{"id":2128,"date":"2017-05-16T17:01:08","date_gmt":"2017-05-16T11:31:08","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2128"},"modified":"2021-07-24T12:56:46","modified_gmt":"2021-07-24T07:26:46","slug":"notizia-39","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-39","title":{"rendered":"Novartis, slammed by Korean scandal; FDA tweaks; Dendreon eyes; Amgen adds"},"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-6a094c5e7b965\" 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-6a094c5e7b965\"  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-39\/#Novartis_slammed_by_Korean_scandal_tweaks_its_ethics_compliance_policies\" >Novartis, slammed by Korean scandal, tweaks its ethics, compliance policies<\/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-39\/#Chinas_latest_Western-style_FDA_tweak_puts_orphan_drug_approvals_in_the_fast_lane\" >China&#8217;s latest Western-style FDA tweak puts orphan drug approvals in the fast lane<\/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-39\/#Dendreon_eyes_real-world_data_boost_for_lagging_prostate_cancer_med_Provenge\" >Dendreon eyes real-world data boost for lagging prostate cancer med Provenge<\/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-39\/#Amgen_adds_online_cancer_team_narratives_to_Neulasta_Onpro_push\" >Amgen adds online cancer team narratives to Neulasta Onpro push<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Novartis_slammed_by_Korean_scandal_tweaks_its_ethics_compliance_policies\"><\/span>Novartis, slammed by Korean scandal, tweaks its ethics, compliance policies<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Rocked by a corruption scandal in Korea and facing a kickbacks probe in Greece, Novartis says it&#8217;s strengthening and simplifying its global ethics and compliance approach. The Swiss drug giant is aiming to shift from policing to coaching, with a compliance unit focused on helping local units make the right decisions. Novartis also wants to simplify its policies so they are easy to understand. Last month, Korean authorities handed out a $50 million fine and suspended coverage on several Novartis meds in relation to a bribery probe in the country. Novartis employees conducted a kickbacks scheme through medical journal-sponsored meetings, with the total spent on bribes estimated to be $2.3 million, according to officials.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Chinas_latest_Western-style_FDA_tweak_puts_orphan_drug_approvals_in_the_fast_lane\"><\/span>China&#8217;s latest Western-style FDA tweak puts orphan drug approvals in the fast lane<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">China&#8217;s FDA, long criticized for its cumbersome and slow drug-review process, is offering to grant conditional OKs for orphan meds already approved abroad, even without in-China trial data. The new orphan drug move is one in a series of new proposals posted online May 11. China\u2019s FDA is once again planning major changes to its clinical trial and drug approval policies, further aligning them with its Western counterparts. A key feature is the new \u201cconditional marketing authorization\u201d for orphan meds. The CFDA is offering (Chinese) to grant conditional approval for meds that treat life-threatening conditions where significant unmet medical needs exist, if early- or mid-stage data can predict the drugs\u2019 clinical benefits. This policy resembles the EMA&#8217;s \u201cconditional marketing authorization\u201d and the U.S. FDA\u2019s \u201cbreakthrough therapy\u201d program, which itself is just short of 5 years old.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Dendreon_eyes_real-world_data_boost_for_lagging_prostate_cancer_med_Provenge\"><\/span>Dendreon eyes real-world data boost for lagging prostate cancer med Provenge<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Years after winning a hotly anticipated FDA approval for its cancer immunotherapy Provenge\u2014and struggling to build sales of the prostate cancer med\u2014Dendreon has racked up some real-world survival data it hopes can help. At the American Urologic Association\u2019s annual meeting, the company presented real-world findings showing a survival benefit especially pronounced in African American patients with metastatic castrate-resistant prostate cancer (mCPRC). African-American Provenge patients lived a median 37.3 months after treatment compared with 28 months after treatment for Caucasian patients. The data were consistent with the clinical trials Dendreon used to win Provenge approval back in 2010, according to the company, bought out by China&#8217;s Sanpower last year.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Amgen_adds_online_cancer_team_narratives_to_Neulasta_Onpro_push\"><\/span>Amgen adds online cancer team narratives to Neulasta Onpro push<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Cancer patients and their care teams are taking center stage in Amgen&#8217;s newest online campaign. The Neulasta Onpro effort, dubbed Neulasta Onpro Narratives, highlights patients\u2019 and professionals\u2019 cancer stories to encourage conversations, specifically about the risk of infection from low white blood cell counts\u2014a risk Neulasta is approved to reduce. Sharing the personal experiences can help raise awareness and encourage patients to discuss the potential risk with their healthcare professional, as per company sources. The online campaign comes just over a year into Amgen\u2019s first Neulasta Onpro-specific TV ad, titled &#8220;Support at Home,&#8221; which began running last March. Amgen has spent more than $38 million on national TV airings of the ad, according to data from real-time TV ad tracker iSpot.tv. The Onpro DTC campaign includes similarly themed print ads.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Novartis, slammed by Korean scandal, tweaks its ethics, compliance policies Rocked by a corruption scandal in Korea and facing a kickbacks probe in Greece, Novartis says it&#8217;s strengthening and simplifying its global ethics and compliance approach. The Swiss drug giant is aiming to shift from policing to coaching, with a compliance unit focused on helping [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1957,"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":[831,895,894,17523,423,498,17522,814],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-2128","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-amgen","tag-china-orphan-drug","tag-dendreon","tag-neulasta","tag-novartis","tag-prostate-cancer","tag-provenge","tag-south-korea","industry-pharmaceutical","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\">Amgen<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">China orphan drug<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Dendreon<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Neulasta<\/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\">Prostate Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Provenge<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">South Korea<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Amgen<\/span>","<span class=\"advgb-post-tax-term\">China orphan drug<\/span>","<span class=\"advgb-post-tax-term\">Dendreon<\/span>","<span class=\"advgb-post-tax-term\">Neulasta<\/span>","<span class=\"advgb-post-tax-term\">Novartis<\/span>","<span class=\"advgb-post-tax-term\">Prostate Cancer<\/span>","<span class=\"advgb-post-tax-term\">Provenge<\/span>","<span class=\"advgb-post-tax-term\">South Korea<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on May 16, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on May 16, 2017 5:01 pm","modified":"Updated on Jul 24, 2021 12:56 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