UCB Pharma was delirious with glee when it managed to launch its new TNF inhibitor Cimzia for Crohn's diseaseÂ just 48 hours after the FDA gave its blessing. As In Vivo notes, the joy is understandable: The agency's approval surprised skeptics and boosted shares by 20 percent immediately.
But the quick launch is significant for other reasons, too. Though they've become routine, it wasn't so long ago that the FDA was a mysterious, opaque agency, a sort of oracle from which approvals or denials might issue at any time. Then came user fees and deadlines, allowing drugmakers to prep their launches as the agency's action date approached, saving valuable patent-coverage time. Now, though, the understaffedÂ agency has started missing more deadlines, and, infected with excess caution, second-guessing itself. So predictability is starting to suffer--and so might drugmakers' ability to plan ahead.
Not to mention new regulatory requirements, which dogged CimziaÂ through the approval process. But we'll let In Vivo tell the rest of that story.
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