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Latest From Maureen Kenny
Anticipating pan-EU approval of Epidyolex within the next six months, GW Pharmaceuticals is gearing up to launch what would be the first plant-derived cannabinoid medicine to be approved under the EU centralized procedure.
Accelerated assessment requests at the European Medicines Agency.
The European Medicines Agency will fast-track Shionogi’s new antibiotic, , through regulatory review when the company files for approval but there’s no special treatment for Roche’s new tissue agnostic oncologic, . More than half the accelerated assessment requests made in 2018 to the EMA failed to make the grade.
The BeNeLuxAI initiative was among the many topics covered at the DIA Europe 2019 conference in Austria last week. The cross-country coalition has some new drugs in its sights for joint pricing talks and the conference was given an insight into the workings of the collaboration by a Belgian health department advisor close to the initiative.
EU regulators have been working on a project to help determine the potential role of big data in medicines assessment for almost two years. They will soon be ready to release their keenly awaited conclusions.
In 2018, the European Medicines Agency considered 24 requests from drug companies for fast-track review of their planned marketing authorization applications. The agency has granted at least nine requests, eleven have been rejected and the results of four have yet to be disclosed.