Drug Fix: CBER Director Candidate Emerges, US FDA Promotes Leucovorin Pathway

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs discuss potential takeaways from the Trump Administration floating ophthalmologist, entrepreneur and Fox News contributor Houman David Hemmati as the next potential Center for Biologics Evaluation and Research director (:34), as well as the appointment of US Food and Drug Administration Principal Deputy Commissioner Sara Brenner to a position in the Health and Human Services Department (8:30). They also consider whether the FDA’s approach to adding an indication for leucovorin could be more widely used in the rare disease space (14:08) and new guidance for the agency’s plausible mechanism pathway (22:50).   #pharma #business   More On These Topics From The Pink Sheet   New CBER Director Candidate Could Signal Industry Cred Important Again: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/new-cber-director-candidate-could-signal-industry-cred-important-again-ZDJ4ECR4QNDBPBRTKNHD2B5R24/   US FDA’s Principal Deputy Commissioner Moving To HHS As Senior Counselor For Public Health: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-principal-deputy-commissioner-moving-to-hhs-as-senior-counselor-for-public-health-C64ZB6WRTNEJ7MC7I3ZY3KNP6I/   US FDA’s Literature-Based Leucovorin Approval May Offer A Rare Disease Template: https://insights.citeline.com/pink-sheet/rare-diseases/us-fdas-literature-based-leucovorin-approval-may-offer-a-rare-disease-template-Z34IYMFF35ENVJXV4N4ZT4GG6Q/   US FDA To Clarify Plausible Mechanism Framework With Genome Editing Guidances, Workshop: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-to-clarify-plausible-mechanism-framework-with-genome-editing-guidances-workshop-QTWKR3NCXJFJNKCOE3BTBSW4K4/