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European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Read More
With 12 nations signing off on the Trans-Pacific Partnership, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Read More
Regular price reevaluations can lower drug prices in individual European countries, but the only way to ensure significant price cuts is through EU-wide collaboration, according to a new report. Read More
Cynthia Schnedar, director of CDER’s Office of Compliance, is leaving to pursue opportunities in the private sector, Janet Woodcock said Monday in an emailed message. Her last day will be March 18. Read More
European regulators have signed off on Teva Pharmaceutical Industries’ planned $40.5 billion purchase of Allergan’s generics unit, provided the company sells off numerous overlapping product areas to address anti-competitive concerns. Read More