{"id":2209,"date":"2017-07-11T20:57:56","date_gmt":"2017-07-11T15:27:56","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2209"},"modified":"2023-02-10T11:19:33","modified_gmt":"2023-02-10T05:49:33","slug":"notizia-46","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-46","title":{"rendered":"Gilead faces lawsuit; Herceptin stalled; Lilly revs up, Abemaciclib gets nod; Key Humira patent gets struck down"},"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-69f7ec29adc83\" 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-69f7ec29adc83\"  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-46\/#Gilead_faces_revived_lawsuit_claiming_it_sidestepped_FDA_with_HIV_drug_imports\" >Gilead faces revived lawsuit claiming it sidestepped FDA with HIV drug imports<\/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-46\/#Biocon_and_Mylan_Herceptin_biosimilar_stalled_in_EU_over_plant_issues\" >Biocon and Mylan Herceptin biosimilar stalled in EU over plant issues<\/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-46\/#Lilly_revs_up_to_challenge_Pfizer_Novartis_in_breast_cancer_with_abemaciclib_%E2%80%98priority_nod\" >Lilly revs up to challenge Pfizer, Novartis in breast cancer with abemaciclib &#8216;priority&#8217; nod<\/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-46\/#Key_Humira_patent_gets_struck_down_for_the_second_time_in_as_many_months\" >Key Humira patent gets struck down for the second time in as many months<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Gilead_faces_revived_lawsuit_claiming_it_sidestepped_FDA_with_HIV_drug_imports\"><\/span>Gilead faces revived lawsuit claiming it sidestepped FDA with HIV drug imports<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Gilead Sciences thought it had prevailed in a whistleblower lawsuit alleging it circumvented FDA rules to use a China-made active ingredient in three top HIV meds, rather than a higher-priced version from South Korea that the agency had approved. But now the California-based drugmaker has to think again. An appeals court revived that lawsuit, remanding it back to District Court. In a new opinion (PDF), the U.S. Court of Appeals for the Ninth Circuit revived the False Claims Act lawsuit against Gilead brought on behalf of the government by ex-employees Jeff and Sherilyn Campie. The Campies allege Gilead hid the fact that it contracted with a Chinese manufacturer to make the active ingredient in HIV meds Emtriva, Truvada and Atripla.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Biocon_and_Mylan_Herceptin_biosimilar_stalled_in_EU_over_plant_issues\"><\/span>Biocon and Mylan Herceptin biosimilar stalled in EU over plant issues<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Mylan and Biocon, which had expected to be first to market with a Herceptin biosimilar in Europe, have hit a stumbling block that could delay their bid and give Roche some breathing room before copies take a bite out of its $2 billion in sales there. Biocon said (PDF) in a filing Sunday that the European Medicines Agency found issues with its product plant in Banglore and has told them a follow-up inspection will be required to insure Biocon implemented changes before the EMA will give it a thumbs up. The Indian drugmaker said the EMA had reviewed its \u201ccorrective action\u201d plan and that work was progressing following a March review by French inspectors. Two API plants that will provide ingredients were approved. \u201cBiocon, with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow-up inspection of the drug product facility and the Marketing Authorization Applications with the goal of an early reinspection,\u201d the company said in its statement.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Lilly_revs_up_to_challenge_Pfizer_Novartis_in_breast_cancer_with_abemaciclib_%E2%80%98priority_nod\"><\/span>Lilly revs up to challenge Pfizer, Novartis in breast cancer with abemaciclib &#8216;priority&#8217; nod<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">On Monday, the FDA granted Eli Lilly\u2019s abemaciclib a priority review, putting it on a quicker path to approval. If it can get there, it\u2019ll become the third entrant in the CDK 4\/6 class of breast-cancer fighters, behind Ibrance and Novartis\u2019 Kisqali\u2014a medication the agency greenlighted less than four months ago Of course, abemaciclib will have its challenges as a third-to-market med\u2014but it\u2019s facing other hurdles, too. It\u2019s triggered frequent, low-grade diarrhea in trials, a side effect that\u2019s \u201cnot the kind of differentiation a manufacturer seeks,\u201d as Bernstein analyst Tim Anderson put it in an April note to clients. But as Barclays analyst Geoff Meacham pointed out in his own June note, adjusting dosage is an option for dealing with the diarrhea rates\u2014though it remains to be seen if doing so \u201cwill be enough to spur greater than expected utilization.\u201d<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Key_Humira_patent_gets_struck_down_for_the_second_time_in_as_many_months\"><\/span>Key Humira patent gets struck down for the second time in as many months<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">A little less than two months after Coherus BioSciences succeeded in upturning a key IP shield on AbbVie\u2019s Humira, yet another company seeking to launch a biosimilar rival to the blockbuster rheumatoid arthritis drug has scored the same victory. On Thursday, after an inter partes review (IPR), the U.S. Patent and Trademark Office\u2019s Patent Trial and Appeal Board (PTAB) ruled in favor of Boehringer Ingelheim in a case that challenged five claims for the \u2018135 methods patent on Humira. The \u2018135 patent is considered important because it covers the dosing and treatment frequency of the drug\u2014which any biosimilar developer will need in order to win FDA approval of a biosimilar drug.&nbsp; The ruling follows a May IPR win for Coherus that struck down the same patent. But BI&#8217;s success could make it more difficult for AbbVie to overturn the PTAB&#8217;s rulings; now, AbbVie will have to appeal both decisions, which it said in an emailed statement that it plans to do.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gilead faces revived lawsuit claiming it sidestepped FDA with HIV drug imports Gilead Sciences thought it had prevailed in a whistleblower lawsuit alleging it circumvented FDA rules to use a China-made active ingredient in three top HIV meds, rather than a higher-priced version from South Korea that the agency had approved. But now the California-based [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1991,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":2,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[1317,228,794,900,412,420,639,2019],"industry":[17225],"therapeutic_areas":[17227,17228],"class_list":["post-2209","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-biocon","tag-eli-lilly","tag-gilead","tag-humira","tag-mylan","tag-news","tag-pharma-news","tag-rheumatoid-arthritis","industry-pharmaceutical","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the 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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\">Biocon<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Eli Lilly<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Gilead<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Humira<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Mylan<\/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\">rheumatoid arthritis<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Biocon<\/span>","<span class=\"advgb-post-tax-term\">Eli Lilly<\/span>","<span class=\"advgb-post-tax-term\">Gilead<\/span>","<span class=\"advgb-post-tax-term\">Humira<\/span>","<span class=\"advgb-post-tax-term\">Mylan<\/span>","<span class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>","<span class=\"advgb-post-tax-term\">rheumatoid arthritis<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 3 years ago"},"absolute_dates":{"created":"Posted on Jul 11, 2017","modified":"Updated on Feb 10, 2023"},"absolute_dates_time":{"created":"Posted on Jul 11, 2017 8:57 pm","modified":"Updated on Feb 10, 2023 11:19 am"},"featured_img_caption":"","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/2209","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=2209"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/2209\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/1991"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=2209"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=2209"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=2209"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=2209"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=2209"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}