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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
Buried deep in the administration’s budget proposal are a series of drug price control measures that could rattle the pharmaceutical industry. Read More
The full Senate is scheduled to decide on Feb. 22 whether Robert Califf should be the next FDA commissioner, after Majority Leader Sen. Mitch McConnell (R-Ky.) scheduled a cloture vote late Thursday. 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
Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More
The UK’s Department of Health and NHS England have failed to manage the Cancer Drugs Fund effectively by not carrying out its intended purpose and significantly outspending its budget, according to a report released by the UK Parliament’s House of Commons. Read More