{"id":30930,"date":"2025-02-04T14:30:08","date_gmt":"2025-02-04T09:00:08","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=30930"},"modified":"2025-02-04T14:30:10","modified_gmt":"2025-02-04T09:00:10","slug":"pharma-news-for-astrazeneca-vertex-axsome","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-vertex-axsome","title":{"rendered":"AstraZeneca Scraps \u00a3450M UK Vaccine Factory; FDA Approves First Non-Opioid Pain Reliever JOURNAVX in 20+ Years; Axsome\u2019s SYMBRAVO Wins FDA Nod for Migraine; March Biosciences&#8217; MB-105 Gains FDA Orphan Status for T-Cell Lymphoma; Saol&#8217;s SL1009 NDA Accepted for Pyruvate Dehydrogenase Complex Deficiency"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a08a2a545158\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a08a2a545158\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-vertex-axsome\/#AstraZeneca_Scraps_450M_Vaccine_Factory_in_UK_Dealing_a_Blow_to_Reeves\" >AstraZeneca Scraps \u00a3450M Vaccine Factory in UK, Dealing a Blow to Reeves<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-vertex-axsome\/#FDA_Approves_First_Non-Opioid_Pain_Reliever_JOURNAVX_in_over_20_Years\" >FDA Approves First Non-Opioid Pain Reliever JOURNAVX in over 20 Years<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-vertex-axsome\/#Axsomes_SYMBRAVO_Wins_FDA_Nod_for_Migraine_Treatment\" >Axsome\u2019s SYMBRAVO Wins FDA Nod for Migraine Treatment<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-vertex-axsome\/#March_Biosciences_MB-105_Gains_FDA_Orphan_Drug_Status_for_T-Cell_Lymphoma\" >March Biosciences&#8217; MB-105 Gains FDA Orphan Drug Status for T-Cell Lymphoma<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-vertex-axsome\/#FDA_Accepts_Saol_Therapeutics_NDA_for_SL1009_in_Pyruvate_Dehydrogenase_Complex_Deficiency\" >FDA Accepts Saol Therapeutics&#8217; NDA for SL1009 in Pyruvate Dehydrogenase Complex Deficiency<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-astrazeneca-scraps-450m-vaccine-factory-in-uk-dealing-a-blow-to-reeves\"><span class=\"ez-toc-section\" id=\"AstraZeneca_Scraps_450M_Vaccine_Factory_in_UK_Dealing_a_Blow_to_Reeves\"><\/span>AstraZeneca Scraps \u00a3450M Vaccine Factory in UK, Dealing a Blow to Reeves<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>AstraZeneca has withdrawn its planned \u00a3450 million<\/strong> investment to expand a vaccine manufacturing facility in Liverpool, citing <strong>reduced financial support from the new Labour government.<\/strong> Initially announced in the previous Conservative government\u2019s budget, the expansion was intended to enhance the <strong>UK\u2019s life sciences sector.<\/strong> However, the pharmaceutical company decided to halt the project after negotiations with the Treasury resulted in a lower funding offer than initially proposed.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Despite the cancellation, AstraZeneca confirmed that its existing Speke facility would continue to operate, ensuring flu vaccine production for both UK and global markets. <\/em><strong><em>\u201cSeveral factors influenced this decision, including the timing and reduction of the final offer compared to the previous government\u2019s proposal,\u201d<\/em><\/strong><em> a company spokesperson stated.<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>A government representative defended the move, explaining that adjustments to AstraZeneca\u2019s investment plan led to a lower grant offer. \u201cAll government grant funding must demonstrate value for the taxpayer, and despite extensive work, a solution was not possible,\u201d the spokesperson said.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The decision comes as a blow to Chancellor Rachel Reeves, who recently emphasized the life sciences industry as a pillar of economic growth. In a speech earlier this week, she highlighted AstraZeneca\u2019s role in the sector and announced plans to develop an Oxford-Cambridge growth corridor, which she projected could contribute \u00a378 billion to the economy.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-first-non-opioid-pain-reliever-journavx-in-over-20-years\"><span class=\"ez-toc-section\" id=\"FDA_Approves_First_Non-Opioid_Pain_Reliever_JOURNAVX_in_over_20_Years\"><\/span>FDA Approves First Non-Opioid Pain Reliever JOURNAVX in over 20 Years<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <strong>FDA has approved JOURNAVX\u2122 (suzetrigine),<\/strong> an oral, <strong>non-opioid pain signal inhibitor <\/strong>developed by Vertex Pharmaceuticals for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/acute-pain-market\"><strong>adults with moderate-to-severe acute pain<\/strong><\/a>. JOURNAVX selectively targets the NaV1.8 pain pathway, providing an effective alternative to opioids while demonstrating a favorable safety profile with no evidence of addictive potential. This approval marks a significant advancement in pain management, as it is the first new class of pain medication approved in over two decades.