The Alliance For Regenerative Medicines is calling for advanced therapies to be given greater priority where joint clinical assessments are concerned.
The Council of the European Union has finally agreed its negotiating position on the European Commission’s proposals to introduce new legislation that would boost cooperation on health technology assessments across the EU.
One pharmaceutical industry source following the debate said the council’s position showed “a lack of trust” that could undermine a...
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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.
The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.
