{"id":2448,"date":"2017-12-05T18:07:51","date_gmt":"2017-12-05T12:37:51","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2448"},"modified":"2021-07-24T12:56:53","modified_gmt":"2021-07-24T07:26:53","slug":"notizia-59","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-59","title":{"rendered":"KINECT 4 Study; KindredBio Announces Results; Mylan and Aspen\u2019s Launch; EMA investigates; Amgen\u2019s Repatha"},"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-69fa48bfc16dd\" 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-69fa48bfc16dd\"  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-59\/#KINECT_4_Phase_III_Study_Demonstrating_INGREZZA%C2%AE_Improves_Tardive_Dyskinesia_Symptoms\" >KINECT 4 Phase III Study Demonstrating INGREZZA\u00ae Improves Tardive Dyskinesia Symptoms<\/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-59\/#KindredBio_Announces_Positive_Results_from_Pivotal_Study_of_Zimeta_Oral_for_Fever_in_Horses\" >KindredBio Announces Positive Results from Pivotal Study of Zimeta Oral for Fever in Horses<\/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-59\/#Mylan_and_Aspen_Announce_Launch_of_Generic_Busulfex%C2%AE_Injection\" >Mylan and Aspen Announce Launch of Generic Busulfex\u00ae Injection<\/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-59\/#EMA_investigates_Allergan_blockbuster_hopeful_Esmya_on_reports_of_liver_damage\" >EMA investigates Allergan blockbuster hopeful Esmya on reports of liver damage<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-59\/#Amgen_gets_its_shot_at_promoting_Repatha_to_prevent_heart_attacks_and_strokes\" >Amgen gets its shot at promoting Repatha to prevent heart attacks and strokes<\/a><\/li><\/ul><\/nav><\/div>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"KINECT_4_Phase_III_Study_Demonstrating_INGREZZA%C2%AE_Improves_Tardive_Dyskinesia_Symptoms\"><\/span>KINECT 4 Phase III Study Demonstrating INGREZZA\u00ae Improves Tardive Dyskinesia Symptoms<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Neurocrine Biosciences, Inc. announced new long-term data from the KINECT 4 Phase III open-label study demonstrate that once-daily INGREZZA\u00ae (valbenazine) capsules, the first FDA approved treatment for adults with tardive dyskinesia (TD), improved TD symptoms through 48 weeks of open-label treatment and was generally well tolerated. TD is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and\/or face. These data were presented at the ACNP Annual Meeting. In addition to the KINECT 4 Phase III study results, Neurocrine also presented pooled data analyses from three double-blind, placebo-controlled INGREZZA studies (KINECT, KINECT 2 and KINECT 3) across patient sub-groups. Pooled data analyses showed that once-daily INGREZZA improved tardive dyskinesia symptoms and was generally well tolerated in both older and younger adults.<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"KindredBio_Announces_Positive_Results_from_Pivotal_Study_of_Zimeta_Oral_for_Fever_in_Horses\"><\/span>KindredBio Announces Positive Results from Pivotal Study of Zimeta Oral for Fever in Horses<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Kindred Biosciences, a biopharmaceutical company focused on saving and improving the lives of pets, announced positive topline results from its pivotal field effectiveness study of Zimeta&#x2122; (dipyrone oral gel) for the control of pyrexia (fever) in horses. This study was a multicenter, randomized, blinded, placebo-controlled pivotal study that enrolled 139 horses to assess the effectiveness of Zimeta Oral. The primary endpoint was improvement or resolution of fever 6 hours after treatment. The success rate was approximately 78% in the Zimeta Oral group vs. approximately 18% in the placebo group.\u00a0 Based on preliminary review of the safety data, the drug appears to be well tolerated. KindredBio has completed the in-life portion of the Target Animal Safety Study and is analyzing the data. The Company anticipates submitting the Effectiveness technical section of the New Animal Drug Application in early 2018, and the Safety and Chemistry, Manufacturing and Controls technical sections in the first half of 2018.<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Mylan_and_Aspen_Announce_Launch_of_Generic_Busulfex%C2%AE_Injection\"><\/span>Mylan and Aspen Announce Launch of Generic Busulfex\u00ae Injection<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Mylan and its partner, Aspen, announced the U.S. launch of Myleran (busulfan) Injection, 60 mg\/10 mL (6 mg\/mL) Single-dose Vial, a generic version of Otsuka Pharmaceutical&#8217;s Busulfex\u00ae Injection. Aspen received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. As part of its partnership with Aspen, Mylan will commercialize Busulfan Injection, 60 mg\/10 mL (6 mg\/mL) Single-dose Vial in the U.S. Mylan has one of the largest injectable portfolios in the industry and is also one of the largest suppliers of cancer medicines by volume in the U.S. U.S. sales for Busulfan Injection, 60 mg\/10 mL (6 mg\/mL) Single-dose Vial were approximately $97 million for the 12 months ending Sept. 30, 2017.<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"EMA_investigates_Allergan_blockbuster_hopeful_Esmya_on_reports_of_liver_damage\"><\/span>EMA investigates Allergan blockbuster hopeful Esmya on reports of liver damage<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">As Allergan chases a U.S. approval for uterine fibroids drug Esmya, across the pond, regulators are investigating the treatment for liver damage. The European Medicines Agency\u2019s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has launched a review of the product after four cases of serious liver damage turned up among patients, Bernstein\u2019s Ronny Gal wrote in a note to clients. Three of those cases ended in liver transplantation. Allergan, for its part, does not expect the investigation will have an impact on its New Drug Application, while the product\u2019s ability to reach blockbuster heights\u2014as Allergan insists it can\u2014depends on the label\u2019s breadth.