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The FDA will proceed with using a nonproprietary naming approach that relies on arbitrary four-letter suffixes to distinguish biosimilars and biologics, showing a disregard for industry concerns in a lightly tweaked final guidance that adds a few new considerations for suffix proposals. Read More
The European Parliament’s committee on Environment, Public Health and Food Safety voted to approve a draft report that includes dozens of recommendations for improving how the EU promotes access to medicine, prioritizes generics, and handles intellectual property, and pricing issues. Read More
The Office of Management and Budget clarified President Trump’s new “one in, two out” regulations order, narrowing its scope to significant regulations with an economic impact of over $100 million per year, and new guidance documents considered on a case-by-case basis. Read More
Sponsors seeking approval for an interchangeable biosimilar should plan to conduct a switching study using a U.S.-licensed comparator product and primary endpoints that assess clinical pharmacokinetics (PK) and pharmacodynamics (PD). Read More
Two lawmakers behind the Cures Act have asked the Office of Management and Budget to clarify whether the federal hiring freeze applies to the FDA, raising concerns that the freeze could disrupt the implementation of the bipartisan law and the passage of user fee agreements. Read More
Two congressmen introduced right-to-try legislation in the House this week, which could find broad support from Congress and the White House. Read More
More than 160 biotech executives, investors and researchers have signed on to a letter opposing President Trump’s executive order restricting immigration from seven Middle Eastern and African countries. Read More