{"id":2369,"date":"2017-10-10T17:51:37","date_gmt":"2017-10-10T12:21:37","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2369"},"modified":"2021-07-24T12:56:51","modified_gmt":"2021-07-24T07:26:51","slug":"notizia-54","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-54","title":{"rendered":"Novo petitions FDA;J&#038;J invests; Xarelto\u2019s trial; Roche&#8217;s Tecentriq"},"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-69fe059378f67\" 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-69fe059378f67\"  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-54\/#Novo_petitions_FDA_to_require_copies_of_Victoza_to_conduct_clinical_trials\" >Novo petitions FDA to require copies of Victoza to conduct clinical trials<\/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-54\/#J_J_invests_350M_in_EU_biologics_operation\" >J&amp;J invests $350M in EU biologics operation<\/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-54\/#Trial_failure_for_Xarelto_in_clot_prevention_Bayer_says_its_wont_affect_sales\" >Trial failure for Xarelto in clot prevention, Bayer says its won\u2019t affect sales<\/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-54\/#Roches_Tecentriq_cedes_bladder-cancer_share_to_Keytruda_in_wake_of_trial_misfire\" >Roche&#8217;s Tecentriq cedes bladder-cancer share to Keytruda in wake of trial misfire<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Novo_petitions_FDA_to_require_copies_of_Victoza_to_conduct_clinical_trials\"><\/span>Novo petitions FDA to require copies of Victoza to conduct clinical trials<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">With one drugmaker already trying to pry patent protection off of Novo Nordisk\u2019s blockbuster Victoza before its 2022 expiration, the insulin specialist has taken new steps to deter copies. The Danish drugmaker has filed a citizen petition arguing the manufacturing process for its drug is so complex that equivalence of a copy couldn\u2019t be certain without clinical trials. Actually, the petition, which Novo filed last week, asks the FDA to refrain from approving ANDAs that reference any of its liraglutide-containing drugs, which include Saxenda and Xultophy in addition to Victoza, the dominant GLP-1 in the market with $2.1 billion in U.S. sales last year. While FDA guidance already holds biosimilar manufacturers to a higher manufacturing standard than originators, Novo argues that the \u201c<em>complexity of the recombinant-derived liraglutide product and its efficacy and safety is specifically tied to the manufacturing process.<\/em>\u201d<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"J_J_invests_350M_in_EU_biologics_operation\"><\/span>J&amp;J invests $350M in EU biologics operation<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Johnson &amp; Johnson is making a big investment in its biologics capacity, this month starting a $350 million project to expand a site in Ireland, a move that will add 200 jobs. J&amp;J today confirmed the expansion in which its Janssen drug unit will invest more than \u20ac300 million to expand its Ringaskiddy, County Cork facility by 19,100 square meters (205,590 square feet). The project is kicking off this month and is expected to take two years to complete. Janssen says it will add 200 jobs to the site when the new facilities are up and running. In addition to the new manufacturing facility, the project includes expansion of an existing warehouse, laboratory and administration buildings, and expansion of the wastewater treatment plant to accommodate increased volumes.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Trial_failure_for_Xarelto_in_clot_prevention_Bayer_says_its_wont_affect_sales\"><\/span>Trial failure for Xarelto in clot prevention, Bayer says its won\u2019t affect sales<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">German pharma giant Bayer announced that it has stopped a trial of Xarelto in the secondary prevention of stroke and embolism for lack of efficacy, but Bayer who markets in partnership with Johnson &amp; Johnson says that the demise of the trial would not affect its sales estimates for Xarelto. The product has formidable rivals in Eliquis from Pfizer and Bristol-Myers Squibb and Boehringer Ingelheim\u2019s Pradaxa, with BI boasting the advantage of having an approved product that can be used alongside it in cases of uncontrolled bleeding. However, one of the reasons Bayer may be so confident about hitting that $5.3 billion peak sales goal for Xarelto is that it did chart one piece of good research news recently. At the European Society of Cardiology meeting in August, Bayer and J&amp;J released data showing that Xarelto paired with aspirin slashed the risk of adverse cardiovascular events in patients with coronary artery disease and\/or peripheral artery disease by 24% over aspirin by itself.