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European CHMP Opinions and MAA Updates

Executive Summary

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

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New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with two new products including Merck Sharp & Dohme's Ebola vaccine, Ervebo. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

The Stakes Are High So Get It Right

The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. Consultant Kate Dion highlights to In Vivo helpful tips for companies facing this daunting situation.

Vertex Inks Another Orkambi Reimbursement Deal After France Says Yes

The reimbursement deal will allow cystic fibrosis patients as young as two years of age to access Orkambi in France for the first time.

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