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The U.S. Court of Appeals for the Seventh Circuit grappled with whether so-called patent thickets and certain global patent settlements constitute antitrust behavior as it heard arguments Feb. 25 in UFCW Local 1500 Welfare Fund v. Abbvie Inc.
As expected, the FDA granted an approval for Amondys 45 (casimersen), a new Duchenne muscular dystrophy (DMD) therapy developed by Sarepta Therapeutics Inc.
Briefing documents released by the FDA related to the Vaccines and Related Products Advisory Committee meeting slated for Friday suggest that the COVID-19 vaccine from Johnson & Johnson (J&J) will sail smoothly to an emergency use authorization. “A century ago, [J&J] played a leading role in combatting the 1918 flu pandemic,” said Richard Nettles, the Whitehouse Station, N.J.-based company’s vice president of medical affairs in testimony Feb. 23 before the House Energy and Commerce Subcommittee on Oversight. “Our history of confronting global health care challenges continues to the present day, including with the European approval of our Ebola vaccine last year,” he added, saying the company “brought this same approach to the COVID-19 pandemic.”