{"id":8555,"date":"2024-04-19T02:22:00","date_gmt":"2024-04-19T02:22:00","guid":{"rendered":"https:\/\/economicherald.net\/?p=8555"},"modified":"2024-04-19T02:22:00","modified_gmt":"2024-04-19T02:22:00","slug":"asx-health-stocks-paradigm-responds-to-us-fda-seeks-marketing-approval-from-tga","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=8555","title":{"rendered":"ASX Health Stocks: Paradigm responds to US FDA, seeks marketing approval from TGA"},"content":{"rendered":"<p>Paradigm Biopharma submits response to the FDA<br \/>\n INOVIQ says its blood test on cancer is highly accurate<\/p>\n<p>\u00a0<\/p>\n<h2>Paradigm sends response to the US FDA<\/h2>\n<p><strong><a href=\"https:\/\/stockhead.com.au\/company\/paradigm-biopharmaceuticals-par\/\">Paradigm Biopharmaceuticals (ASX:PAR)<\/a><\/strong> announced that it has submitted important documents to the US FDA for reviewing and agreeing upon the next steps for its<strong> Phase 3 clinical program<\/strong> targeting <strong>osteoarthritis<\/strong> treatment.<\/p>\n<p>The submission includes responses to discussions from a Type D meeting held on January 1, presenting findings from five nonclinical studies, as well as data from a successful Phase 2 clinical trial, as well as clinical data from 600 participants.<\/p>\n<p>These additional data have not previously been reviewed by the FDA.<\/p>\n<p>Paradigm also submitted a draft of the Phase 3 clinical trial protocol for FDA review and comment.<\/p>\n<p>Along with justifications on the \u00a0minimal effective dose, the draft also presented the clinical trial protocol for Phase 3, updating the trial\u2019s safety monitoring plans.<\/p>\n<p>The FDA\u2019s feedback is expected within three months.<\/p>\n<p>Pending that clearance, Paradigm aims to start enrolling subjects for the <strong>Phase 3 trial (PARA_OA_012)<\/strong> in the second half of 2024. Preparation for clinical trial sites in Australia and the US are scheduled to begin in this quarter.<\/p>\n<p>\u00a0<\/p>\n<h2>TGA marketing approval<\/h2>\n<p>Concurrently, Paradigm is also working on finalising its application for provisional approval from the <strong>Therapeutic Goods Administration (TGA)<\/strong> in Australia.<\/p>\n<p>This application will include data from a manuscript detailing the results of the PARA_OA_008 Phase 2 clinical trial on its lead drug iPPS, and another manuscript comparing clinical data with other treatments for osteoarthritis.<\/p>\n<p>If the TGA approves the application, Paradigm will then submit a full dossier for provisional approval marketing authorisation.<\/p>\n<p>A provisional marketing approval from the TGA benefits both patients and manufacturers. Patients can access potentially life-saving treatments sooner, while manufacturers can bring innovative therapies to market faster and gather more data for full approval.<\/p>\n<p>Getting provisional marketing approval from the TGA for iPPS in Australia would also speed up the process to generate revenues for Paradigm.<\/p>\n<p>The manuscripts are currently being prepared and will be submitted to different journals for peer review and publication.<\/p>\n<p>\u00a0<\/p>\n<h2>INOVIQ says its ovarian cancer blood test is highly accurate<\/h2>\n<p>Meanwhile, <strong><a href=\"https:\/\/stockhead.com.au\/company\/inoviq-iiq\/\">INOVIQ (ASX:IIQ)<\/a><\/strong> has announced the successful completion of a study validating its <strong>blood test for ovarian cancer.<\/strong><\/p>\n<p>The results showed that the test accurately identified 85% of all samples tested, including 76% of cancer samples and 94% of cancer-free samples.<\/p>\n<p>This blood test combines a CA125 monoclonal antibody with INOVIQ\u2019s<strong> SubB2M detection reagent.<\/strong><\/p>\n<p>A CA125 test measures the amount of the protein CA 125 (cancer antigen 125) in the blood.<\/p>\n<p>INOVIQ says the study results have excellent reproducibility, a low limit of quantitation, and high overall accuracy, matching a leading CA125 test for ovarian cancer detection.<\/p>\n<p>INOVIQ is essentially seeking to demonstrate if its SubB2M technology can be a superior detection reagent to improve the performance of multiple cancer biomarker tests.<\/p>\n<p>The study aims to showcase the commercial potential of SubB2M for multiple cancers.<\/p>\n<p>\u00a0<\/p>\n<h2>Share prices today:<\/h2>\n<p>\u00a0<\/p>\n\n<p><span class=\"mce_SELRES_start\">\ufeff<\/span><span class=\"mce_SELRES_start\"><\/span>\u00a0<br \/>\n<span class=\"et_bloom_bottom_trigger\"><\/span><\/p>\n<p>The post <a href=\"https:\/\/stockhead.com.au\/health\/asx-health-stocks-paradigm-responds-to-us-fda-seeks-marketing-approval-from-tga\/\">ASX Health Stocks: Paradigm responds to US FDA, seeks marketing approval from TGA<\/a> appeared first on <a href=\"https:\/\/stockhead.com.au\/\">Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Paradigm Biopharma submits response to the FDA INOVIQ says its blood test on cancer is highly accurate \u00a0 Paradigm sends response to the US FDA <a href=\"https:\/\/economicherald.net\/?p=8555\" class=\"read-more-link\">[more&#8230;]<\/a><\/p>\n","protected":false},"author":0,"featured_media":8556,"comment_status":"","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-8555","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-finance"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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