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FDA Proudly Announces Its First Approval of an Interchangeable Biosimilar
On July 28, 2021, the Food and Drug Administration (FDA) announced the approval of the first “interchangeable biosimilar”—in this case Mylan Pharmaceticals Inc.’s Semglee® (insulin glargine-yfgn),...
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Federal Policymakers: Chasing the Runaway AI Train
The U.S. is generally viewed as “behind” in its regulation of AI compared to the European Union and Asian countries. Yet ChatGPT’s release triggered a tsunami of U.S. legislation in 2023 from federal...
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A Win for Skinny Labels; Insights for Enforcing Use Patents
Most drugs are covered by multiple patents, with initial patents directed broadly to the compound and later patents directed to increasingly narrower uses of the compound. This provides opportunities...
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