The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.

Alongside CSL/Behring/uniQure’s Hemgenix (etranacogene dezaparvovec), the European Medicines Agency has given the green light to new drugs for liver cancer, NSCLC, Pompe disease and multiple sclerosis. But it turned down omburtamab for treating the rare cancer, neuroblastoma.  

Accord and Sandoz were the big winners at the Global Generics & Biosimilars Awards 2022 in Frankfurt, with other firms recognized including Beximco, Centrient, Dr Reddy’s, Eurofarma, Samsung Bioepis, Shanghai Henlius Biotech and Stada, as well as the US Biosimilars Forum.

The European Medicines Agency has delivered its verdict on marketing applications for a raft of new medicines.