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PhRMA called on the U.S. trade representative to assess threats and barriers to intellectual property in 18 countries, and to focus in particular on China, India, Colombia, and Canada. Read More
Three senators urged newly confirmed secretary of HHS, Tom Price, to fast track the importation of certain prescription drugs from Canada following “significant or unexplained” increases in U.S. prices. Read More
The EMA said 30 drugs across four therapeutic classes have received conditional marketing authorization in the EU since the expedited approval pathway became available a decade ago. Read More
The World Trade Organization ratified an amendment to the Trade Related Aspects of Intellectual Property Rights (TRIP) agreement, authorizing developing countries with limited production capacity to import generics when facing a drug shortage. 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
Aspen Pharma and Deco Pharma, the company’s distributor, face disciplinary proceedings from Spain’s antitrust authority for allegedly limiting the distribution and hiking the prices of drugs. Read More
Advanced therapy medical products are facing several development hurdles, ranging from inadequate regulatory guidance to insufficient funding, the EMA said. Read More
The International Council on Harmonization is proposing to expand guidance concerning data quality, medication errors and product issues by developing a companion document that would include a Q&A section and more examples. Read More
The FDA finalized guidance on the GMP requirements for combination products, adding scenarios to clarify how manufacturers can comply with requirements. Read More
More than 160 biotech executives, investors and researchers signed a letter opposing President Trump’s executive order restricting immigration from seven Middle Eastern and African nations. Read More