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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
Democratic members of Congress have asked President Trump how the federal hiring freeze will affect the FDA’s user fee program, which are set to be reauthorized later this year. They account for 42 percent of the agency’s budget. Read More
President Donald Trump hosted the leaders of PhRMA for a White House meeting on the state of the pharmaceutical industry and the FDA, saying that drug prices have been “astronomical” and pledging cuts to regulations. Read More