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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
Teva Pharmaceuticals has been named in a patent infringement lawsuit as it attempts to develop a generic version of Belbuca, a long-acting opioid painkiller sponsored by BioDelivery Sciences International and Arius Two. 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