<\/p>\n\n\n\n<p>With an <strong>estimated 80 million Americans<\/strong> prescribed medications for moderate-to-severe acute pain annually, the approval of JOURNAVX introduces a much-needed alternative in a landscape dominated by opioids. The drug\u2019s ability to provide effective pain relief without the risks associated with opioid dependence could shift the standard of care for pain management. Vertex has also implemented patient support programs to ensure accessibility for those in need.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis is an incredible day for patients and physicians alike who now have an approved non-opioid treatment that delivers effective acute pain relief and a favorable safety profile without addictive potential,\u201d said Jessica Oswald, M.D., a pain medicine specialist. \u201cJOURNAVX could redefine the management of pain and become a foundational treatment option where alternatives to opioids have been desperately needed.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-axsome-s-symbravo-wins-fda-nod-for-migraine-treatment\"><span class=\"ez-toc-section\" id=\"Axsomes_SYMBRAVO_Wins_FDA_Nod_for_Migraine_Treatment\"><\/span>Axsome\u2019s SYMBRAVO Wins FDA Nod for Migraine Treatment<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Axsome Therapeutics<\/strong> announced that the <strong>FDA has approved SYMBRAVO (meloxicam and rizatriptan)<\/strong> for the <strong>acute <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/migraine-market\"><strong>treatment of migraine with or without aura in adults<\/strong><\/a><strong>.<\/strong> SYMBRAVO introduces a novel, multi-mechanistic approach, targeting multiple pathways to rapidly alleviate migraine pain and provide sustained relief for up to 48 hours in some patients. The drug is expected to be commercially available in the U.S. within the next four months.<\/p>\n\n\n\n<p>Clinical trials, including <strong>MOMENTUM <\/strong>and <strong>INTERCEPT<\/strong>, demonstrated SYMBRAVO\u2019s effectiveness in treating mild to severe migraine pain while reducing the need for rescue medication. In a head-to-head comparison, it showed superiority over rizatriptan in providing sustained pain relief. The drug utilizes Axsome\u2019s MoSEICTM rapid absorption technology, allowing for faster onset while maintaining a long half-life.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cA significant proportion of migraine patients experience inadequate efficacy with current treatments, leading to increased suffering and attack frequency,\u201d said Dr. Richard B. Lipton, Professor of Neurology at Albert Einstein College of Medicine. \u201cThe approval of SYMBRAVO provides a much-needed new option for patients and clinicians, offering rapid and long-lasting relief.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>With migraine affecting over 39 million people in the U.S., SYMBRAVO represents a major advancement in acute migraine care. Axsome CEO Herriot Tabuteau, M.D., emphasized the company\u2019s commitment to addressing CNS disorders, stating, \u201cSYMBRAVO provides patients and clinicians with an important new option that can quickly stop a migraine attack and keep it away with just a single dose.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-march-biosciences-mb-105-gains-fda-orphan-drug-status-for-t-cell-lymphoma\"><span class=\"ez-toc-section\" id=\"March_Biosciences_MB-105_Gains_FDA_Orphan_Drug_Status_for_T-Cell_Lymphoma\"><\/span>March Biosciences&#8217; MB-105 Gains FDA Orphan Drug Status for T-Cell Lymphoma<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>March Biosciences <\/strong>announced that the <strong>FDA<\/strong> has <strong>granted orphan drug designation<\/strong> to its first-in-class <a href=\"https:\/\/www.delveinsight.com\/report-store\/chimeric-antigen-receptor-car-t-cell-therapy-market\"><strong>CD5-targeted CAR-T cell therapy<\/strong><\/a><strong>, MB-105,<\/strong> for treating <a href=\"https:\/\/www.delveinsight.com\/report-store\/relapsed-and-refractory-cd5-expressing-t-cell-lymphomas-pipeline-insight\">relapsed or <strong>refractory CD5-positive T-cell lymphoma<\/strong><\/a><strong>.<\/strong><\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis designation is not only an important regulatory milestone but also underscores the urgent need for new treatment options for patients with T-cell lymphoma,\u201d said Sarah Hein, Co-Founder and CEO of March Biosciences. \u201cCurrent treatment options for patients with treatment-resistant T-cell cancers are limited, and the promising safety and efficacy signals observed in our Phase I trial validate our development strategy as we prepare to launch our Phase II clinical trial in early 2025.