{"id":31294,"date":"2025-03-18T16:24:02","date_gmt":"2025-03-18T10:54:02","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=31294"},"modified":"2025-03-18T17:41:12","modified_gmt":"2025-03-18T12:11:12","slug":"pharma-news-for-alexion-encell-sydnexis","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-alexion-encell-sydnexis","title":{"rendered":"FDA Expands SOLIRIS for Pediatric Myasthenia Gravis; vTv\u2019s Cadisegliatin Program Resumes as FDA Lifts Hold; ENCell\u2019s EN001 Wins Orphan Drug Designation for Charcot-Marie-Tooth; FDA Accepts Sydnexis\u2019 NDA for SYD-101 in Pediatric Myopia; Cambium Bio\u2019s Potency Assay Strategy Cleared for Elate Ocular Phase III Trials"},"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-6a39595554363\" 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-6a39595554363\"  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-alexion-encell-sydnexis\/#MDA_Applauds_FDAs_Expanded_Approval_of_Soliris_for_Pediatric_Generalized_Myasthenia_Gravis\" >MDA Applauds FDA\u2019s Expanded Approval of Soliris for Pediatric Generalized Myasthenia Gravis<\/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-alexion-encell-sydnexis\/#vTv_Therapeutics_Cadisegliatin_Program_Resumes_as_FDA_Lifts_Clinical_Hold\" >vTv Therapeutics&#8217; Cadisegliatin Program Resumes as FDA Lifts Clinical Hold<\/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-alexion-encell-sydnexis\/#ENCells_EN001_Granted_Orphan_Drug_Designation_for_Charcot-Marie-Tooth_Disease\" >ENCell\u2019s EN001 Granted Orphan Drug Designation for Charcot-Marie-Tooth Disease<\/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-alexion-encell-sydnexis\/#FDA_Accepts_Sydnexis_NDA_for_SYD-101_in_Pediatric_Myopia\" >FDA Accepts Sydnexis\u2019 NDA for SYD-101 in Pediatric Myopia<\/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-alexion-encell-sydnexis\/#Cambium_Bios_Potency_Assay_Strategy_Approved_for_Elate_Ocular_Phase_III_Trials\" >Cambium Bio\u2019s Potency Assay Strategy Approved for Elate Ocular Phase III Trials<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-mda-applauds-fda-s-expanded-approval-of-soliris-for-pediatric-generalized-myasthenia-gravis\"><span class=\"ez-toc-section\" id=\"MDA_Applauds_FDAs_Expanded_Approval_of_Soliris_for_Pediatric_Generalized_Myasthenia_Gravis\"><\/span>MDA Applauds FDA\u2019s Expanded Approval of Soliris for Pediatric Generalized Myasthenia Gravis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <strong>Muscular Dystrophy Association (MDA) <\/strong>celebrates the FDA approval of an expanded indication for <strong>Alexion\/AstraZeneca\u2019s eculizumab (Soliris)<\/strong>, now authorized for <strong>pediatric patients aged six and older <\/strong>with <a href=\"https:\/\/www.delveinsight.com\/report-store\/generalized-myasthenia-gravis-gmg-market\" class=\"ek-link\"><strong>generalized myasthenia gravis (gMG)<\/strong><\/a> who are anti-acetylcholine receptor (AChR) antibody positive. This milestone makes Soliris the first and only treatment available for pediatric gMG patients, addressing a significant unmet need in this population. The decision builds on clinical trial data from adult gMG patients, along with pharmacokinetic and safety data from pediatric studies. A 26-week study in adolescents aged 12 to 17 showed that adverse reactions were consistent with those observed in adults. <\/p>\n\n\n\n<p>Administered via intravenous infusion, Soliris remains under a restricted Risk Evaluation and Mitigation Strategy (REMS) program due to the risk of serious meningococcal infections. Patients must be vaccinated against meningococcal disease at least two weeks before starting treatment. First approved in 2007 for paroxysmal nocturnal hemoglobinuria, Soliris has since gained multiple indications, including for atypical hemolytic uremic syndrome, adult gMG, and neuromyelitis optica spectrum disorder.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis approval represents a major advancement in the treatment of pediatric myasthenia gravis and provides hope to families navigating this complex disease,\u201d <\/em><strong><em>said Sharon Hesterlee, PhD, Chief Research Officer at the Muscular Dystrophy Association (MDA).<\/em><\/strong><em> \u201cThe availability of Soliris for children underscores the importance of continued research and innovation in neuromuscular disease treatments.