{"id":8340,"date":"2025-11-13T23:02:20","date_gmt":"2025-11-13T23:02:20","guid":{"rendered":"https:\/\/mailitics.com\/index.php\/2025\/11\/13\/biotech-news-fda-outlines-gene-editing-pathway\/"},"modified":"2025-11-13T23:02:20","modified_gmt":"2025-11-13T23:02:20","slug":"biotech-news-fda-outlines-gene-editing-pathway","status":"publish","type":"post","link":"https:\/\/mailitics.com\/index.php\/2025\/11\/13\/biotech-news-fda-outlines-gene-editing-pathway\/","title":{"rendered":"STAT+: Makary, Prasad outline pathway for bespoke gene therapy"},"content":{"rendered":"<p>    STAT+: Makary, Prasad outline pathway for bespoke gene therapy<br \/>\n \t<BR><br \/>\n<BR><\/BR><br \/>\n    <!-- no image --><br \/>\n \t<BR><br \/>\n<BR><\/BR><\/p>\n<div>\n<p><em>Want to stay on top of the science and politics driving biotech today?\u00a0<a href=\"https:\/\/www.statnews.com\/signup\/readout\/\">Sign up<\/a>\u00a0to get our biotech newsletter in your inbox.<\/em><\/p>\n<p>Morning. Today, we learn AbbVie has ended its partnership with Calico, the FDA outlines how bespoke gene-editing treatments can make it through the regulatory pipeline, and more.\u00a0<\/p>\n<h2 class=\"wp-block-heading\" id=\"h-the-need-to-know-this-morning\">The need-to-know this morning<\/h2>\n<ul class=\"wp-block-list\">\n<li>\n<strong>Day One Pharmaceuticals<\/strong> is <a href=\"https:\/\/ir.mersana.com\/news-releases\/news-release-details\/day-one-biopharmaceuticals-acquire-mersana-therapeutics\" rel=\"noopener\">acquiring<\/a> <strong>Mersana Therapeutics<\/strong> in a deal valued at $129 million, and up to $285 million if certain post-close milestones are met. Day One markets a treatment for pediatric brain tumors, while Mersana is developing antibody-drug conjugates for cancer.\u00a0<\/li>\n<\/ul>\n<h2 class=\"wp-block-heading\" id=\"h-fda-outlines-pathway-for-bespoke-gene-editing\">FDA outlines pathway for bespoke gene editing<\/h2>\n<p>FDA Commissioner Marty Makary and biologics chief Vinay Prasad have sketched out the agency\u2019s first real blueprint for approving personalized gene-editing therapies, STAT\u2019s Jason Mast reports. It\u2019s a shift that could transform last year\u2019s one-off miracle for \u201cBaby KJ\u201d into a scalable model for ultra-rare diseases.<\/p>\n<p><a href=\"https:\/\/www.statnews.com\/2025\/11\/13\/biotech-news-fda-outlines-gene-editing-pathway\/?utm_campaign=rss\">Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n<p> \t<BR><br \/>\n <BR><\/BR><br \/>\n    Meghana Keshavan<br \/>\n \t<BR><br \/>\n<BR><\/BR><br \/>\n<a href=\"https:\/\/www.statnews.com\/2025\/11\/13\/biotech-news-fda-outlines-gene-editing-pathway\/?utm_campaign=rss\">Go to statnews<\/a><br \/>\n \t<BR><br \/>\n <BR><\/BR><\/p>\n","protected":false},"excerpt":{"rendered":"<p>STAT+: Makary, Prasad outline pathway for bespoke gene therapy Want to stay on top of the science and politics driving biotech today?\u00a0Sign up\u00a0to get our biotech newsletter in your inbox. Morning. Today, we learn AbbVie has ended its partnership with Calico, the FDA outlines how bespoke gene-editing treatments can make it through the regulatory pipeline, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2194,2154,58,2208,2209,2176,858,2207],"tags":[2150],"class_list":["post-8340","post","type-post","status-publish","format-standard","hentry","category-biotech","category-biotechnology","category-business","category-drug-development","category-drug-prices","category-pharma","category-research","category-the-readout","tag-statnews"],"_links":{"self":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/8340"}],"collection":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/comments?post=8340"}],"version-history":[{"count":0,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/8340\/revisions"}],"wp:attachment":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/media?parent=8340"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/categories?post=8340"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/tags?post=8340"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}