The pharmaceutical industry's top lobbying group is getting a new leader. PhRMA said former Virginia congressman Eric Cantor will become president and CEO on Nov. 9, succeeding Steve Ubl, who has led the group since 2015 and will stay on as a strategic adviser through Jan. 15. PhRMA noted Cantor's role in the 21st Century Cures Act and his work on Medicare Part D legislation.
In regulatory news, Pierre Fabre Laboratories has resubmitted Ebvallo to the FDA after the agency rejected the cell therapy twice, most recently in January. Originally developed by Atara Biotherapeutics, Ebvallo has been available in Europe since late 2022 for a lethal complication of Epstein-Barr virus infections. The new application is built around updated data from a single-arm trial, expanded access programs, and European commercial use.
Mirum Pharmaceuticals reported positive results from the first of two Phase 3 trials for brelovitug in chronic hepatitis D, with viral suppression seen in 56% of low-dose and 45% of high-dose recipients after 24 weeks. Mirum also received FDA approval for zilurgisertib, sold as Atebrioz, for the ultra-rare bone disease FOP in adults and children 12 and older. Separately, the FDA approved AbbVie's Juvmo, a first-in-class Parkinson's disease treatment that targets two dopamine receptors. With only one source, there are no differing reports to reconcile.