\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><strong><em>Donald S. Wood, PhD, President and CEO of MDA, <\/em><\/strong><em>highlighted the role of nonprofit organizations in advancing rare disease treatments. \u201cThe approval of Soliris for pediatric myasthenia gravis is a major milestone\u2014proof of how far science has come thanks to donors and supporters who believe in the power of scientific possibility,\u201d he said. \u201cBy funding research, advocating for the community, and working alongside industry partners, we are pushing the boundaries to bring life-changing therapies to people with neuromuscular diseases.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-vtv-therapeutics-cadisegliatin-program-resumes-as-fda-lifts-clinical-hold\"><span class=\"ez-toc-section\" id=\"vTv_Therapeutics_Cadisegliatin_Program_Resumes_as_FDA_Lifts_Clinical_Hold\"><\/span>vTv Therapeutics&#8217; Cadisegliatin Program Resumes as FDA Lifts Clinical Hold<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>vTv Therapeutics<\/strong> announced that the FDA has lifted the clinical hold on its<strong> cadisegliatin clinical program,<\/strong> including the <strong>CATT1 Phase III trial<\/strong> for <a href=\"https:\/\/www.delveinsight.com\/report-store\/type-1-diabetes-market\" class=\"ek-link\"><strong>type 1 diabetes (T1D)<\/strong><\/a>. Cadisegliatin, a liver-selective glucokinase activator, is being developed as a first-in-class oral adjunctive therapy to insulin and has been well tolerated in over 500 subjects with up to six months of treatment.<\/p>\n\n\n\n<p>To expedite topline data collection, vTv plans to submit a protocol amendment reducing the trial duration from 12 months to 6 months while maintaining the original primary endpoint of assessing level 2 and 3 hypoglycemia rates at 6 months. This adjustment will accelerate the initiation of pivotal studies required for a future New Drug Application (NDA) submission.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are pleased that the FDA has lifted the clinical hold on our cadisegliatin program and are eager to resume our Phase III trial,\u201d said Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics. \u201cBy shortening the trial duration, we can obtain data sooner and advance cadisegliatin toward becoming the first oral adjunctive therapy to insulin for T1D.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The FDA initially placed a hold on the CATT1 trial in July 2024 due to an unresolved chromatographic signal in an absorption, distribution, metabolism, and excretion (ADME) study. No patients had been dosed at the time, and past clinical trials showed no safety concerns. The hold was lifted on March 14, 2025, after vTv\u2019s response demonstrated the signal was an experimental artifact.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-encell-s-en001-granted-orphan-drug-designation-for-charcot-marie-tooth-disease\"><span class=\"ez-toc-section\" id=\"ENCells_EN001_Granted_Orphan_Drug_Designation_for_Charcot-Marie-Tooth_Disease\"><\/span>ENCell\u2019s EN001 Granted Orphan Drug Designation for Charcot-Marie-Tooth Disease<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>ENCell<\/strong> announced that its investigational stem cell therapy, <strong>EN001<\/strong>, has received an <strong>Orphan Drug Designation (ODD)<\/strong> from the FDA for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/charcot-marie-tooth-disease-market\" class=\"ek-link\">treatment of <strong>Charcot-Marie-Tooth disease (CMT)<\/strong><\/a>. CMT is a progressive neuromuscular disorder with no approved treatments, making this designation a significant step toward addressing an unmet medical need.<\/p>\n\n\n\n<p>EN001, developed using ENCell\u2019s proprietary ENCT platform, enhances cell longevity and optimizes the secretion of therapeutic molecules. The therapy targets damaged nerves, promotes regenerative factor secretion, and supports remyelination. A Phase I trial in CMT type 1A patients showed no dose-limiting toxicity, serious adverse events, or injection-related reactions. Based on these results, a high-dose Phase Ib trial was initiated in December 2024, with completion expected in 2025.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe FDA\u2019s Orphan Drug Designation for EN001 is a significant milestone that will accelerate its clinical development,\u201d <\/em><strong><em>an ENCell representative stated<\/em><\/strong><em>. \u201cWe are committed to completing the ongoing Phase Ib trial and ensuring timely access to this innovative treatment for CMT patients.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Beyond CMT, EN001 is being explored for <a href=\"https:\/\/www.delveinsight.com\/report-store\/duchenne-muscular-dystrophy-market\">Duchenne Muscular Dystrophy (DMD<\/a>) and <a href=\"https:\/\/www.delveinsight.com\/report-store\/sarcopenia-market\">Sarcopenia<\/a>, positioning it as a promising next-generation stem cell therapy for muscular diseases.