{"id":606541,"date":"2024-06-05T09:18:44","date_gmt":"2024-06-05T13:18:44","guid":{"rendered":"https:\/\/platohealth.ai\/testing-begins-for-a-new-form-of-prep\/"},"modified":"2024-06-05T14:17:34","modified_gmt":"2024-06-05T18:17:34","slug":"testing-begins-for-a-new-form-of-prep","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/testing-begins-for-a-new-form-of-prep\/","title":{"rendered":"Testing begins for a new form of PrEP","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"<div><img decoding=\"async\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/06\/testing-begins-for-a-new-form-of-prep.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>Good morning. Jason Mast here filling in for Elaine. We\u2019ve got a dramatic vote on psychedelic therapy, record drug shortages, bad (maybe?) news for Biomarin, and a new kind of PrEP.<\/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>Eli Lilly&nbsp;Chief Financial Officer Anat Ashkenazi&nbsp;is&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/investor.lilly.com\/news-releases\/news-release-details\/lilly-announces-departure-anat-ashkenazi-chief-financial-officer?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\" data-hs-link-id=\"0\">leaving the company<\/a>&nbsp;for a job outside the pharmaceutical industry, Lilly announced. Askenazi is&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/abc.xyz\/2024-0605\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\" data-hs-link-id=\"0\">joining<\/a>&nbsp;Alphabet&nbsp;and&nbsp;Google&nbsp;as its new CFO. A search for a new CFO at Lilly is underway.<\/li>\n<\/ul>\n<h2>FDA panel recommends against approving MDMA-assisted therapy<\/h2>\n<p>An advisory committee yesterday voted overwhelmingly against both questions put to it by the Food and Drug Administration on MDMA-assisted therapy, effectively recommending against what would be the first approval of a psychedelic drug. The FDA doesn\u2019t have to follow the recommendations of advisory panels but generally does.<\/p>\n<p>The vote is a substantial blow to Lykos, the company that brought the application, and to the broader movement to develop psychedelics into FDA-approved treatments for various mental health conditions. Over the last decade, investors have poured hundreds of millions of dollars into biotechs promising to turn molecules like psilocybin, DMT, ibogaine, and LSD into drugs for conditions such as depression, anorexia, and addiction. MDMA was the first to go before the FDA.<\/p>\n<p>Lykos\u2019 data seemed promising: In one study, 67% of patients who received MDMA no longer met PTSD diagnostic criteria, compared to 32% of placebo patients. And the effort won support among many veterans, who emphasized the lack of alternatives. But the company faced questions about functional unblinding \u2014 participants could generally figure out if they received a psychedelic \u2014 and accusations it suppressed safety concerns, such as suicidal ideation, along with concerns about how the therapy would be administered.<\/p>\n<div class=\"ad-in-article dfp-ad-midbreaker2-wrap\">\n<p class=\"ad-label\">advertisement<\/p>\n<\/div>\n<p><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/2024\/06\/04\/fda-advisory-panel-mdma-therapy-ptsd\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\">Read more<\/a>.<\/p>\n<h2>AstraZeneca is Real Madrid, and other ASCO takeaways<\/h2>\n<p>Our triumvirate of cancer correspondents boarded flights yesterday back from Chicago. Some top takeaways from the oncology confab:<\/p>\n<ul>\n<li>\u201cAstraZeneca is the Real Madrid of ASCO. Six plenary podiums in a row.\u201d<\/li>\n<li>\u201cIf we\u2019re talking about this ASCO five years from now, it will probably be because of the CAR-T results in liver cancer from AstraZeneca and AbelZeta.\u201d<\/li>\n<li>\u201cA lot of chatter about finding better ways to scale back treatments when possible \u2014 one of the core tenets in oncology.\u201d<\/li>\n<\/ul>\n<p><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/2024\/06\/04\/asco-takeaways-cancer-care-astrazeneca-car-t-china-data\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\">And much more<\/a>.<\/p>\n<h2>Drug shortages reach record high<\/h2>\n<p>U.S. drug shortages are growing longer and more frequent, according to a new report from U.S. Pharmacopeia, an independent organization that develops standards for medicines. The number of drug shortages has increased over the last decade, while an average shortage now lasts more than three years, compared to two years in 2020. Of 125 drugs in short supply, 27 had been that way for over five years.<\/p>\n<p>A key driver is drugs that are actually too cheap. Most medicines in shortage less than $5, the report found. Low margins for generics drive out manufacturers. If one of the remaining producers then experiences a quality control issue, drugs can become scarce.<\/p>\n<p>Possible solutions include having the U.S. government provide incentives for manufacturers to upgrade facilities and hospitals to create so-called buffer inventories, while also paying bonuses to hospitals and doctors that employ contracting practices that help support sustainable supply. Read more from&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/pharmalot\/2024\/06\/04\/shortages-medicines-drugs-hospitals-manufacturing-cancer-adhd-gpo\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\">Ed Silverman<\/a>.<\/p>\n<h2>Biomarin suffers another setback, maybe<\/h2>\n<p>New Biomarin CEO Alexander Hardy set a clear priority in his first public presentation in January: expanding the market for Voxzogo, its drug for achondroplasia, the most common form of dwarfism. Voxzogo was particularly vital because Roctavian, a hemophilia gene therapy Hardy\u2019s predecessor spent years hyping, was \u2014 and is \u2014 facing a <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/2024\/03\/13\/hemophilia-treatment-gene-therapy-use-of-hemgenix-roctavian\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\">catastrophically<\/a>&nbsp;bad launch.<\/p>\n<p>So it wasn\u2019t good news yesterday when a competitor, BridgeBio, announced data suggesting its own experimental pill may be more effective than Voxzogo. A \u201csubstantial headwind to BioMarin\u2019s growth in the long-term,\u201d Baird analyst Jack Allen wrote.