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Roches_Tecentriq_cedes_bladder-cancer_share_to_Keytruda_in_wake_of_trial_misfire\"><\/span>Roche&#8217;s Tecentriq cedes bladder-cancer share to Keytruda in wake of trial misfire<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Roche may be able to keep its bladder cancer nod for Tecentriq despite its phase 3 failure to improve overall survival but might not keep its market share. Use of the med in the bladder-cancer space has been declining, with rival Keytruda from Merck \u201cdisplacing Tecentriq,\u201d, according to a Barclays analyst. Roche\u2019s drug, which was the first immuno-oncology agent of five to win a green light in the field, accounts for the greatest overall share of the bladder-cancer market&#8211;and half the immuno-oncology market for the indication. But use has been declining, as it first ran into trouble in May, when it announced that Tecentriq&#8211;approved last year on the basis of phase 2 data durable response data&#8211;couldn\u2019t significantly top chemo in a phase 3 study. The flop put Tecentriq\u2019s approval in question and raised red flags for fellow PD-1\/PD-L1 drugmakers who, aside from Merck, can\u2019t yet boast positive OS data of their own.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Novo petitions FDA to require copies of Victoza to conduct clinical trials With one drugmaker already trying to pry patent protection off of Novo Nordisk\u2019s blockbuster Victoza before its 2022 expiration, the insulin specialist has taken new steps to deter copies. The Danish drugmaker has filed a citizen petition arguing the manufacturing process for its [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1525,"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":[2063,134,173,180,204,345,356,386,877,427,696,524,2792,558,595,3663,1985],"industry":[17225],"therapeutic_areas":[17242,17240,17228],"class_list":["post-2369","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-bladder-cancer","tag-business-consultant","tag-collaborations","tag-competitive-landscape","tag-delveinsight","tag-keytruda","tag-licensing-opportunities","tag-market-trends","tag-novo-nordisk","tag-oncology","tag-research-and-development","tag-roche","tag-tecentriq","tag-technology-assessments","tag-usfda","tag-victoza","tag-xarelto","industry-pharmaceutical","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-oncology"],"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\">bladder cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Business Consultant<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">collaborations<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Competitive landscape<\/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\">Keytruda<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">licensing opportunities<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">market trends<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Novo Nordisk<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Oncology<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Research and Development<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Roche<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Tecentriq<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">technology assessments<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">USFDA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Victoza<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Xarelto<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">bladder cancer<\/span>","<span class=\"advgb-post-tax-term\">Business Consultant<\/span>","<span class=\"advgb-post-tax-term\">collaborations<\/span>","<span class=\"advgb-post-tax-term\">Competitive landscape<\/span>","<span class=\"advgb-post-tax-term\">DelveInsight<\/span>","<span class=\"advgb-post-tax-term\">Keytruda<\/span>","<span class=\"advgb-post-tax-term\">licensing opportunities<\/span>","<span class=\"advgb-post-tax-term\">market trends<\/span>","<span class=\"advgb-post-tax-term\">Novo Nordisk<\/span>","<span class=\"advgb-post-tax-term\">Oncology<\/span>","<span class=\"advgb-post-tax-term\">Research and Development<\/span>","<span class=\"advgb-post-tax-term\">Roche<\/span>","<span class=\"advgb-post-tax-term\">Tecentriq<\/span>","<span class=\"advgb-post-tax-term\">technology assessments<\/span>","<span class=\"advgb-post-tax-term\">USFDA<\/span>","<span class=\"advgb-post-tax-term\">Victoza<\/span>","<span class=\"advgb-post-tax-term\">Xarelto<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Oct 10, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Oct 10, 2017 5:51 pm","modified":"Updated on Jul 24, 2021 12:56 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