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-accepts-sydnexis-nda-for-syd-101-in-pediatric-myopia\"><span class=\"ez-toc-section\" id=\"FDA_Accepts_Sydnexis_NDA_for_SYD-101_in_Pediatric_Myopia\"><\/span>FDA Accepts Sydnexis\u2019 NDA for SYD-101 in Pediatric Myopia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Sydnexis<\/strong> announced that the FDA has accepted its <strong>New Drug Application (NDA)<\/strong> for SYD-101, a potential first-in-class <a href=\"https:\/\/www.delveinsight.com\/report-store\/myopia-progression-market\">treatment for the <strong>progression of pediatric myopia<\/strong><\/a>, with a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would be the <strong><em>first FDA-approved pharmaceutical option<\/em><\/strong> for managing myopia progression in children across the U.S.<\/p>\n\n\n\n<p>The NDA is supported by data from the STAR Study, the largest clinical trial conducted for pediatric myopia treatment, enrolling over 850 children aged 3 to 14. The study evaluated the safety and efficacy of Sydnexis\u2019 proprietary low-dose atropine formulation over three years.&nbsp;<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201cSYD-101\u2019s novel formulation was designed to deliver superior drug activity, maximum stability, and optimal comfort,\u201d <strong><em>said Patrick Johnson, Ph.D., President of Sydnexis.<\/em><\/strong><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe FDA\u2019s acceptance of our NDA is a major step toward offering an innovative treatment for millions of children with progressive myopia,\u201d <\/em><strong><em>said Perry Sternberg, CEO of Sydnexis<\/em><\/strong><em>. \u201cWe look forward to working with the FDA to bring a once-daily, safe, and effective eye drop to patients, families, and clinicians.\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>Experts emphasize the growing need for an FDA-approved therapy for pediatric myopia. \u201cHaving a safe and effective treatment for myopic children would be a critical advancement in tackling this global epidemic,\u201d <\/em><strong><em>said Dr. Gregory Ostrow, Director of Pediatric Ophthalmology at Scripps Clinic. Dr. Paul Karpecki, OD, FAAO, added,<\/em><\/strong><em> \u201cA first FDA-approved option for early intervention is urgently needed to reduce the long-term risks associated with myopia.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-cambium-bio-s-potency-assay-strategy-approved-for-elate-ocular-phase-iii-trials\"><span class=\"ez-toc-section\" id=\"Cambium_Bios_Potency_Assay_Strategy_Approved_for_Elate_Ocular_Phase_III_Trials\"><\/span>Cambium Bio\u2019s Potency Assay Strategy Approved for Elate Ocular Phase III Trials<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Cambium Bio<\/strong> has achieved a significant regulatory milestone, <strong>securing FDA approval<\/strong> for its <strong>potency assay strategy <\/strong>to support <strong>Phase III clinical trials<\/strong> of <strong>Elate Ocular<\/strong>, a novel biologic therapy for <a href=\"https:\/\/www.delveinsight.com\/report-store\/dry-eye-disease-market-insights\"><strong>moderate to severe dry eye disease<\/strong><\/a>. Following a successful Type D meeting, the FDA endorsed Cambium Bio\u2019s proposed cell-based assay, alongside EGF and PDGF-BB ELISA assays, as a suitable lot release potency assay through to a future Biologics License Application (BLA) submission.<\/p>\n\n\n\n<p>Additionally, the FDA approved the company\u2019s approach to establishing acceptance criteria for the cell-based EGF activity bioassay, which will be used to assess clinical trial material and the eventual commercial product. The agency also confirmed the bioassay&#8217;s suitability for incorporation into a comparability protocol, ensuring consistency between Phase I\/II investigational products and the pathogen-inactivated Phase III formulation.<\/p>\n\n\n\n<p>These positive outcomes mark one of the final Chemistry, Manufacturing, and Controls (CMC) hurdles before Cambium Bio moves forward with its pivotal Phase III trials, expected to begin in mid-2025. The company will now focus on finalizing the validation of this potency assay with its Contract Development and Manufacturing Organization (CDMO) to meet regulatory requirements ahead of trial initiation.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe FDA\u2019s agreement on our potency assay strategy represents a critical regulatory milestone as we prepare to advance Elate Ocular\u00ae into Phase III trials,\u201d<\/em><strong><em> said Karolis Rosickas, CEO of Cambium Bio<\/em><\/strong><em>. \u201cThis validation underscores the strength of our CMC and analytical development approach and keeps us on track to initiate our registration-enabling Phase III program mid-year.