THE DRUG DOCKETThe CHMP's June meeting recommended pulling avacopan from the EU market on data-integrity grounds, refused three cell and biological therapies, and reversed itself on a Rett syndrome drug it had earlier rejected.
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THE DRUG DOCKETThe European Medicines Agency's March meeting produced five positive opinions, three of them for orphan-designated cancer and rare-disease treatments already available in some other markets.
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THE DRUG DOCKETThe CHMP's November meeting produced ten positive opinions. Two of them — teplizumab and a Telethon-sponsored gene therapy — address conditions the EU has had no authorised treatment for.
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THE DRUG DOCKETBrensocatib cleared CHMP on an accelerated timetable with a 19.4% cut in exacerbation rate. The same October meeting issued a negative opinion on belumosudil and kept a sickle cell drug suspended.
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Seven of those nine were denosumab. The committee's September opinions also covered an RSV antibody for infants, a first EU treatment for IgG4-related disease, and four withdrawn applications.
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