Shire Shrugs Off Lifitegrast CRL; Launch Expected In 2016
This article was originally published in Scrip
An early warning, and preparation, helped Shire PLC to blunt the impact of a US FDA complete response letter for its dry-eye candidate lifitegrast.
You may also be interested in...
Plus deals involving LegoChem/Pyxix, Biohaven/Sosei Heptares, Kyowa Kirin/Helsinn, Dr. Reddy’s/Glenmark, Eisai/Wren, KoBioLabs/Kolmar Korea, Y-Biologics/Pierre Fabre, Generex/Chinese consortium.
Strong top-line efficacy in pyruvate kinase deficiency patients who don’t receive regular transfusions looks approvable, analysts say, but Agios will await data in regularly transfused patients.
With its US/Mexico Phase III trial delayed due to manufacturing questions, Novavax has aligned its UK study with FDA guidance. It hopes for interim data from that study during Q1 2021.