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The Pharmaceutical Research and Manufacturers Association singled out China and Canada as two of the 20 countries to watch for intellectual property transgressions in 2016. Read More
Drugmakers submitting anonymized clinical data in applications to the EMA must keep up on technology advances that could put that data at risk for re-identification. Read More
The European Medicines Agency and the European Commission published new track-and-trace safety requirements Feb. 10 affecting all drugmakers doing business in EU countries. Read More
An FDA advisory committee gave South Korea’s Celltrion’s biosimilar candidate for Remicade a strong show of support Feb. 9, backing its approval for six indications. Read More
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