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Six new drugs have scored wins at the European Medicines Agency, scooping up recommendations for marketing authorization from the Committee for Medicinal Products for Human Use. Read More
An NHS England spokesperson confirmed Feb. 18 that the agency will investigate whether more than 130 NHS staff involved in assessing drugs were also paid as consultants by drugmakers. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues. This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
After years of uncontrolled spending, the UK’s troubled Cancer Drugs Fund has presented the National Health Service with a restructuring plan to get back on track. Read More
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