{"id":92416,"date":"2026-05-07T14:52:45","date_gmt":"2026-05-07T14:52:45","guid":{"rendered":"https:\/\/diyhaven858.wasmer.app\/index.php\/pharmalittle-were-reading-about-sanofi-and-an-fda-voucher-fda-rethinking-a-rejection-and-more\/"},"modified":"2026-05-07T14:52:45","modified_gmt":"2026-05-07T14:52:45","slug":"pharmalittle-were-reading-about-sanofi-and-an-fda-voucher-fda-rethinking-a-rejection-and-more","status":"publish","type":"post","link":"https:\/\/diyhaven858.wasmer.app\/index.php\/pharmalittle-were-reading-about-sanofi-and-an-fda-voucher-fda-rethinking-a-rejection-and-more\/","title":{"rendered":"Pharmalittle: We&#8217;re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div>\n<p>Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel\u2019s. Yes, this is a real thing. And remember, a prescription is not required. So no need to mess with rebates, coupons, or TrumpRx. Meanwhile, here are a few items of interest. Hope you have a smashing day and conquer the world. And of course, do stay in touch. We appreciate feedback, criticism and tips. \u2026<\/p>\n<p><strong>Sanofi asked the U.S. Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of FDA Commissioner Marty Makary\u2019s new speedy review program<\/strong>, STAT reports. The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth H\u00f8eg disagreed with a staff decision to approve the drug. The agency missed its April 21 goal date to deliver a decision to Sanofi. Such decisions are typically made by career scientists. It is rare for a center director to become involved in scientific review of a single drug, and particularly a political appointee like H\u00f8eg. Makary recently said that he stands behind review teams, and that \u201cdisaster\u201d occurs whenever political leaders overrule scientific staff.\u00a0<\/p>\n<p><strong>An experimental drug from Revolution Medicines\u00a0that nearly \u200bdoubled survival time for patients with advanced pancreas cancer in clinical trials comes with a high rate \u200cof mostly low-grade side effects<\/strong>, Reuters tells us. A report by researchers from a first-in-human trial of daraxonrasib is the first peer-reviewed paper to show safety data for what analysts say\u00a0could become the next standard of care for previously treated metastatic pancreatic cancer. Among the 168 patients with previously treated pancreatic ductal adenocarcinoma who received daraxonrasib in the early trial, treatment-related adverse side effects \u200bof any grade occurred in 96%, while severe or life-threatening events were reported in 30%.<\/p>\n<div class=\"restricted-content-breaker article\" aria-labelledby=\"restricted-story-heading\" aria-describedby=\"restricted-story-description\" checked=\"false\">\n<div class=\"restricted-content-breaker-bar\">\n<p class=\"restricted-text\">STAT+ Exclusive Story<\/p>\n<p class=\"restricted-login\">Already have an account? 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Log in<\/p>\n<div class=\"restricted-content-breaker-cards\">\n<div class=\"slider-container\" aria-label=\"Subscription plan toggle\">\n\t\t\t\t\t\t<button type=\"button\" class=\"individual\" aria-pressed=\"false\">Individual plans<\/button><\/p>\n<p>\t\t\t\t\t\t<button type=\"button\" class=\"group\" aria-pressed=\"false\">Group plans<\/button>\n\t\t\t\t\t<\/div>\n<\/p><\/div>\n<p>\t\t\t\tView All Plans\n\t\t\t<\/p><\/div>\n<\/p><\/div>\n<div class=\"restricted-message-breaker\">\n<div class=\"restricted-content-wrapper\">\n<div class=\"restricted-content-message\">\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\tSubscribe\n\t\t\t\t\t\t\t\t\t<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<p><br \/>\n<br \/><<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel\u2019s. Yes, this is a real thing. And remember, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":92423,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_daextam_enable_autolinks":"","jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[2],"tags":[],"class_list":["post-92416","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/diyhaven858.wasmer.app\/wp-content\/uploads\/2026\/05\/1778166169_PHARMALOT_LITTLE-copy-1024x576.jpg","jetpack_sharing_enabled":true,"jetpack-related-posts":[],"_links":{"self":[{"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/posts\/92416","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/comments?post=92416"}],"version-history":[{"count":0,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/posts\/92416\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/media\/92423"}],"wp:attachment":[{"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/media?parent=92416"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/categories?post=92416"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/tags?post=92416"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}