis who have thrombocytopenia. But it has persevered and should learn this week whether the European Medicines Agency will recommend that the product be approved for the sale across the EU. Pacritinib, J&J's apalutamide, and AEterna Zentaris's macimorelin are among a handful of products reaching the end of the approval process.

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With its final meeting of the year under way, the EMA's medicines evaluation committee, the CHMP, will bring seasonal cheer for some companies if it decides their products merit EU approval. New treatments from Shionogi and Medac are up for an opinion. A planned appearance by Portola before the panel to answers questions relating to its marketing application for Ondexxya/AndexXa has been cancelled and the review period for the marketing authorization application for the product extended.

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The European Medicines Agency this week recommended marketing approval for four medicines, including a drug for use in countries outside the EU.

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