AtheroGenics expects the ARISE trial of its oral atherosclerosis agent AGI-1067 will be complete in first-quarter 2006 following FDA's approval of a protocol amendment. Among the changes made to the Aggressive Reduction of Inflammation Stops Events protocol are an increase in patient enrollment from 4,000 to 6,000 and a decrease in the target number of clinical events from 1,160 to 990. FDA is also permitting the elimination of a 12-month minimum follow-up period. AtheroGenics says the amendment will not affect its special protocol assessment of ARISE with FDA...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
