{"id":493428,"date":"2024-01-22T09:04:59","date_gmt":"2024-01-22T14:04:59","guid":{"rendered":"https:\/\/platohealth.ai\/investigators-fault-lilly-plant-for-manufacturing-issues\/"},"modified":"2024-01-22T10:31:13","modified_gmt":"2024-01-22T15:31:13","slug":"investigators-fault-lilly-plant-for-manufacturing-issues","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/investigators-fault-lilly-plant-for-manufacturing-issues\/","title":{"rendered":"Investigators fault Lilly plant for manufacturing issues","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"<div><img decoding=\"async\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/investigators-fault-lilly-plant-for-manufacturing-issues.jpg\" class=\"ff-og-image-inserted\"><\/div>\n<p><em>Want to stay on top of the science and politics driving biotech today?&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/signup\/readout\/\">Sign up<\/a>&nbsp;to get our biotech newsletter in your inbox.<\/em><\/p>\n<p>Today, lots of regulatory content! We talk about march-in rights and chastening TikTok influencers for their prescription drug #sponcon.<\/p>\n<div class=\"ad-in-article dfp-ad-midbreaker-wrap\">\n<p class=\"ad-label\">advertisement<\/p>\n<\/div>\n<h2>The need-to-know this morning<\/h2>\n<ul>\n<li><strong>Coherus Biosciences&nbsp;<\/strong><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/investors.coherus.com\/news-releases\/news-release-details\/coherus-announces-agreement-divest-ophthalmology-franchise?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\" data-hs-link-id=\"0\">sold Cimerli<\/a>, a biosimilar version of the eye drug Lucentis, to&nbsp;<strong>Sandoz<\/strong>&nbsp;for $170 million. With the transaction, Coherus said it was exiting the eye disease business to focus on cancer.<\/li>\n<li>Sagimet Biosciences&nbsp;announced&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/ir.sagimet.com\/news-releases\/news-release-details\/sagimet-biosciences-announces-positive-topline-results-phase-2b?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\" data-hs-link-id=\"0\">results from a mid-stage study<\/a>&nbsp;of an experimental treatment for MASH, a progressive liver disease.<\/li>\n<li>The&nbsp;<strong>Genentech unit of Roche<\/strong>&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/ir.acimmune.com\/news-releases\/news-release-details\/ac-immune-regain-global-rights-crenezumab-and-semorinemab?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\" data-hs-link-id=\"0\">returned rights<\/a>&nbsp;to two experimental drugs for Alzheimer\u2019s disease to&nbsp;<strong>AC Immune,&nbsp;<\/strong>following the termination of a development partnership.<\/li>\n<li><strong>Ionis Pharmaceuticals<\/strong>&nbsp;said its injectable treatment called donidalorsen&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/ir.ionispharma.com\/news-releases\/news-release-details\/ionis-announces-positive-topline-results-phase-3-oasis-hae-study?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\" data-hs-link-id=\"0\">reduced the frequency of severe tissue<\/a>&nbsp;swelling \u201cattacks\u201d compared to a placebo in patients with hereditary angioedema. The results achieved the goals of a Phase 3 study, and Ionis plans to submit the drug for regulatory approval.<\/li>\n<li><strong>Autolus Therapeutics<\/strong>&nbsp;said the FDA&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/autolus.gcs-web.com\/news-releases\/news-release-details\/autolus-therapeutics-announces-acceptance-biologics-license?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\" data-hs-link-id=\"0\">accepted its marketing application<\/a>&nbsp;for obe-cel, a personalized CAR-T therapy to treat adult patients with&nbsp;B-cell acute lymphoblastic leukemia. The FDA will render an approval decision on or before Nov. 16.<\/li>\n<\/ul>\n<h2>The pros and cons of march-in rights<\/h2>\n<p>March-in rights are controversial: While some say they can be used to help lower drug prices, others say they are a threat to intellectual property. As STAT\u2019s Ed Silverman&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/2024\/01\/22\/march-in-rights-drug-prices-xtandi-pharma-debate-patents\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\">explains<\/a>, the use of march-in rights would essentially mean that if the government has helped fund research used by a drugmaker, it can require that company to license its patent to someone else \u2014 increasing competition. But the biopharma industry says the exercise of these rights would infringe on profits and, ultimately, intellectual&nbsp;&nbsp;property rights.<\/p>\n<p>\u201cIt\u2019s going to be a problem for small companies, in particular, because they\u2019ll be subject to being shaken down,\u201d said Joseph Allen, executive director of the Bayh-Dole Coalition, a group that represents drugmakers and university technology transfer offices. \u201cIt would be a disaster for innovation and won\u2019t cure the problem of drug prices.\u201d<\/p>\n<p><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/2024\/01\/22\/march-in-rights-drug-prices-xtandi-pharma-debate-patents\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\">Read more.<\/a><\/p>\n<div class=\"ad-in-article dfp-ad-midbreaker2-wrap\">\n<p class=\"ad-label\">advertisement<\/p>\n<\/div>\n<h2>Micro-influencers need stricter regulation<\/h2>\n<p>There\u2019s little regulatory oversight for influencers that promote prescription drugs. Celebrities like Khloe Kardashian and Aly Raisman are getting paid by drugmakers to endorse medications, as are micro-influencers with as few as 1,000 followers on platforms like Instagram and TikTok. They carry a tremendous amount of power, according to a trio of advocates for transparency in medicine, and more supervision is critical.<\/p>\n<p>This is partly because users can develop \u201cparasocial relationships,\u201d which are one-sided connections where they perceive the influencer as a trusted friend. This makes any advertising from micro-influencers even more potent \u2014 and more in need of scrutiny, the authors say.<\/p>\n<p><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/2024\/01\/22\/fda-ftc-tiktok-instagram-influencers-advertising-prescription-drugs\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\">Read more.