{"id":611900,"date":"2026-07-30T15:54:12","date_gmt":"2026-07-30T15:54:12","guid":{"rendered":"https:\/\/www.europesays.com\/ie\/611900\/"},"modified":"2026-07-30T15:54:12","modified_gmt":"2026-07-30T15:54:12","slug":"pharmalittle-fda-panel-nixed-duchenne-drug-hims-hers-sued-stat","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ie\/611900\/","title":{"rendered":"Pharmalittle: FDA panel nixed Duchenne drug, Hims &#038; Hers sued| STAT"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Top of the morning to you, and a fine one it is. Skies are gray but rain is not expected on the Pharmalot campus today, making it possible for the official mascots to eat breakfast on the deck and take long, luxurious naps. As for us, we are firing up the trusty kettle to make another cuppa stimulation. Our choice today is English breakfast, another old standby from the pantry. Please feel free to join us. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. \u2026<\/p>\n<p class=\"wp-block-paragraph\"><strong>A U.S. Food and Drug Administration advisory panel voted 9-to-3 against effectiveness data for a Capricor Therapeutics treatment for Duchenne muscular dystrophy<\/strong>, <a href=\"https:\/\/www.statnews.com\/2026\/07\/29\/capricor-therapeutics-deramiocel-fda-review-meeting-live-blog\/\" id=\"https:\/\/www.statnews.com\/2026\/07\/29\/capricor-therapeutics-deramiocel-fda-review-meeting-live-blog\/\" rel=\"nofollow noopener\" target=\"_blank\">STAT<\/a> tells us. The key question centered on whether the drug had shown it could treat Duchenne-related cardiomyopathy. Last year, the agency declined to approve\u00a0\u200bthe therapy \u2060and sought additional data after saying the treatment did not meet efficacy requirements. During the meeting, the FDA spent a good deal of time  calling out Capricor, saying it made major changes to the study\u2019s statistical analysis plan that degraded the robustness of the data and made even seemingly positive outcomes hard to interpret.<\/p>\n<p class=\"wp-block-paragraph\"><strong>The U.S. Federal Trade Commission\u00a0<a href=\"https:\/\/storage.courtlistener.com\/recap\/gov.uscourts.cand.475189\/gov.uscourts.cand.475189.1.0.pdf\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">sued<\/a>\u00a0Hims &amp; Hers, continuing a pattern of action against the business practices and use of consumer health data by digital health companies<\/strong>, <a href=\"https:\/\/www.statnews.com\/2026\/07\/29\/ftc-lawsuit-hims-alleging-deceptive-business-practices\/\" id=\"https:\/\/www.statnews.com\/2026\/07\/29\/ftc-lawsuit-hims-alleging-deceptive-business-practices\/\" rel=\"nofollow noopener\" target=\"_blank\">STAT<\/a> notes. The agency, along with Utah and California, alleged that Hims misled consumers about sharing sensitive health information with third parties, and that the company is not clear when consumers fill out medical histories and are signing up for a subscription that continually renews and bills them for medicine. Patients also are not given an opportunity to review a provider\u2019s recommended treatment or provide consent. The FTC also alleges the site makes it difficult for users to cancel their subscriptions.\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\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t<img decoding=\"async\" class=\"restricted-content-breaker-bg\" src=\"https:\/\/www.europesays.com\/ie\/wp-content\/uploads\/2026\/07\/1785426852_588_stat-plus-breaker-bg.png\" alt=\"STAT+\"\/><\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" rel=\"nofollow noopener\" target=\"_blank\"><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\" rel=\"nofollow noopener\" target=\"_blank\">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\" rel=\"nofollow noopener\" target=\"_blank\">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\" rel=\"nofollow noopener\" target=\"_blank\">Subscribe<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Top of the morning to you, and a fine one it is. Skies are gray but rain is&hellip;\n","protected":false},"author":2,"featured_media":611901,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[274],"tags":[18,135,19,17,462,101516,2850],"class_list":["post-611900","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-eire","tag-health","tag-ie","tag-ireland","tag-medication","tag-pharmalittle","tag-stat"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ie\/117009743069321728","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/611900","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/comments?post=611900"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/611900\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media\/611901"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media?parent=611900"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/categories?post=611900"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/tags?post=611900"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}