BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up
Tanezumab’s Modest Impact On Osteoarthritis Pain Draws Negative CHMP Opinion
A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval.
You may also be interested in...
BeiGene’s Brukinsa Set To Take On Imbruvica With CLL Approval
The BTK inhibitor demonstrated superiority to AbbVie/J&J’s Imbruvica for overall response in relapsed/refractory CLL, in addition to hitting a progression-free survival endpoint versus chemotherapy in the first-line.
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.