<\/a><\/p>\n<h2>Novartis chastened by FDA for its TV ad<\/h2>\n<p>The FDA has chastised Novartis for making misleading statements on television about Kisqali, a top-selling breast cancer treatment. Regulators said that an analysis of patient-reported outcomes data showed that Kisqali did not actually help \u201cpreserve quality of life\u201d or ensure that a patient \u201clives well.\u201d<\/p>\n<p>\u201cThe violation is particularly concerning because the overstated representations about Kisqali\u2019s efficacy could lead patients with advanced or metastatic breast cancer\u2026 to believe that Kisquali has been shown to be more effective in treating their condition and symptoms \u2014 with respect to overall survival and quality of life \u2014 than was actually demonstrated,\u201d the FDA wrote about a television ad from Novartis.<\/p>\n<p><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/pharmalot\/2024\/01\/19\/fda-novartis-breast-cancer-tv-advertising\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\">Read more.<\/a><\/p>\n<h2>Investigators fault Lilly plant for manufacturing issues<\/h2>\n<p>Federal investigators have found that an Eli Lilly plant in New Jersey hasn\u2019t maintained or calibrated some of its equipment,&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-fda-finds-new-manufacturing-lapses-eli-lilly-plant-2024-01-19\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\" data-hs-link-id=\"0\">Reuters<\/a>&nbsp;reports.&nbsp;The company has now asked the FDA for \u201cadditional flexibility\u201d specifically to manufacture the migraine medicine Emgality. The drugmaker said that no other products made there were affected; other drugs manufactured at that plant include the diabetes medicine Trulicity and cancer medicines Erbitux and Cyramza.<\/p>\n<p>Lilly now has the highest market capitalization of any biopharma company, having minted money from demand for its obesity and diabetes treatment Mounjaro. But the Indianapolis-based company has received multiple citations for manufacturing issues in its U.S. plants in recent years, Reuters writes. This particular facility, in Branchburg, N.J., has been the subject of a federal probe into poor manufacturing practices and data falsification.<\/p>\n<h2>More reads<\/h2>\n<ul>\n<li>FDA adds \u2018boxed warning\u2019 for Amgen\u2019s bone loss drug Prolia,&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-fda-revises-labeling-amgens-drug-treat-bone-loss-2024-01-19\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\" data-hs-link-id=\"0\">Reuters<\/a><\/li>\n<li>Kyverna accelerates into another FDA fast track following IPO plans,&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.fiercebiotech.com\/biotech\/kyverna-accelerates-fda-fast-track-following-ipo-plans?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\" data-hs-link-id=\"0\">FierceBiotech<\/a><\/li>\n<li>AstraZeneca\u2019s rare blood disorder pill approved in Japan,&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/endpts.com\/astrazenecas-rare-blood-disorder-pill-approved-in-japan\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-8FyhzV-DyfrzO3Sa3M1NTvXjhjay8YHgbxbdQzUlsHd_kEqhWj-kXuxmukr2Y-IcYOOps5\" data-hs-link-id=\"0\">Endpoints<\/a><\/li>\n<\/ul>\n<p><em>Pssst. If you\u2019ve made it to the end of this article, you might be interested in joining this&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/scorecard\/\">secret list<\/a> for an upcoming biotech newsletter. Just some food for thought.<\/em><\/p>\n<ul class=\"plato-post-bottom-links\">\n<li class=\"plato-post-bottom-link-amplifi\">SEO Powered Content &amp; PR Distribution. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.amplifipr.com\">Get Amplified Today.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platodata-network\">PlatoData.Network Vertical Generative Ai. Empower Yourself. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platodata.network\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platoaistream\">PlatoAiStream. Web3 Intelligence. Knowledge Amplified. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoaistream.com\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platoesg\">PlatoESG. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/carbon\/\">Carbon,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/cleantech\/\">CleanTech,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/energy\/\">Energy,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/environment\/\">Environment,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/solar\/\">Solar,<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\/aiwire\/waste-management\/\">Waste Management.<\/a> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/platoesg.com\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platohealth\">PlatoHealth. Biotech and Clinical Trials Intelligence. <a href=\"https:\/\/platohealth.ai\" target=\"_blank\" rel=\"noopener\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-source\"><span>Source:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/2024\/01\/22\/biotech-news-eli-lilly-roche-genentech-coherus-ionis-autolus-ac-immune-march-in-rights\/?utm_campaign=rss\">https:\/\/www.statnews.com\/2024\/01\/22\/biotech-news-eli-lilly-roche-genentech-coherus-ionis-autolus-ac-immune-march-in-rights\/?utm_campaign=rss<\/a><\/li>\n<\/ul>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"excerpt":{"rendered":"<p>Want to stay on top of the science and politics driving biotech today?&nbsp;Sign up&nbsp;to get our biotech newsletter in your inbox. Today, lots of regulatory content! We talk about march-in rights and chastening TikTok influencers for their prescription drug #sponcon. advertisement The need-to-know this morning Coherus Biosciences&nbsp;sold Cimerli, a biosimilar version of the eye drug [&hellip;]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":493431,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[50],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/493428"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=493428"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/493428\/revisions"}],"predecessor-version":[{"id":493430,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/493428\/revisions\/493430"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/493431"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=493428"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=493428"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=493428"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}