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With Hollywood celebrities speaking out both in favor of and against the use of drugs like Ozempic and Wegovy for weight loss, it was only a matter of time before demand outpaced supply. Although most might believe that...more
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more
A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse...more
As businesses across the globe grapple with the changing realities presented by the COVID-19 pandemic, U.S. and international antitrust enforcers have warned that business should continue to mind the antitrust laws. Global...more
FDA recently issued final guidance for industry on citizen petitions and requests for stays of agency action that may delay the approval of certain drug and biological product applications....more
• The International Trade Commission (ITC) can decline to institute an investigation when a complaint fails to state a cognizable claim under Section 337 of the Tariff Act, 19 U.S.C. § 1337 (“Section 337”). • A decision...more
The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more