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Morning! Today, we preview a contentious generic drug dispute that may end up at the Supreme Court, discuss how the FDA’s new stance on vaccines could impact RSV shots, and more.
‘Skinny labels’ may face a Supreme Court reckoning
In a high stakes test for drug competition, the U.S. solicitor general is urging the Supreme Court to review a case that could determine whether “skinny labels” — a long-standing Hatch-Waxman carve-out allowing generics to sidestep patented indications — can survive. The dispute centers on a bid by Amarin, which markets the heart drug Vascepa, to block a generic made by Hikma Pharmaceuticals, STAT’s Ed Silverman writes. Hikma excluded Amarin’s patented cardiovascular-risk use from its skinny label.
Continue to STAT+ to read the full story…
STAT Pharma: The science and business of new drug development
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