<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Amgen_gets_its_shot_at_promoting_Repatha_to_prevent_heart_attacks_and_strokes\"><\/span>Amgen gets its shot at promoting Repatha to prevent heart attacks and strokes<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Amgen has its long-awaited approval to tout Repatha as a cardiovascular prevention tool. On the basis of a massive CV outcomes trial unveiled in March, the FDA blessed the cholesterol drug to fend off heart attacks, strokes and coronary revascularization surgeries in patients with heart disease. In that trial, called Fourier, Repatha reduced heart attack risks by 27%, stroke risks by 21% and coronary revascularizations by 22%. With the FDA approval, Repatha becomes the first in its class of pricey new cholesterol drugs to boast the indication. Amgen has rolled out its economic analyses, including an August report based on the mash-up of Fourier data and real-world numbers. That analysis showed Repatha is cost-effective at $9,669 per year or less\u2014an amount consistent with what&#8217;s generally paid after rebates and discounts.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>KINECT 4 Phase III Study Demonstrating INGREZZA\u00ae Improves Tardive Dyskinesia Symptoms Neurocrine Biosciences, Inc. announced new long-term data from the KINECT 4 Phase III open-label study demonstrate that once-daily INGREZZA\u00ae (valbenazine) capsules, the first FDA approved treatment for adults with tardive dyskinesia (TD), improved TD symptoms through 48 weeks of open-label treatment and was generally [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2303,"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":[70,831,1223,1168,134,1224,1155,204,709,1226,1228,1218,1225,1221,1217,1227,412,730,1204,1205,1229,1219,1220,1222],"industry":[17225],"therapeutic_areas":[17245,17228],"class_list":["post-2448","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-allergan","tag-amgen","tag-aspen","tag-business-consultancy","tag-business-consultant","tag-busulfex","tag-consultancy","tag-delveinsight","tag-ema","tag-esmya","tag-european-medicines-agencys","tag-ingrezza","tag-injection","tag-kindredbio","tag-kinect-4","tag-liver-damage","tag-mylan","tag-notizia","tag-pharma-reports","tag-pharmaceutical-reports","tag-repatha","tag-tardive-dyskinesia","tag-valbenazine","tag-zimeta-oral","industry-pharmaceutical","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\">Allergan<\/a>","<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\">Aspen<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">business consultancy<\/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\">Busulfex<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">consultancy<\/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\">EMA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Esmya<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">European Medicines Agency\u2019s<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">INGREZZA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Injection<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">KindredBio<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">KINECT 4<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">liver damage<\/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\">Notizia<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pharma reports<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pharmaceutical reports<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Repatha<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Tardive Dyskinesia<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">valbenazine<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Zimeta Oral<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Allergan<\/span>","<span class=\"advgb-post-tax-term\">Amgen<\/span>","<span class=\"advgb-post-tax-term\">Aspen<\/span>","<span class=\"advgb-post-tax-term\">business consultancy<\/span>","<span class=\"advgb-post-tax-term\">Business Consultant<\/span>","<span class=\"advgb-post-tax-term\">Busulfex<\/span>","<span class=\"advgb-post-tax-term\">consultancy<\/span>","<span class=\"advgb-post-tax-term\">DelveInsight<\/span>","<span class=\"advgb-post-tax-term\">EMA<\/span>","<span class=\"advgb-post-tax-term\">Esmya<\/span>","<span class=\"advgb-post-tax-term\">European Medicines Agency\u2019s<\/span>","<span class=\"advgb-post-tax-term\">INGREZZA<\/span>","<span class=\"advgb-post-tax-term\">Injection<\/span>","<span class=\"advgb-post-tax-term\">KindredBio<\/span>","<span class=\"advgb-post-tax-term\">KINECT 4<\/span>","<span class=\"advgb-post-tax-term\">liver damage<\/span>","<span class=\"advgb-post-tax-term\">Mylan<\/span>","<span class=\"advgb-post-tax-term\">Notizia<\/span>","<span class=\"advgb-post-tax-term\">pharma reports<\/span>","<span class=\"advgb-post-tax-term\">pharmaceutical reports<\/span>","<span class=\"advgb-post-tax-term\">Repatha<\/span>","<span class=\"advgb-post-tax-term\">Tardive Dyskinesia<\/span>","<span class=\"advgb-post-tax-term\">valbenazine<\/span>","<span class=\"advgb-post-tax-term\">Zimeta Oral<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 8 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Dec 5, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Dec 5, 2017 6:07 pm","modified":"Updated on Jul 24, 2021 12:56 pm"},"featured_img_caption":"","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/2448","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=2448"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/2448\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/2303"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=2448"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=2448"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=2448"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=2448"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=2448"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}