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The European Medicines Agency for the first time published data on its clinical data website from a withdrawn application, while adding clinical study reports for two generics. Read More
Japan’s largest drugmaker, Takeda Pharmaceuticals, said it will maintain its existing pricing model in the U.S., despite President Donald Trump’s call for drug companies to lower their prices. Read More
The European Parliament’s committee on Environment, Public Health and Food Safety voted Tuesday to approve a draft report that includes dozens of recommendations for improving how the EU promotes access to medicine and handles safety, intellectual property, and pricing issues. Read More
Leading drug firms and PhRMA have weighed in on the FDA’s plan to study the risks and benefits of online prescription drug communications and the possible impact of space limitations such as Twitter’s 140-character limit. Read More
Italian regulatory authorities have ordered a ban on drug substances and bulk products manufactured by Antibióticos Do Brasil after an inspection revealed several GMP deficiencies, ranging from data integrity to quality management issues. Read More
PhRMA is urging the USPTO to reevaluate patent eligibility for prescription drugs to provide the drug industry a better framework for interpreting regulations and recent case law. Read More