{"id":1319,"date":"2016-10-04T17:55:03","date_gmt":"2016-10-04T12:25:03","guid":{"rendered":"https:\/\/delveinsightblog.wordpress.com\/?p=1319"},"modified":"2021-07-24T12:56:33","modified_gmt":"2021-07-24T07:26:33","slug":"notizia-9","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-9","title":{"rendered":"FDA Approves STELARA; Novartis announces AMG 334; AbbVie&#8217;s HCV Regimen; PaizaBio Gains CFDA Approval; WuXi Biologics completes construction"},"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-69fc5dad92172\" 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-69fc5dad92172\"  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-9\/#FDA_Approves_Janssens_STELARA_for_the_Treatment_of_Adults_With_Moderately_to_Severely_Active_Crohns_Disease\" >FDA Approves Janssen&#8217;s STELARA for the Treatment of Adults With Moderately to Severely Active Crohn\u2019s Disease<\/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-9\/#Novartis_announces_AMG_334_significantly_reduces_monthly_migraine_days_in_people_with_episodic_migraine\" >Novartis announces AMG 334 significantly reduces monthly migraine days in people with episodic migraine<\/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-9\/#AbbVies_Investigational_HCV_Regimen_Receives_US_FDA_Breakthrough_Therapy_Designation\" >AbbVie&#8217;s Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation<\/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-9\/#PaizaBio_Gains_CFDA_Approval_to_Expand_FillFinish_Capacity\" >PaizaBio Gains CFDA Approval to Expand Fill\/Finish Capacity<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-9\/#WuXi_Biologics_completes_construction_of_Asias_largest_perfusion_biologics_manufacturing_facility_using_disposable_bioreactors\" >WuXi Biologics completes construction of Asia\u2019s largest perfusion biologics manufacturing facility using disposable bioreactors<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Janssens_STELARA_for_the_Treatment_of_Adults_With_Moderately_to_Severely_Active_Crohns_Disease\"><\/span>FDA Approves Janssen&#8217;s STELARA for the Treatment of Adults With Moderately to Severely Active Crohn\u2019s Disease<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Janssen Biotech Inc. received approval from the U.S. FDA for STELARA (ustekinumab), used for the treatment of moderately to severely active Crohn\u2019s disease in adults (18 years or older). The drug is for the patients who have failed or were intolerant to treatment with immune-modulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers. Janssen will work closely with payers, providers and pharmacy benefit managers to ensure STELARA\u00ae is broadly accessible and affordable for patients.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Novartis_announces_AMG_334_significantly_reduces_monthly_migraine_days_in_people_with_episodic_migraine\"><\/span>Novartis announces AMG 334 significantly reduces monthly migraine days in people with episodic migraine<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Novartis announced positive topline results from ARISE, the first Phase III study evaluating the efficacy and safety of monthly subcutaneous AMG 334 (erenumab) 70mg in episodic migraine prevention. The Phase III study met its primary endpoint, showing a statistically significant reduction in monthly migraine days vs placebo.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"AbbVies_Investigational_HCV_Regimen_Receives_US_FDA_Breakthrough_Therapy_Designation\"><\/span>AbbVie&#8217;s Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">AbbVie, a global biopharmaceutical company, got \u00a0Breakthrough Therapy Designation (BTD) from the U.S. FDA for pan-genotypic regimen of glecaprevir (ABT-493)\/pibrentasvir (ABT-530) (G\/P), which is used for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and\/or protease inhibitor. The BTD is supported by positive results seen in AbbVie&#8217;s Phase 2 MAGELLAN-1 clinical study.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"PaizaBio_Gains_CFDA_Approval_to_Expand_FillFinish_Capacity\"><\/span>PaizaBio Gains CFDA Approval to Expand Fill\/Finish Capacity<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">PaizaBio gained approval from China\u2019s FDA (CFDA) to add new aseptic injectable production capability at it production facility in Hangzhou, China. This expansion will increase the company\u2019s annual fill\/finish capacity from 300 million units to 400 million, including vials, pre-filled syringes and cartridges. \u00a0The capacity will focus on small molecule drugs for clinical trials and small batch production and the company anticipates reaching full-scale production by 1Q17.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"WuXi_Biologics_completes_construction_of_Asias_largest_perfusion_biologics_manufacturing_facility_using_disposable_bioreactors\"><\/span>WuXi Biologics completes construction of Asia\u2019s largest perfusion biologics manufacturing facility using disposable bioreactors<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">WuXi Biologics, an open-access R&amp;D capability and technology platform company, has announced the opening of a new commercial-scale cGMP biologics perfusion manufacturing facility in Wuxi city, China. The new facility accommodates two 1000L disposable bioreactors for perfusion processes and is the largest perfusion biologics manufacturing facility to date in Asia implementing disposable bioreactors.<\/p>\n<h2 style=\"text-align: justify;\"><\/h2>\n<h2 style=\"text-align: justify;\"><\/h2>\n","protected":false},"excerpt":{"rendered":"<p>FDA Approves Janssen&#8217;s STELARA for the Treatment of Adults With Moderately to Severely Active Crohn\u2019s Disease Janssen Biotech Inc. received approval from the U.S. FDA for STELARA (ustekinumab), used for the treatment of moderately to severely active Crohn\u2019s disease in adults (18 years or older). The drug is for the patients who have failed or [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1173,"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":[56,17367,17368,2077,704,1657,423,17365,17362,17366],"industry":[17225],"therapeutic_areas":[17239,17231,17245],"class_list":["post-1319","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-abbvie","tag-amg-334","tag-cfda","tag-crohns-disease","tag-fda","tag-janssen","tag-novartis","tag-paizabio","tag-stelara","tag-wuxi-biologics","industry-pharmaceutical","therapeutic_areas-gastroenterology","therapeutic_areas-infectious-diseases","therapeutic_areas-neurology"],"acf":[],"yoast_head":"<!-- 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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\">AbbVie<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">AMG 334<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">CFDA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Crohn\u2019s disease<\/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\">Janssen<\/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\">PaizaBio<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Stelara<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">WuXi Biologics<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">AbbVie<\/span>","<span class=\"advgb-post-tax-term\">AMG 334<\/span>","<span class=\"advgb-post-tax-term\">CFDA<\/span>","<span class=\"advgb-post-tax-term\">Crohn\u2019s disease<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">Janssen<\/span>","<span class=\"advgb-post-tax-term\">Novartis<\/span>","<span class=\"advgb-post-tax-term\">PaizaBio<\/span>","<span class=\"advgb-post-tax-term\">Stelara<\/span>","<span class=\"advgb-post-tax-term\">WuXi Biologics<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 10 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Oct 4, 2016","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Oct 4, 2016 5:55 pm","modified":"Updated on Jul 24, 2021 12:56 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