{"id":2053,"date":"2017-04-12T12:06:47","date_gmt":"2017-04-12T12:06:47","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2053"},"modified":"2021-07-24T12:56:44","modified_gmt":"2021-07-24T07:26:44","slug":"notizia-34","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-34","title":{"rendered":"Dengvaxia study; Opdivo racks up; FDA issues plant; Teva&#8217;s Rimsa fraud; Mission bags Fox 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-6a052ed8926fb\" 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-6a052ed8926fb\"  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-34\/#Malaysia_calls_for_phase_4_Dengvaxia_study_before_considering_full_approval\" >Malaysia calls for phase 4 Dengvaxia study before considering full approval<\/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-34\/#Bristol-Myers_Opdivo_racks_up_latest_NICE_rejection_this_time_in_head_and_neck_cancer\" >Bristol-Myers&#8217; Opdivo racks up latest NICE rejection, this time in head and neck cancer<\/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-34\/#FDA_issues_another_Mylan_plant_in_India_a_warning_letter\" >FDA issues another Mylan plant in India a warning letter<\/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-34\/#Mexican_regulator_undermines_Tevas_Rimsa_fraud_claims_with_%E2%80%98all_clear_memorandum\" >Mexican regulator undermines Teva&#8217;s Rimsa fraud claims with &#8216;all clear&#8217; memorandum<\/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-34\/#Mission_bags_Fox_Foundation_grant_for_Parkinsons_program\" >Mission bags Fox Foundation grant for Parkinson\u2019s program<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Malaysia_calls_for_phase_4_Dengvaxia_study_before_considering_full_approval\"><\/span>Malaysia calls for phase 4 Dengvaxia study before considering full approval<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Already struggling to meet initial expectations, Sanofi Pasteur&#8217;s dengue vaccine Dengvaxia will have to undergo phase 4 testing in Malaysia before the endemic country agrees to sign off on a full approval. Malaysia\u2019s National Pharmaceutical Regulatory Agency\u2019s Drug Control Authority, which conditionally approved the vaccine, said in a notice that if the study fails to verify the clinical benefit, DCA may withdraw Dengvaxia&#8217;s registration. The French vaccine maker will conduct the two-year trial jointly with the country\u2019s Ministry of Health, aiming to further assess the vaccine\u2019s effectiveness and safety. Before the readout, the vaccine will only be available to eligible trial volunteers 9 to 45 years old. It won&#8217;t be covered by Malaysia\u2019s National Immunisation Programme, meaning that participants will need to pay to get vaccinated.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Bristol-Myers_Opdivo_racks_up_latest_NICE_rejection_this_time_in_head_and_neck_cancer\"><\/span>Bristol-Myers&#8217; Opdivo racks up latest NICE rejection, this time in head and neck cancer<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Bristol-Myers Squibb\u2019s Opdivo hasn\u2019t even won marketing approval for head and neck cancer in England and Wales yet, but their cost watchdog is already shutting it out. The National Institute for Health and Care Excellence on Tuesday introduced the latest in a series of setbacks for the BMS immuno-oncology hotshot: draft guidance that doesn\u2019t recommend it as a head and neck cancer therapy. The med\u2019s costs\u2014\u00a3439 per 40-mg vial and \u00a31,097 per 100-mg vial, less a confidential discount agreed to with Bristol-Myers\u2014\u201cwere considered to be very high in relation to its benefit to be recommended for routine NHS use at present,\u201d Carole Longson, director of NICE\u2019s health technology evaluation center.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"FDA_issues_another_Mylan_plant_in_India_a_warning_letter\"><\/span>FDA issues another Mylan plant in India a warning letter<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Less than two years after being given a warning letter by the FDA for problems at three plants it got in its buyout of a sterile injectables specialist Agila Specialties, another Mylan plant in India has been issued a warning letter for ongoing data integrity issues. In the warning letter, issued last week and posted by the FDA today, the agency said investigators continued to find issues with batch testing results disappearing from computers when failed tests were involved. The observations were based on an inspection of the finished pharmaceutical plant in Maharashtra, India. It noted that even though the facility invalidated 101 of 139 initial out-of-specification (OOS) assay results, about 72%, employees never thoroughly investigated to find the root cause of the issues and didn\u2019t include them in the results reported to the agency.