{"id":1880,"date":"2017-02-14T12:16:24","date_gmt":"2017-02-14T12:16:24","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=1880"},"modified":"2021-07-24T12:56:40","modified_gmt":"2021-07-24T07:26:40","slug":"notizia-26","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-26","title":{"rendered":"SEC scrutinizes; Acacia meets endpoint; Axovant&#8217;s dementia drug; Novartis expands; Aurobindo responds"},"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-6a05e3ef961e0\" 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-6a05e3ef961e0\"  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-26\/#In_letter_to_Allergan_SEC_says_it_will_scrutinize_industrys_use_of_non-GAAP_accounting\" >In letter to Allergan, SEC says it will scrutinize industry&#8217;s use of non-GAAP accounting<\/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-26\/#Phase_3_test_is_on_the_way_for_Axovants_dementia_drug\" >Phase 3 test is on the way for Axovant&#8217;s dementia drug<\/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-26\/#Novartis_expands_Vivinda_TV_offering_docs_digital_access_to_medical_conferences\" >Novartis expands Vivinda TV, offering docs digital access to medical conferences<\/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-26\/#Aurobindo_responds_to_White_House_urging_plans_second_US_plant\" >Aurobindo responds to White House urging, plans second U.S. plant<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"In_letter_to_Allergan_SEC_says_it_will_scrutinize_industrys_use_of_non-GAAP_accounting\"><\/span>In letter to Allergan, SEC says it will scrutinize industry&#8217;s use of non-GAAP accounting<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>When the SEC criticized Valeant Pharmaceuticals over its use of non-GAAP reporting, it seemed like a regulator barking at a company known for pushing the limits. But now the agency has fired a warning shot across the bow of the industry, saying in a letter to Allergan that it intends to examine how the industry is potentially exploiting the practice. In its Jan. 11 letter to Allergan CFO, the SEC admonished the company for using non-GAAP in reporting its earnings per share. While other companies may do the same thing, and the agency said it didn\u2019t agree with its use that way.<\/p>\n<p><strong>Acacia Pharma&#8217;s Baremsis meets primary endpoint in pivotal phase 3 study<\/strong><\/p>\n<p>Acacia Pharma Group Ltd., the supportive care company developing products for US and international markets, has announced positive results from its fourth and final pivotal phase 3 study investigating Baremsis (amisulpride injection, formerly APD421) for the rescue treatment of patients who develop post-operative nausea &amp; vomiting (PONV), despite having received prior antiemetic prophylaxis.\u00a0 Acacia Pharma has now completed four pivotal phase 3 studies of Baremsis successfully, all meeting their primary endpoint, and these will form the basis of the efficacy and safety package which the Company aims to submit to the US FDA as part of its New Drug Application (NDA) in 1H 2017.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Phase_3_test_is_on_the_way_for_Axovants_dementia_drug\"><\/span>Phase 3 test is on the way for Axovant&#8217;s dementia drug<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Positive results in a first crop of patients treated with its dementia drug have encouraged Axovant to start preparing for a phase 3 study. So far 11 patients with Lewy body dementia (LBD) have been treated with nelotanserin, which is being developed to tackle the visual hallucinations and sleep disturbances that can afflict people with these diseases. The results have outpaced expectations, with nelotanserin achieving a significant improvement in extrapyramidal symptoms\u2014Parkinson&#8217;s disease-like effects caused by the nerve degeneration in LBD\u2014as measured by the Unified Parkinson&#8217;s Disease Rating Scale (UPDRS). Final data are due mid-year, with the phase 3 trial due to start in the second half of the year.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Novartis_expands_Vivinda_TV_offering_docs_digital_access_to_medical_conferences\"><\/span>Novartis expands Vivinda TV, offering docs digital access to medical conferences<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Vivinda TV, a burgeoning virtual conference platform created to deliver on-demand medical content, most recently aired the full unedited content from the European Cancer Congress held in Amsterdam last month. And the platform has worked so well that Novartis is ramping it up. In June, for the American Society of Clinical Oncology conference, Vivinda TV drew 4,600 registrations from virtual delegates in 103 countries, and for the European School for Advanced Studies in Ophthalmology conference, Vivinda TV drew 1,800 virtual delegates\u2014compared with the 500 to 600 that attend in person. Currently, the platform can be accessed by healthcare providers in any country except Canada, Japan, Norway, Sweden and the U.S.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Aurobindo_responds_to_White_House_urging_plans_second_US_plant\"><\/span>Aurobindo responds to White House urging, plans second U.S. plant<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Aurobindo Pharma, which just started on its first U.S. plant in August, said today it will build a second sterile injectables plant at its site in New Jersey. Hyderabad-based Aurobindo, which derives about half of its finished drug sales from the U.S., still produces most of those in India, where it has half a dozen plants. Today, the company reported third-quarter earnings of 3.9 billion INR ($58.4 million), up 11.5%. It said that U.S. sales of both oral and injected drugs were up 12% for the quarter but that pricing pressure on generic meds in the U.S. had dampened its earnings.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In letter to Allergan, SEC says it will scrutinize industry&#8217;s use of non-GAAP accounting When the SEC criticized Valeant Pharmaceuticals over its use of non-GAAP reporting, it seemed like a regulator barking at a company known for pushing the limits. But now the agency has fired a warning shot across the bow of the industry, [&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":[70,2296,134,204,730,423],"industry":[17225],"therapeutic_areas":[17229,17245,17228],"class_list":["post-1880","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-allergan","tag-axovant","tag-business-consultant","tag-delveinsight","tag-notizia","tag-novartis","industry-pharmaceutical","therapeutic_areas-central-nervous-system","therapeutic_areas-neurology","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast 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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\">Axovant<\/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\">DelveInsight<\/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\">Novartis<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Allergan<\/span>","<span class=\"advgb-post-tax-term\">Axovant<\/span>","<span class=\"advgb-post-tax-term\">Business Consultant<\/span>","<span class=\"advgb-post-tax-term\">DelveInsight<\/span>","<span class=\"advgb-post-tax-term\">Notizia<\/span>","<span class=\"advgb-post-tax-term\">Novartis<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Feb 14, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Feb 14, 2017 12:16 pm","modified":"Updated on Jul 24, 2021 12:56 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