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Orphan drug designation, granted to therapies targeting rare diseases affecting fewer than 200,000 people in the U.S., offers various incentives such as tax credits for clinical testing, fee exemptions, and seven years of market exclusivity upon FDA approval.<\/p>\n\n\n\n<p>MB-105 is the lead program from March Bio\u2019s collaboration with the Center for Cell and Gene Therapy and other renowned institutions. The company has secured $28.4 million in Series A funding to advance its Phase II trial and enhance its manufacturing capabilities for future commercialization.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-accepts-saol-therapeutics-nda-for-sl1009-in-pyruvate-dehydrogenase-complex-deficiency\"><span class=\"ez-toc-section\" id=\"FDA_Accepts_Saol_Therapeutics_NDA_for_SL1009_in_Pyruvate_Dehydrogenase_Complex_Deficiency\"><\/span>FDA Accepts Saol Therapeutics&#8217; NDA for SL1009 in Pyruvate Dehydrogenase Complex Deficiency<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Saol Therapeutics,<\/strong> a clinical-stage pharmaceutical company, announced that the FDA has accepted the <strong>New Drug Application (NDA) <\/strong>for <strong>SL1009 (Sodium Dichloroacetate Oral Solution, DCA),<\/strong> intended for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/pyruvate-kinase-deficiency-market\">treatment of <strong>Pyruvate Dehydrogenase Complex Deficiency (PDCD)<\/strong><\/a>, a rare and life-threatening mitochondrial disorder affecting children. The FDA has granted Priority Review for the NDA, with a goal date of May 27, 2025, under the Prescription Drug User Fee Act (PDUFA). This designation highlights the potential for SL1009 to improve treatment options for this serious condition significantly.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are one step closer to addressing the critical challenges faced by children with PDCD, where no approved treatment currently exists,\u201d said Dave Penake, CEO of Saol Therapeutics. \u201cThis NDA acceptance is a significant scientific achievement and a meaningful moment for everyone involved in advancing this therapy.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>SL1009, which targets Pyruvate Dehydrogenase Kinase (PDK) to stimulate Pyruvate Dehydrogenase Complex (PDC) activity and increase ATP production, has already received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the FDA, with eligibility for a Priority Review Voucher (PRV).<\/p>\n\n\n\n<p>The NDA submission is supported by data from Phase III studies, including a double-blind placebo-controlled cross-over study and a survival study, demonstrating the safety and clinical benefits of DCA in PDCD patients.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>AstraZeneca Scraps \u00a3450M Vaccine Factory in UK, Dealing a Blow to Reeves AstraZeneca has withdrawn its planned \u00a3450 million investment to expand a vaccine manufacturing facility in Liverpool, citing reduced financial support from the new Labour government. Initially announced in the previous Conservative government\u2019s budget, the expansion was intended to enhance the UK\u2019s life sciences [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":30931,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[21364,19776,204,704,349,1193,18082,1495,420,639,2669,5789],"industry":[17225],"therapeutic_areas":[17245,17228,17244],"class_list":["post-30930","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-acute-pain","tag-adult-t-cell-lymphoma","tag-delveinsight","tag-fda","tag-latest-pharma-news","tag-migraine","tag-migraine-treatment-market","tag-migraines","tag-news","tag-pharma-news","tag-pyruvate-dehydrogenase-isoenzyme-4","tag-recent-pharma-news","industry-pharmaceutical","therapeutic_areas-neurology","therapeutic_areas-oncology","therapeutic_areas-ophthalmology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pharma News | AstraZeneca, Vertex, Axsome<\/title>\n<meta name=\"description\" content=\"AstraZeneca\u2019s Vaccine Factory, Vertex\u2019s JOURNAVX, Axsome\u2019s SYMBRAVO, March Biosciences\u2019 MB-105, Saol\u2019s SL1009\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-vertex-axsome\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | AstraZeneca, Vertex, Axsome\" \/>\n<meta property=\"og:description\" content=\"AstraZeneca\u2019s Vaccine Factory, Vertex\u2019s JOURNAVX, Axsome\u2019s SYMBRAVO, March Biosciences\u2019 MB-105, Saol\u2019s SL1009\" \/>\n<meta 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