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Latest From Ian Schofield
A meeting between the European Medicines Agency and representatives of the East African Community discussed whether the European agency could act as a model for a regulator in the six-country region.
Smaller biopharmaceutical firms are increasingly making use of the EU’s centralized approvals procedure and the EMA’s scientific advice and other support services, and are also proving to be keen users of the agency’s priority medicines scheme (PRIME), accounting for half of all PRIME applications in 2016.
The criteria that candidates seeking to host the European Medicines Agency post-Brexit will have to meet are out for discussion among member state representatives and should be finalized towards the end of June. Formal bids will have to be in by July end and a decision on the EMA’s new home should be made in October.
The EMA’s main scientific committee, the CHMP, has rejected AB Science’s potential mastocytosis drug masitinib, but the company has asked for a re-examination of the decision on a number of grounds, including the fact that it has implemented GCP corrective actions and that updated information shows the product to have “acceptable” long-term safety.
The European Medicines Agency has given the thumbs-up to Insulin lispro Sanofi, the first biosimilar version of Lilly’s diabetes drug Humalog. It has also green-lighted three more biosimilar rituximab products from Celltrion, which already has EU approval for one version of the originator product, Roche’s MabThera.
In March, the number of proposed new drug brand names rejected by the European Medicines Agency exceeded those that were accepted. A dedicated group at the agency is to look into the problem at a meeting with stakeholders on June 1.