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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.
A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.
The European Medicines Agency says it will become more systematic in seeking explanations from companies who delay or withdraw their planned marketing submissions and in chasing “no-shows.”
A novel TYK2 inhibitor and a drug to treat an ultra-rare genetic disorder are among products up for a marketing authorization opinion this week from the European Medicines Agency’s human medicines committee, the CHMP.
The European Medicines Agency is working on restarting its landmark policy on publishing clinical trial data, with the first phase expected to start this year.
EU regulators have developed new guidance to help companies steer through the transparency requirements in the Clinical Trials Information System and protect personal and commercially confidential information in submissions.