\u201d<\/em><\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>MDA Applauds FDA\u2019s Expanded Approval of Soliris for Pediatric Generalized Myasthenia Gravis The Muscular Dystrophy Association (MDA) celebrates the FDA approval of an expanded indication for Alexion\/AstraZeneca\u2019s eculizumab (Soliris), now authorized for pediatric patients aged six and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. This milestone makes Soliris the [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":31295,"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":[18819,18820,204,18957,1796,704,18983,19602,349,17068,420,639,5789,824,17722],"industry":[17225],"therapeutic_areas":[17240,17238,17227,17244],"class_list":["post-31294","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-charcot-marie-tooth-disease-market","tag-charcot-marie-tooth-disease-pipeline","tag-delveinsight","tag-dry-eye-disease","tag-duchenne-muscular-dystrophy","tag-fda","tag-generalized-myasthenia-gravis","tag-generalized-myasthenia-gravis-market","tag-latest-pharma-news","tag-myopia","tag-news","tag-pharma-news","tag-recent-pharma-news","tag-sarcopenia","tag-type-1-diabetes","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-genetic-disorders","therapeutic_areas-immunological-and-autoimmune-disorders","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 | Alexion, ENCell, Sydnexis<\/title>\n<meta name=\"description\" content=\"AstraZeneca\u2019s SOLIRIS, vTv Therapeutics\u2019 Cadisegliatin, ENCell\u2019s EN001 ODD Approval, Sydnexis\u2019 SYD-101, Cambium\u2019s Potency Assay Strategy\" \/>\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-alexion-encell-sydnexis\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Alexion, ENCell, Sydnexis\" \/>\n<meta property=\"og:description\" content=\"AstraZeneca\u2019s SOLIRIS, vTv Therapeutics\u2019 Cadisegliatin, ENCell\u2019s EN001 ODD Approval, Sydnexis\u2019 SYD-101, Cambium\u2019s Potency Assay Strategy\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-alexion-encell-sydnexis\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-03-18T10:54:02+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-18T12:11:12+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/03\/18162322\/pharma-news-for-alexion-encell-sydnexis.png\" \/>\n\t<meta property=\"og:image:width\" content=\"772\" \/>\n\t<meta property=\"og:image:height\" content=\"482\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Jatin Vimal\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jatin Vimal\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Pharma News | Alexion, ENCell, Sydnexis","description":"AstraZeneca\u2019s SOLIRIS, vTv Therapeutics\u2019 Cadisegliatin, ENCell\u2019s EN001 ODD Approval, Sydnexis\u2019 SYD-101, Cambium\u2019s Potency Assay Strategy","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-alexion-encell-sydnexis","og_locale":"en_US","og_type":"article","og_title":"Pharma News | Alexion, ENCell, Sydnexis","og_description":"AstraZeneca\u2019s SOLIRIS, vTv Therapeutics\u2019 Cadisegliatin, ENCell\u2019s EN001 ODD Approval, Sydnexis\u2019 SYD-101, Cambium\u2019s Potency Assay Strategy","og_url":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-alexion-encell-sydnexis","og_site_name":"DelveInsight Business Research","article_publisher":"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/","article_published_time":"2025-03-18T10:54:02+00:00","article_modified_time":"2025-03-18T12:11:12+00:00","og_image":[{"width":772,"height":482,"url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/03\/18162322\/pharma-news-for-alexion-encell-sydnexis.png","type":"image\/png"}],"author":"Jatin Vimal","twitter_card":"summary_large_image","twitter_creator":"@DelveInsight","twitter_site":"@DelveInsight","twitter_misc":{"Written by":"Jatin Vimal","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-alexion-encell-sydnexis","url":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-alexion-encell-sydnexis","name":"Pharma News | Alexion, ENCell, Sydnexis","isPartOf":{"@id":"https:\/\/www.delveinsight.com\/blog\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-alexion-encell-sydnexis#primaryimage"},"image":{"@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-alexion-encell-sydnexis#primaryimage"},"thumbnailUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/03\/18162322\/pharma-news-for-alexion-encell-sydnexis.png","datePublished":"2025-03-18T10:54:02+00:00","dateModified":"2025-03-18T12:11:12+00:00","author":{"@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/c846f0323e948c55336d657b654f3158"},"description":"AstraZeneca\u2019s