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Latest From Maureen Kenny
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.
The UK government has issued guidance on actions the public health and care system in England should take to prepare for and cope with a potential “no deal” exit by the UK from the EU at the end of March next year. The government is also very clear on what it does not want providers such as hospitals and community pharmacies to do – stockpile medicines.
Seven new drug applications got the thumbs up this week from the EMA's drug evaluation committee, the CHMP. Their EU approval should now be a formality. Two new Shionogi treatments are set for approval, as are two orphan products – one from Medac, the other from AOP Orphan Pharmaceuticals. Pfizer got the OK for one biosimilar but has withdrawn an application for another.