{"id":5505,"date":"2025-07-22T23:02:31","date_gmt":"2025-07-22T23:02:31","guid":{"rendered":"https:\/\/mailitics.com\/index.php\/2025\/07\/22\/sarepta-elevidys-duchenne-fda-transplants-replimmune-melanoma-astrazeneca-tagrisso-sanofi\/"},"modified":"2025-07-22T23:02:31","modified_gmt":"2025-07-22T23:02:31","slug":"sarepta-elevidys-duchenne-fda-transplants-replimmune-melanoma-astrazeneca-tagrisso-sanofi","status":"publish","type":"post","link":"https:\/\/mailitics.com\/index.php\/2025\/07\/22\/sarepta-elevidys-duchenne-fda-transplants-replimmune-melanoma-astrazeneca-tagrisso-sanofi\/","title":{"rendered":"STAT+: Pharmalittle: We\u2019re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more"},"content":{"rendered":"<p>    STAT+: Pharmalittle: We\u2019re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more<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>Good morning everyone, it\u2019s Jason Mast, filling in for Ed again. Here\u2019s a fun fact about drugs, pulled from Anne Harrington\u2019s \u201c<a href=\"https:\/\/bookshop.org\/p\/books\/mind-fixers-psychiatry-s-troubled-search-for-the-biology-of-mental-illness-anne-harrington\/967123\">The Mind Fixers<\/a>,\u201d a fascinating history of psychiatry I\u2019ve recently picked up: After Albert Hoffman synthesized LSD, Sandoz promoted it as a \u201cpsychosis mimicking\u201d drug. Company scientists, along with some psychiatrists, believed the delusions of a good (or bad) trip effectively simulated the experience of having schizophrenia. Clinicians, at least one psychiatrist proposed, might take it themselves to better empathize with their patients. But mostly it was used on volunteers \u2014 from mental hospitals, VA hospitals, universities, prisons \u2014 to model and understand the disease. (Some of this work, yes, received CIA funding.)<\/p>\n<p>The term psychedelic, meaning \u201cmind manifesting,\u201d only emerged in 1956, thanks to author Aldous Huxley. In 1953, he had a mystical experience while taking mescaline and became convinced these drugs had to be rebranded. \u201cIt will give that elixir a bad name if it continues to be associated, in the public mind, with schizophrenia symptoms,\u201d he wrote. \u201cPeople will think they are going mad, when in fact they are beginning, when they take it, to go sane.\u201d And so the \u201860s were born.\u00a0Anyway! Here\u2019s some news. \u2026<\/p>\n<p><strong>Sarepta Therapeutics agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, <\/strong><a href=\"https:\/\/www.statnews.com\/2025\/07\/21\/sarepta-will-stop-shipping-elevidys-fda-duchenne-muscular-dystrophy\/\"><strong>STAT<\/strong><\/a><strong> reports. <\/strong>Sarepta had initially rebuffed a request from the U.S. Food and Drug Administration to suspend shipments, following three deaths from the treatment and a related product. It\u2019s not clear when or how the company will be able to get the drug back on the market, particularly in young children, in whom the therapy has seemed safer.\u00a0<\/p>\n<p><strong>The federal government is launching a reform effort for the U.S. organ transplant system, <\/strong><a href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-begins-organ-transplant-reform-signs-life-found-before-some-retrievals-2025-07-21\/\"><strong>Reuters<\/strong><\/a><strong> tells us. <\/strong>\u00a0The announcement follows a Health and Human Services probe into 351 cases in which organ donation was authorized but not completed, which found 73 patients had shown neurological signs incompatible with organ donation and at least 28 patients may not have been deceased at the time organ procurement was initiated. It also follows New York Times investigations into attempted organ retrieval from donors who showed signs of life, using a procedure called donation after circulatory death, in which donors are not brain dead.\u00a0<\/p>\n<p><a href=\"https:\/\/www.statnews.com\/pharmalot\/2025\/07\/22\/sarepta-elevidys-duchenne-fda-transplants-replimmune-melanoma-astrazeneca-tagrisso-sanofi\/?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    Jason Mast<br \/>\n \t<BR><br \/>\n<BR><\/BR><br \/>\n<a href=\"https:\/\/www.statnews.com\/pharmalot\/2025\/07\/22\/sarepta-elevidys-duchenne-fda-transplants-replimmune-melanoma-astrazeneca-tagrisso-sanofi\/?utm_campaign=rss\">Go to statnews<\/a><br \/>\n \t<BR><br \/>\n <BR><\/BR><\/p>\n","protected":false},"excerpt":{"rendered":"<p>STAT+: Pharmalittle: We\u2019re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more Good morning everyone, it\u2019s Jason Mast, filling in for Ed again. Here\u2019s a fun fact about drugs, pulled from Anne Harrington\u2019s \u201cThe Mind Fixers,\u201d a fascinating history of psychiatry I\u2019ve recently picked up: After Albert Hoffman synthesized LSD, Sandoz [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2176,2312,2153,2152],"tags":[2150],"class_list":["post-5505","post","type-post","status-publish","format-standard","hentry","category-pharma","category-pharmalittle","category-pharmalot","category-stat","tag-statnews"],"_links":{"self":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/5505"}],"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=5505"}],"version-history":[{"count":0,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/5505\/revisions"}],"wp:attachment":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/media?parent=5505"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/categories?post=5505"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/tags?post=5505"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}