SOLIRIS, vTv Therapeutics\u2019 Cadisegliatin, ENCell\u2019s EN001 ODD Approval, Sydnexis\u2019 SYD-101, Cambium\u2019s Potency Assay Strategy","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.delveinsight.com\/blog\/pharma-news-for-alexion-encell-sydnexis"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-alexion-encell-sydnexis#primaryimage","url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/03\/18162322\/pharma-news-for-alexion-encell-sydnexis.png","contentUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/03\/18162322\/pharma-news-for-alexion-encell-sydnexis.png","width":772,"height":482,"caption":"pharma-news-for-alexion-encell-sydnexis"},{"@type":"WebSite","@id":"https:\/\/www.delveinsight.com\/blog\/#website","url":"https:\/\/www.delveinsight.com\/blog\/","name":"DelveInsight Business Research","description":"Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.delveinsight.com\/blog\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/c846f0323e948c55336d657b654f3158","name":"Jatin Vimal","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/10dcf4b5071c366691525fa20af33b87e8a3897e6d0acc1a2b09a7b99b8d8ae1?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/10dcf4b5071c366691525fa20af33b87e8a3897e6d0acc1a2b09a7b99b8d8ae1?s=96&d=mm&r=g","caption":"Jatin Vimal"},"sameAs":["https:\/\/www.delveinsight.com"]}]}},"author_meta":{"display_name":"Jatin Vimal","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/jatin"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/03\/18162322\/pharma-news-for-alexion-encell-sydnexis-300x187.png","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Charcot-Marie-Tooth Disease Market<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Charcot-Marie-Tooth Disease Pipeline<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">DelveInsight<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Dry Eye disease<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Duchenne muscular dystrophy<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">FDA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Generalized Myasthenia Gravis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">generalized myasthenia gravis market<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Latest pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">myopia<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">recent pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Sarcopenia<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Type 1 Diabetes<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Charcot-Marie-Tooth Disease Market<\/span>","<span class=\"advgb-post-tax-term\">Charcot-Marie-Tooth Disease Pipeline<\/span>","<span class=\"advgb-post-tax-term\">DelveInsight<\/span>","<span class=\"advgb-post-tax-term\">Dry Eye disease<\/span>","<span class=\"advgb-post-tax-term\">Duchenne muscular dystrophy<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">Generalized Myasthenia Gravis<\/span>","<span class=\"advgb-post-tax-term\">generalized myasthenia gravis market<\/span>","<span class=\"advgb-post-tax-term\">Latest pharma news<\/span>","<span class=\"advgb-post-tax-term\">myopia<\/span>","<span class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>","<span class=\"advgb-post-tax-term\">recent pharma news<\/span>","<span class=\"advgb-post-tax-term\">Sarcopenia<\/span>","<span class=\"advgb-post-tax-term\">Type 1 Diabetes<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 1 year ago","modified":"Updated 1 year ago"},"absolute_dates":{"created":"Posted on Mar 18, 2025","modified":"Updated on Mar 18, 2025"},"absolute_dates_time":{"created":"Posted on Mar 18, 2025 4:24 pm","modified":"Updated on Mar 18, 2025 5:41 pm"},"featured_img_caption":"pharma-news-for-alexion-encell-sydnexis\n","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/31294","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/20"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=31294"}],"version-history":[{"count":2,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/31294\/revisions"}],"predecessor-version":[{"id":31298,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/31294\/revisions\/31298"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/31295"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=31294"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=31294"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=31294"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=31294"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=31294"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}