{"id":5602,"date":"2025-07-25T23:02:24","date_gmt":"2025-07-25T23:02:24","guid":{"rendered":"https:\/\/mailitics.com\/index.php\/2025\/07\/25\/biotech-news-sarepta-eli-lilly-ssri-effects-nih-bristol-meyers-squibb-the-readout\/"},"modified":"2025-07-25T23:02:24","modified_gmt":"2025-07-25T23:02:24","slug":"biotech-news-sarepta-eli-lilly-ssri-effects-nih-bristol-meyers-squibb-the-readout","status":"publish","type":"post","link":"https:\/\/mailitics.com\/index.php\/2025\/07\/25\/biotech-news-sarepta-eli-lilly-ssri-effects-nih-bristol-meyers-squibb-the-readout\/","title":{"rendered":"STAT+: FDA panel stirs backlash for SSRI use during pregnancy"},"content":{"rendered":"<p>    STAT+: FDA panel stirs backlash for SSRI use during pregnancy<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 discuss how Duchenne patients and their families are responding to the shelving of Sarepta Therapeutics\u2019 gene therapy, see an FDA panel made up largely of SSRI skeptics lambast their use in pregnancy, and more.<\/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>European regulators said\u00a0<strong>Sarepta Therapeutics\u2019<\/strong> Duchenne muscular dystrophy gene therapy <a href=\"https:\/\/www.statnews.com\/2025\/07\/25\/elevidys-duchenne-europe-gene-therapy-sarepta-roche\/\" rel=\"noopener\">should not be approved<\/a>, further imperiling the future of the treatment, which\u00a0is also facing increasing scrutiny in the U.S. Roche has commercial rights to the gene therapy, called Elevidys, in Europe and other countries.\u00a0<\/li>\n<li>European regulators said <strong>Eli Lilly\u2019s<\/strong> Alzheimer\u2019s treatment Kisunla <a href=\"https:\/\/www.statnews.com\/2025\/07\/25\/europe-eli-lilly-kisunla-alzheimers-aria-approval\/\" rel=\"noopener\">should be approved<\/a> for a select group of patients, changing course from an initial recommendation to reject the drug.\u00a0<\/li>\n<li>\n<strong>Bristol Myers Squibb<\/strong> <a href=\"https:\/\/news.bms.com\/news\/corporate-financial\/2025\/Cristian-Massacesi-M-D--Joins-Bristol-Myers-Squibb-as-Executive-Vice-President-Chief-Medical-Officer-and-Head-of-Development\/default.aspx\" rel=\"noopener\">named<\/a> Cristian Massacesi as its new chief medical officer. Massacesi is a phyisican and most recently served as chief medical officer at AstraZeneca and its Alexion unit. He replaces Samit Hirawat, who served as Bristol\u2019s CMO for the past six years.\u00a0<\/li>\n<\/ul>\n<h2 class=\"wp-block-heading\" id=\"h-families-devastated-after-fda-halts-sarepta-gene-therapy\">Families devastated after FDA halts Sarepta gene therapy<\/h2>\n<p>Families of boys with Duchenne muscular dystrophy were devastated\u00a0when the Food and Drug Administration asked Sarepta Therapeutics\u00a0to halt shipments of its gene therapy, Elevidys, citing safety concerns\u00a0\u2014 and the company subsequently agreed earlier this week. Parents who had fought for months to secure access are now stuck in limbo, with appointments abruptly canceled and little communication from regulators, STAT\u2019s Jason Mast reports.<\/p>\n<p><a href=\"https:\/\/www.statnews.com\/2025\/07\/25\/biotech-news-sarepta-eli-lilly-ssri-effects-nih-bristol-meyers-squibb-the-readout\/?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\/07\/25\/biotech-news-sarepta-eli-lilly-ssri-effects-nih-bristol-meyers-squibb-the-readout\/?utm_campaign=rss\">Go to statnews<\/a><br \/>\n \t<BR><br \/>\n <BR><\/BR><\/p>\n","protected":false},"excerpt":{"rendered":"<p>STAT+: FDA panel stirs backlash for SSRI use during pregnancy 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 discuss how Duchenne patients and their families are responding to the shelving of Sarepta Therapeutics\u2019 gene therapy, see an FDA panel [&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-5602","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\/5602"}],"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=5602"}],"version-history":[{"count":0,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/5602\/revisions"}],"wp:attachment":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/media?parent=5602"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/categories?post=5602"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/tags?post=5602"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}