<\/p>\n<p>Nevertheless, Biomarin\u2019s shares rose about 3.5% yesterday. That seems to reflect two things: Investors already baked competitive threats into Biomarin\u2019s stock price, which had fallen nearly 30% from the start of 2023. And being first-to-market has its perks. Stifels analyst Paul Matteis wrote last month that by the time BridgeBio\u2019s drug reaches market \u2014 likely 2027 \u2014 Voxzogo will likely be standard-of-care for young achondroplasia patients and up for approval in hypochondroplasia, another form of dwarfism.<\/p>\n<h2>Testing begins for a new form of PrEP<\/h2>\n<p>The NIH&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.niaid.nih.gov\/news-events\/us-clinical-trials-begin-twice-yearly-hiv-prevention-injection?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\" data-hs-link-id=\"0\">said<\/a>&nbsp;yesterday it began two trials to see whether a new Gilead antiviral can prevent HIV infections with just one injection every six months. The results, though not expected until 2027 and 2028, could transform HIV prevention.<\/p>\n<p>Although oral prophylaxis, called PrEP, has been available since 2012, it has gone vastly underused, because of cost and other barriers, as well as the difficulty for many of taking a pill every single day. Given the struggles the HIV vaccine field has faced, long-acting PrEP marks the best near-term hope for providing individuals with extended protection. A once-every-eight week shot was approved in 2021, although global access has been a&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/pharmalot\/2022\/03\/04\/glaxo-viiv-hiv-aids-prep-license\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\">struggle<\/a>. Once-a-year shots are in early&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.science.org\/content\/article\/anthony-fauci-becoming-devil-and-warning-his-successor?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\" data-hs-link-id=\"0\">development<\/a>.<\/p>\n<h2>More reads<\/h2>\n<ul>\n<li>U.K. drug pricing regulator NICE endorses Eli Lilly\u2019s Obesity drug Zepbound, with a catch,&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.fiercepharma.com\/pharma\/lilly-wins-nice-endorsement-tirzepatide-obesity-catch?itm_source=parsely-api&amp;utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\" data-hs-link-id=\"0\">Fierce Pharma<\/a><\/li>\n<li>Medicare Advantage plan\u2019s quality ratings were incorrectly calculated by government, judge rules,&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.statnews.com\/2024\/06\/04\/medicare-advantage-scan-health-star-rating-incorrect-judge-rules\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\">STAT<\/a><\/li>\n<li>Novo Holdings\u2019 head of Asia on investing in \u2018China for China,\u2019 and staying out of biotech (for now),&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/endpts.com\/novo-holdings-head-of-asia-on-investing-in-china-for-china-and-staying-out-of-biotech-for-now\/?utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\" data-hs-link-id=\"0\">Endpoints<\/a><\/li>\n<li>Startup brings new hope to the pursuit of reviving frozen bodies,&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.bloomberg.com\/news\/articles\/2024-06-03\/cryogenic-freezing-finds-new-hope-from-cradle-healthcare?srnd=businessweek-v2&amp;embedded-checkout=true&amp;utm_campaign=the_readout&amp;utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz-_6cAfqW-cabhr_i7iJF69TIOErKbgLYyrsPH1N5t9Kn8sBkk4nOlaCWsxNeY7FOqNCCVQR\" data-hs-link-id=\"0\">Bloomberg<\/a><\/li>\n<\/ul>\n<div id=\"1717598450.520819\" class=\"c-virtual_list__item\" role=\"listitem\" data-qa=\"virtual-list-item\" data-item-key=\"1717598450.520819\">\n<div class=\"c-message_kit__background c-message_kit__background--hovered p-message_pane_message__message c-message_kit__message\" role=\"presentation\" data-qa=\"message_container\" data-qa-unprocessed=\"false\" data-qa-placeholder=\"false\">\n<div class=\"c-message_kit__hover c-message_kit__hover--hovered\" role=\"document\" data-qa-hover=\"true\">\n<div class=\"c-message_kit__actions c-message_kit__actions--default\">\n<div class=\"c-message_kit__gutter\">\n<div class=\"c-message_kit__gutter__right\" role=\"presentation\" data-qa=\"message_content\">\n<div class=\"c-message_kit__blocks c-message_kit__blocks--rich_text\">\n<div class=\"c-message__message_blocks c-message__message_blocks--rich_text\" data-qa=\"message-text\">\n<div class=\"p-block_kit_renderer\" data-qa=\"block-kit-renderer\">\n<div class=\"p-block_kit_renderer__block_wrapper p-block_kit_renderer__block_wrapper--first\">\n<div class=\"p-rich_text_block\" dir=\"auto\">\n<p><i data-stringify-type=\"italic\">Correction: A previous version of this post incorrectly referred to Voxzogo, Biomarin\u2019s dwarfism drug. It is an injectable, not a pill.<\/i><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\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\/06\/05\/biotech-news-gilead-prep-hiv-biomarin-lykos-mdma-astrazeneca-fda-zepbound\/?utm_campaign=rss\">https:\/\/www.statnews.com\/2024\/06\/05\/biotech-news-gilead-prep-hiv-biomarin-lykos-mdma-astrazeneca-fda-zepbound\/?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. Good morning. Jason Mast here filling in for Elaine. We\u2019ve got a dramatic vote on psychedelic therapy, record drug shortages, bad (maybe?) news for Biomarin, and a new kind of PrEP. advertisement The need-to-know [&hellip;]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":606544,"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\/606541"}],"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=606541"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/606541\/revisions"}],"predecessor-version":[{"id":606543,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/606541\/revisions\/606543"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/606544"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=606541"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=606541"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=606541"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}