{"id":1584,"date":"2016-11-29T12:01:46","date_gmt":"2016-11-29T12:01:46","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=1584"},"modified":"2021-07-24T12:56:35","modified_gmt":"2021-07-24T07:26:35","slug":"notizia-16","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-16","title":{"rendered":"EC grants; Pfizer cuts; 27 medicines sold; Keytruda nabs"},"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-69fa674fb48fd\" 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-69fa674fb48fd\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-16\/#EC_grants_marketing_authorisation_for_Takedas_Ninlaro_capsules\" >EC grants marketing authorisation for Takeda\u2019s Ninlaro capsules<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-16\/#Pfizer_cuts_E400M_plant_expansion_after_dumping_cholesterol-lowering_drug_program\" >Pfizer cuts \u20ac400M plant expansion after dumping cholesterol-lowering drug program<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-16\/#Drug_regulation_27_medicines_sold_by_top_firms_%E2%80%98fail_quality_tests\" >Drug regulation: 27 medicines sold by top firms \u2018fail\u2019 quality tests<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-16\/#Mercks_Keytruda_nabs_FDAs_%E2%80%98priority_tag_in_microsatellite_instability-high_cancer\" >Merck&#8217;s Keytruda nabs FDA&#8217;s &#8216;priority&#8217; tag in microsatellite instability-high cancer<\/a><\/li><\/ul><\/nav><\/div>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"EC_grants_marketing_authorisation_for_Takedas_Ninlaro_capsules\"><\/span>EC grants marketing authorisation for Takeda\u2019s Ninlaro capsules<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">The European Commission (EC) has granted conditional marketing authorisation for Takeda Pharmaceutical\u2019s Ninlaro capsules. The oral proteasome inhibitor is indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have previously received at least one therapy. The EC\u2019s decision was based on data from the pivotal Phase III Tourmaline-MM1 trial, which showed that the capsule with lenalidomide and dexamethasone increased the length of progression-free survival by about 40% in patients with relapsed and refractory multiple myeloma.<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Pfizer_cuts_E400M_plant_expansion_after_dumping_cholesterol-lowering_drug_program\"><\/span>Pfizer cuts \u20ac400M plant expansion after dumping cholesterol-lowering drug program<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Pfizer is dumping much of the \u20ac400 million plant expansion in Ireland it was planning to support it. With the decision not to proceed with the pro-protein convertase subtilisin\/kexin type 9 inhibitor (PCSK9i) bococizumab, the New York drug maker will not need the 371,300-square-foot expansion of its Grange Castle biologics manufacturing unit or the 300 or so jobs that would have brought. Following the decision to discontinue the development of bococizumab, part of the potential expansion for which the planning permission was sought will not go ahead. Expansion in relation to other incoming products will continue as planned, involving investment, recruitment and new technology.<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Drug_regulation_27_medicines_sold_by_top_firms_%E2%80%98fail_quality_tests\"><\/span>Drug regulation: 27 medicines sold by top firms \u2018fail\u2019 quality tests<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">In a\u00a0major crackdown since March this year, drug regulators of seven states have alleged that 27 medicines \u2014 sold by 18 major drug companies in India \u2014 are of \u201csubstandard\u201d quality, citing grounds such as false labelling, wrong quantity of ingredients, discoloration, moisture formation, failing dissolution test and failing disintegration test. Some of the key brands which were alleged to be substandard are: antipsychotic drug Stemetil and antibiotic drug Pentids from Abbott India; anti-bacterial medicine Althrocin by Alembic Pharma; migraine medication Vasograin by Cadila Pharma; popular cough syrup Ascoril by Glenmark Pharma; worm infection drug Zentel by GSK India; arthritis medication <a href=\"https:\/\/www.delveinsight.com\/report-store\/hydroxychloroquine-drug-insights\">Hydroxychloroquine<\/a> (HCQS) by Ipca Labs; anti-inflammatory medication Myoril by Sanofi Synthelabo; and Torrent Pharma\u2019s hypertension drug Dilzem.<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Mercks_Keytruda_nabs_FDAs_%E2%80%98priority_tag_in_microsatellite_instability-high_cancer\"><\/span>Merck&#8217;s Keytruda nabs FDA&#8217;s &#8216;priority&#8217; tag in microsatellite instability-high cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">The immuno-oncology med has taken the spotlight back with a priority review tag from the FDA. Merck\u2019s Keytruda isn\u2019t letting rival Opdivo from Bristol-Myers Squibb soak up all the November regulatory attention. The agency doled out the distinction to Keytruda for the treatment of previously treated patients with advanced microsatellite instability-high cancer, the New Jersey pharma giant said on Monday, and it should speed the med\u2019s path down the regulatory pathway. If Keytruda ultimately snags an approval, Merck will add it to the list of indications its budding star already boasts in melanoma, non-small cell lung cancer and head-and-neck cancer. Microsatellite instability-high cancer is an area where Merck\u2019s competitors haven\u2019t yet hit the market, meaning it\u2019s an opportunity to build a lead.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EC grants marketing authorisation for Takeda\u2019s Ninlaro capsules The European Commission (EC) has granted conditional marketing authorisation for Takeda Pharmaceutical\u2019s Ninlaro capsules. The oral proteasome inhibitor is indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have previously received at least one therapy. The EC\u2019s decision was based on data [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":941,"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":[2867,704,903,345,395,410,17412,460,554],"industry":[17225],"therapeutic_areas":[17240,17228,17234],"class_list":["post-1584","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-cholesterol","tag-fda","tag-gsk","tag-keytruda","tag-merck","tag-multiple-myeloma","tag-ninlaro","tag-pfizer","tag-takeda","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-oncology","therapeutic_areas-rare-diseases"],"acf":[],"yoast_head":"<!-- This site is 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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\">cholesterol<\/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\">GSK<\/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\">Merck<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Multiple Myeloma<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Ninlaro<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Pfizer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Takeda<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">cholesterol<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">GSK<\/span>","<span class=\"advgb-post-tax-term\">Keytruda<\/span>","<span class=\"advgb-post-tax-term\">Merck<\/span>","<span class=\"advgb-post-tax-term\">Multiple Myeloma<\/span>","<span class=\"advgb-post-tax-term\">Ninlaro<\/span>","<span class=\"advgb-post-tax-term\">Pfizer<\/span>","<span class=\"advgb-post-tax-term\">Takeda<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Nov 29, 2016","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Nov 29, 2016 12:01 pm","modified":"Updated on Jul 24, 2021 12:56 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