{"id":1293,"date":"2016-09-27T17:40:32","date_gmt":"2016-09-27T12:10:32","guid":{"rendered":"https:\/\/delveinsightblog.wordpress.com\/?p=1293"},"modified":"2021-07-24T12:56:32","modified_gmt":"2021-07-24T07:26:32","slug":"notizia-8","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-8","title":{"rendered":"FDA grants approval; Sanaria receives fast-track designation; Sanofi and Regeneron\u2019s next blockbuster; Allele receives NIH grant"},"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-6a06d02af2695\" 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-6a06d02af2695\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-8\/#US_FDA_grants_approval_for_Novartis_Ilaris_to_treat_Periodic_Fever_Syndromes\" >US FDA grants approval for Novartis&#8217; Ilaris to treat Periodic Fever Syndromes<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-8\/#Sanaria_receives_FDA_fast-track_designation_for_malaria_vaccine\" >Sanaria receives FDA fast-track designation for malaria vaccine<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-8\/#Sanofi_and_Regenerons_next_wannabe_blockbuster_tagged_%E2%80%98priority_by_Regulators\" >Sanofi and Regeneron\u2019s next wannabe blockbuster tagged \u2018priority\u2019 by Regulators<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-8\/#Allele_receives_NIH_grant_to_develop_new_antibody_therapy_for_Alzheimers_disease\" >Allele receives NIH grant to develop new antibody therapy for Alzheimer\u2019s disease<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"US_FDA_grants_approval_for_Novartis_Ilaris_to_treat_Periodic_Fever_Syndromes\"><\/span>US FDA grants approval for Novartis&#8217; Ilaris to treat Periodic Fever Syndromes<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Novartis received approval to market its Periodic Fever Syndrome drug Ilaris (cancakinumab). The drug targets the syndrome, and will be used to treat a group of diseases that cause serious recurrent fever and pathogenic inflammation through non-infectious activation of the immune system. Ilaris inhibits Interleukin-1 (IL-1) beta, and is already approved in the US to treat Cryopyrin-Associated Periodic Syndromes (CAPS) and Systemic Juvenile Idiopathic Arthritis (SJIA).<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Sanaria_receives_FDA_fast-track_designation_for_malaria_vaccine\"><\/span>Sanaria receives FDA fast-track designation for malaria vaccine<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">PfSPZ, the malaria vaccine of Sanaria, has received fast-track designation from the US Food and Drug Administration (FDA).PfSPZ is currently in clinical trials that are intended to finalise an immunisation regimen to be taken forward into pivotal Phase III clinical trials. If successful, the clinical trials provide the necessary data for licensing the vaccine, according to the company.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Sanofi_and_Regenerons_next_wannabe_blockbuster_tagged_%E2%80%98priority_by_Regulators\"><\/span>Sanofi and Regeneron\u2019s next wannabe blockbuster tagged \u2018priority\u2019 by Regulators<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">FDA has accepted the application for atopic dermatitis candidate dupilumab, from Sanofi and Regeneron, and have given it a priority review tag that should hasten its trip to approval. Dupilumab has already shown it can beat out those topical steroids, too. In June, its makers rolled out Phase III data showing that a dupilumab\/corticosteroid combo topped steroids alone. analysts see dupilumab generating more than $2.5 billion a year&#8211;with some predicting up to $4 billion or $5 billion.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Allele_receives_NIH_grant_to_develop_new_antibody_therapy_for_Alzheimers_disease\"><\/span>Allele receives NIH grant to develop new antibody therapy for Alzheimer\u2019s disease<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Allele Biotechnology and Pharmaceuticals (Allele) has secured a grant from the US National Institutes of Health&#8217;s (NIH) National Institute on Aging to develop a new antibody therapy for Alzheimer\u2019s disease. Allele will develop a panel of antibodies that identify this protein, one of which would be used as a therapeutic drug candidate. The antibodies will feature a distinct shape and size, allowing them to pass the blood-brain barrier to reach the critical areas of the brain. Allele researchers also aim to modify and engineer each antibody to enhance its therapeutic potential.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>US FDA grants approval for Novartis&#8217; Ilaris to treat Periodic Fever Syndromes Novartis received approval to market its Periodic Fever Syndrome drug Ilaris (cancakinumab). The drug targets the syndrome, and will be used to treat a group of diseases that cause serious recurrent fever and pathogenic inflammation through non-infectious activation of the immune system. Ilaris [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1298,"comment_status":"open","ping_status":"open","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":[17341,72,17343,704,1346,423,17342,504,17340,533],"industry":[17225],"therapeutic_areas":[17237,17227,17231,17245,17234],"class_list":["post-1293","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-allele","tag-alzheimers-disease","tag-antibody-therapy","tag-fda","tag-nih","tag-novartis","tag-periodic-fever-syndromes","tag-regeneron","tag-sanaria","tag-sanofi","industry-pharmaceutical","therapeutic_areas-dermatology","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-infectious-diseases","therapeutic_areas-neurology","therapeutic_areas-rare-diseases"],"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>FDA grants approval; Sanaria receives fast-track designation<\/title>\n<meta name=\"description\" content=\"Novartis received approval to market its Periodic Fever Syndrome drug Ilaris (cancakinumab). 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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\">Allele<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Alzheimer\u2019s disease<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Antibody Therapy<\/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\">NIH<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Novartis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Periodic Fever Syndromes<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Regeneron<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Sanaria<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Sanofi<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Allele<\/span>","<span class=\"advgb-post-tax-term\">Alzheimer\u2019s disease<\/span>","<span class=\"advgb-post-tax-term\">Antibody Therapy<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">NIH<\/span>","<span class=\"advgb-post-tax-term\">Novartis<\/span>","<span class=\"advgb-post-tax-term\">Periodic Fever Syndromes<\/span>","<span class=\"advgb-post-tax-term\">Regeneron<\/span>","<span class=\"advgb-post-tax-term\">Sanaria<\/span>","<span class=\"advgb-post-tax-term\">Sanofi<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 10 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Sep 27, 2016","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Sep 27, 2016 5:40 pm","modified":"Updated on Jul 24, 2021 12:56 pm"},"featured_img_caption":"","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/1293","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\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=1293"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/1293\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/1298"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=1293"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=1293"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=1293"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=1293"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=1293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}