ERC Not Giving Up On Glioma Immunotherapy In EU
EMA Concerned Over Biosimilar Eptacog Alfa Manufacturing
ERC Belgium has pledged to collect more data to convince the European Medicines Agency that Sitoiganap merits approval. Meanwhile, UGA Biopharma said it would address the agency’s objections over its biosimilar version of eptacog alfa.
You may also be interested in...
Japanese bioventure Stella Pharma is re-designing a Phase II trial for its glioma candidate Steboronine after it was determined the original primary endpoint was not robust enough to prove efficacy, a challenge faced by some others working in the difficult indication. The drug was approved for head and neck cancer in Japan in 2020 and Stella has already announced a new collaboration which may be key to moving forward.
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.
The European Medicines Agency’s human medicines committee, the CHMP, is expected to decide whether 11 drugs should be recommended for marketing approval during its latest monthly meeting, which started today.