{"id":3143,"date":"2018-09-04T12:08:47","date_gmt":"2018-09-04T06:38:47","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=3143"},"modified":"2021-07-24T12:57:03","modified_gmt":"2021-07-24T07:27:03","slug":"notizia-71","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-71","title":{"rendered":"Notizia"},"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-69fca099cb12c\" 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-69fca099cb12c\"  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-71\/#Food_and_Drug_Administration_repudiates_ADHD_drug_by_Sunovion\" >Food and Drug Administration repudiates ADHD drug by Sunovion<\/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-71\/#Food_and_Drug_Administration_backs_Shires_Takhzyro_for_Hereditary_Angioedema\" >Food and Drug Administration backs Shire\u2019s Takhzyro for Hereditary Angioedema<\/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-71\/#Merck_receives_Food_and_Drug_Administration_approval_for_its_two_new_drugs\" >Merck receives Food and Drug Administration approval for its two new drugs<\/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-71\/#Food_and_Drug_Administration_commences_pilot_to_aid_sponsors_use_novel_trial_designs\" >Food and Drug Administration commences pilot to aid sponsors use novel trial designs<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Food_and_Drug_Administration_repudiates_ADHD_drug_by_Sunovion\"><\/span><strong>Food and Drug Administration repudiates ADHD drug by Sunovion<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Sunovion\u2019s ADHD drug for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/attention-deficit-hyperactivity-disorder-adhd-market\">attention-deficit hyperactivity disorder<\/a> (ADHD) has not been accepted by the Food and Drug Administration, FDA. It is so because the drug for ADHD treatment in its current form needs additional clinical trials and data for accessing the efficacy and tolerability of dasotraline. The drug is a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI). Sunovion is slated to meet the Food and Drug Administration for discussing the problems.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Food_and_Drug_Administration_backs_Shires_Takhzyro_for_Hereditary_Angioedema\"><\/span><strong>Food and Drug Administration backs Shire\u2019s Takhzyro for Hereditary Angioedema<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The\u00a0<strong style=\"font-style: inherit;\">U.S.\u00a0<\/strong><strong>Food and Drug Administration<\/strong>\u00a0accepted\u00a0Shire\u2019s Takhzyro (lanadelumab-flyo) injection to avert attacks of <a href=\"https:\/\/www.delveinsight.com\/report-store\/hereditary-angioedema-epidemiology-forecast\">hereditary angioedema<\/a> (HAE) in people 12 years of age and older. It had an Orphan Drug status and Breakthrough Therapy designation. HAE disease is a rare, genetic disease that causes recurring cases of swelling (edema) in different parts of the body. It affects about 1 in 50,000 people. It is potentially life-threatening as well. Takhzyro is a monoclonal antibody that targets inhibition of plasma kallikrein.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Merck_receives_Food_and_Drug_Administration_approval_for_its_two_new_drugs\"><\/span><strong>Merck receives Food and Drug Administration approval for its two new drugs<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Merck, the drug maker bagged Food and Drug Administration approvals for a new non-nucleoside reverse transcriptase inhibitor called doravirine, both alone and in a combo with other HIV therapies. Delstrigo and Pifeltro of the drug maker for treating adult patients with HIV-1, who haven\u2019t had prior antiretroviral treatments, scored Food and Drug Administration acceptance. Delstrigo, a combo of doravirine plus older HIV drugs from Glaxo\u2019s ViiV Healthcare and Gilead, has a warning sign apprising about risks of exacerbating hepatitis B infections.\u00a0Pifeltro contains only doravine, and is to be administered with other antiretroviral drugs.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Food_and_Drug_Administration_commences_pilot_to_aid_sponsors_use_novel_trial_designs\"><\/span><strong>Food and Drug Administration commences pilot to aid sponsors use novel trial designs<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">The Food and Drug Administration has commenced a\u00a0pilot program\u00a0to aid drug developers use intricate innovative trial designs (CID). Sponsors are slated to meet twice with the Food and Drug Administration for discussing regulatory approaches to CID.\u00a0 Food and Drug Administration Officials will lend a helping hand to developers for progressing the use of complex adaptive, Bayesian and otherwise novel clinical trial designs as a part of the latest PDUFA deal. The pilot program is purportedly made for ensuring sponsors to access the input.<\/p>\n<p style=\"text-align: justify;\"><strong>\u00a0<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Food and Drug Administration repudiates ADHD drug by Sunovion Sunovion\u2019s ADHD drug for the treatment of attention-deficit hyperactivity disorder (ADHD) has not been accepted by the Food and Drug Administration, FDA. It is so because the drug for ADHD treatment in its current form needs additional clinical trials and data for accessing the efficacy and [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3148,"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":[1741,1743,704,1742,1744,1133,593],"industry":[17225],"therapeutic_areas":[17229,17240,17238],"class_list":["post-3143","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-adhd-drug","tag-delstrigo","tag-fda","tag-opamine-and-norepinephrine-reuptake-inhibitor","tag-pifeltro","tag-u-s-fda","tag-us-food-and-drug-administration-fda","industry-pharmaceutical","therapeutic_areas-central-nervous-system","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-genetic-disorders"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - 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