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.’
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.