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Mexican_regulator_undermines_Tevas_Rimsa_fraud_claims_with_%E2%80%98all_clear_memorandum\"><\/span>Mexican regulator undermines Teva&#8217;s Rimsa fraud claims with &#8216;all clear&#8217; memorandum<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Teva contends that Mexican generics buy Rimsa sold defective, illegal products and lied about it, duping not only itself as buyer, but regulators and the public as well. But a new memorandum from Mexico\u2019s drug watchdog doesn&#8217;t help its case. According to a March 13 document seen by The Times of Israel, Mexico\u2019s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) found no \u201cunexpected adverse effects\u201d among Rimsa\u2019s 147 products and has located authorization for all of them within its archives. Sixteen COFEPRIS checks on Rimsa dating back to 2009 also failed to turn up any issues that could pose health risks, and the body found documentation provided by Rimsa to be \u201ctruthful and correct.&#8221; The conclusions don\u2019t exactly support Teva\u2019s legal claims that Rimsa withheld discrepancies between manufacturing processes and descriptions in product registrations filed with regulators.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Mission_bags_Fox_Foundation_grant_for_Parkinsons_program\"><\/span>Mission bags Fox Foundation grant for Parkinson\u2019s program<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Mission Therapeutics and the University of Oxford have landed a grant to fund testing of USP30 inhibitors. The Michael J. Fox Foundation for Parkinson\u2019s Research (MJFF) is putting up the money to enable Mission to test its USP30 inhibitors in stem cell-derived Parkinson\u2019s disease models. MJFF is funding the research in an attempt to validate USP30 as a target for the treatment of Parkinson\u2019s. By inhibiting USP30 in malfunctioning mitochondria, the scientists stand to show whether the therapeutic approach may improve the operation of the organelles and neuron health. And there is an expectation this will enable the identification of biomarkers of USP30 that will prove useful in subsequent clinical development.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Malaysia calls for phase 4 Dengvaxia study before considering full approval Already struggling to meet initial expectations, Sanofi Pasteur&#8217;s dengue vaccine Dengvaxia will have to undergo phase 4 testing in Malaysia before the endemic country agrees to sign off on a full approval. Malaysia\u2019s National Pharmaceutical Regulatory Agency\u2019s Drug Control Authority, which conditionally approved the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1247,"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":[17509,634,704,412,420,431,450,1826,712,639],"industry":[17225],"therapeutic_areas":[17231,17245,17228],"class_list":["post-2053","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-dengvaxia","tag-drug-development","tag-fda","tag-mylan","tag-news","tag-opdivo","tag-parkinsons","tag-parkinsons-disease","tag-pharma-industry","tag-pharma-news","industry-pharmaceutical","therapeutic_areas-infectious-diseases","therapeutic_areas-neurology","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\">Dengvaxia<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">drug development<\/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\">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\">Opdivo<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Parkinson\u2019s<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Parkinson\u2019s disease<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Pharma Industry<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pharma news<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Dengvaxia<\/span>","<span class=\"advgb-post-tax-term\">drug development<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">Mylan<\/span>","<span class=\"advgb-post-tax-term\">news<\/span>","<span class=\"advgb-post-tax-term\">Opdivo<\/span>","<span class=\"advgb-post-tax-term\">Parkinson\u2019s<\/span>","<span class=\"advgb-post-tax-term\">Parkinson\u2019s disease<\/span>","<span class=\"advgb-post-tax-term\">Pharma Industry<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Apr 12, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Apr 12, 2017 12:06 pm","modified":"Updated on Jul 24, 2021 12:56 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