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BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up

Tanezumab’s Modest Impact On Osteoarthritis Pain Draws Negative CHMP Opinion

Executive Summary

A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval. 

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EU CHMP Opinions and MAA Updates

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.

Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod

Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.

One In, One Out: Mirum Seeks New EU Indication For Maralixibat, Withdraws Another

Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.

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