{"id":72,"date":"2025-06-20T19:53:33","date_gmt":"2025-06-20T19:53:33","guid":{"rendered":"https:\/\/www.europesays.com\/us\/72\/"},"modified":"2025-06-20T19:53:33","modified_gmt":"2025-06-20T19:53:33","slug":"fda-ouster-of-top-gene-therapy-official-reveals-internal-tensions","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/72\/","title":{"rendered":"FDA ouster of top gene therapy official reveals internal tensions"},"content":{"rendered":"<p class=\"author-bio\">Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast <a href=\"https:\/\/www.statnews.com\/category\/readout-loud\/\" target=\"_blank\" rel=\"noopener\">The Readout Loud<\/a> and author of the newsletter <a href=\"https:\/\/www.statnews.com\/signup\/scorecard\/\" target=\"_blank\" rel=\"noopener\">Adam\u2019s Biotech Scorecard.<\/a> You can reach Adam on Signal at stataf.54.<\/p>\n<p>The ouster of the Food and Drug Administration\u2019s chief regulator of cell and gene therapies earlier this week came immediately after a disagreement with her boss over the review of a cell therapy for Duchenne muscular dystrophy, STAT has learned.\u00a0<\/p>\n<p>The regulator, Nicole Verdun, had scheduled an advisory committee meeting to review the therapy developed by Capricor Therapeutics. But Vinay Prasad, director of the FDA\u2019s Center for Biologics Evaluation and Research, was skeptical of the treatment and decided unilaterally to cancel the meeting, according to a person familiar with the matter.\u00a0\u00a0<\/p>\n<p>At the same time, there had been long-simmering tensions over Verdun\u2019s management style, according to others familiar with the matter, raising further questions about the precise reason she was placed on leave.\u00a0<\/p>\n<p class=\"restricted-text\">STAT+ Exclusive Story<\/p>\n<p class=\"restricted-login\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta\" target=\"_blank\" rel=\"noopener\">Log in<\/a><\/p>\n<p>\t\t\t<img decoding=\"async\" class=\"restricted-content-breaker-bg\" src=\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2025\/06\/stat-plus-breaker-bg.png\" alt=\"STAT+\"\/><\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" target=\"_blank\" rel=\"noopener\"><br \/>\n\t\t\t\t\t\t<img decoding=\"async\" class=\"stat-plus-logo\" src=\"https:\/\/www.statnews.com\/wp-content\/themes\/stat\/images\/stat-plus-logo-white.svg\" alt=\"STAT+\"\/><br \/>\n\t\t\t\t\t<\/a><\/p>\n<p>\t\t\t\tThis article is exclusive to STAT+ subscribers<br \/>\n\t\t\t\tUnlock this article \u2014 plus in-depth analysis, newsletters, premium events, and news alerts.<\/p>\n<p class=\"restricted-content-breaker-wrapper-cta mobile\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta mobile\" target=\"_blank\" rel=\"noopener\">Log in<\/a><\/p>\n<p>\t\t\t\t\t\tIndividual plans<\/p>\n<p>\t\t\t\t\t\tGroup plans<\/p>\n<p>\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button view-all\" data-stat-paywall-cta=\"breaker view all plans\" aria-label=\"View All Plans\" target=\"_blank\" rel=\"noopener\">View All Plans<\/a><\/p>\n<p class=\"restricted-content-text\">\n\t\t\t\t\t\tTo read the rest of this story subscribe to STAT+.\t\t\t\t\t<\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button restricted-button\" data-stat-paywall-cta=\"breaker subscribe cta 1\" target=\"_blank\" rel=\"noopener\">Subscribe<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall&hellip;\n","protected":false},"author":3,"featured_media":73,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[150,64,151,152,153,154,67,132,68],"class_list":{"0":"post-72","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-business","8":"tag-biotechnology","9":"tag-business","10":"tag-fda","11":"tag-pharmaceuticals","12":"tag-policy","13":"tag-stat","14":"tag-united-states","15":"tag-unitedstates","16":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/114717445525196542","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/72","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=72"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/72\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/73"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=72"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=72"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=72"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}