EMA Backs Approval For Eight New Drugs But Rejects Lagevrio For COVID-19
Janssen’s Akeega is among the latest drugs that the European Medicines Agency says should be approved for use in the EU. Meanwhile, MSD/Ridgeback Biotherapeutics plan to appeal the agency’s rejection of their COVID-19 treatment.
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Chiesi Returns To Respiratory Roots With Affibody Pact
A busy start to the year sees the Italian firm adding to its respiratory portfolio by gaining access to the Swedish biotech’s investigational inhaled treatments.
J&J Wins EU Nod For Akeega To Go Up Against AZ/MSD’s Lynparza In First-Line mCRPC
Akeega, a combination of GSK’s PAPR inhibitor Zejula and J&J’s antiandrogenic drug Zytiga, has won a positive opinion from the CHMP in a lucrative first-line prostate cancer setting, hot on the heels of a broader approval for AstraZeneca’s blockbuster Lynparza.
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 EU, and updates on EU marketing authorization changes recommended by the CHMP.