Leonard Wydotis has retired as president of the generic drug manufacturer. Chelsea's parent company, Rugby-Darby Group, said that a plan to move the Chelsea president from New York to Monroe, North Carolina, the location of Chelsea's manufacturing headquarters, was the reason behind Wydotis' decision to retire. A search is underway for a replacement. Chelsea has been under FDA scrutiny because of alleged untrue statements and discrepancies in manufacturing records for certain ANDAs. FDA is planning to withdraw ANDAs and downgrade the therapeutic rating for five drugs to therapeutically inequivalent and, reportedly, is reviewing over two dozen of Chelsea's ANDAs for batch record and formulation inconsistencies.
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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.
