European CHMP Opinions and MAA Updates
Executive Summary
This is a monthly 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.
You may also be interested in...
Finance Watch: VC Mega-Deals Launch Biopharma Firms With New Takes On CV, Genetic Diseases
Anthos premiers with $250m from Blackstone and cardiovascular disease assets and expertise from Novartis, while Maze brings in $191m for drugs that target gene modifiers. In public company financings, Sage raises $575m ahead of Zulresso approval decision.
EU CHMP Backs Three Conditional Approvals & Several Treatment Firsts
Akcea’s Waylivra, Portola’s Ondexxya, BioMarin’s Palynziq, AbbVie’s Skyrizi and Pfizer’s Lorviqua are among new drugs to receive a positive opinion from the EU’s CHMP at its latest monthly meeting.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.