As a word to the wise in a week filled with FDA advisory committee meetings on potential new opioid drugs, the state of Oklahoma filed a lawsuit Monday against three distributors, reminding everyone in the U.S. opioid prescription supply chain of the risk of litigation and hefty penalties.
Cambridge, Mass.-based Blueprint Medicines Corp.’s price tag and label for Ayvakit (avapritinib) caused some chagrin on Wall Street as observers continued to weigh the drug’s odds against ripretinib, the competing drug for which Deciphera Pharmaceuticals Inc. awaits regulatory action.
PERTH, Australia – Although Australia’s deadly bushfires continue to burn, and conditions are expected to worsen later this week as temperatures rise, Australia’s Therapeutic Goods Administration (TGA) is not anticipating any effect on business operations.
For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics. As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26.
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