{"id":1519,"date":"2016-11-08T12:07:03","date_gmt":"2016-11-08T12:07:03","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=1519"},"modified":"2021-07-24T12:56:34","modified_gmt":"2021-07-24T07:26:34","slug":"notizia-13","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-13","title":{"rendered":"Fresenius Kabi introduced Bivalirudin; Envigo Launches; Mylan&#8217;s MAA accepted; Pricing hit pharma"},"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-6a01b8d46da42\" 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-6a01b8d46da42\"  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-13\/#Fresenius_Kabi_introduced_Bivalirudin_for_Injection\" >Fresenius Kabi introduced Bivalirudin for Injection<\/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-13\/#Envigo_Launches_Hepatotoxicity_Testing\" >Envigo Launches Hepatotoxicity Testing<\/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-13\/#Mylans_MAA_accepted_by_EMA_for_insulin_glargine\" >Mylan&#8217;s MAA accepted by EMA for insulin glargine.<\/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-13\/#Pricing_pressure_may_hit_Indian_pharma\" >Pricing pressure may hit Indian pharma<\/a><\/li><\/ul><\/nav><\/div>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Fresenius_Kabi_introduced_Bivalirudin_for_Injection\"><\/span>Fresenius Kabi introduced Bivalirudin for Injection<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Fresenius Kabi announced that it has introduced Bivalirudin for Injection in the United States, which is an anticoagulant, and a generic alternative to Angiomax. Fresenius Kabi\u2019s Bivalirudin was approved by the U.S. Food and Drug Administration in October. The U.S. market for Bivalirudin for Injection is approximately $240 million. Fresenius Kabi\u2019s Bivalirudin for Injection is available in single-dose vials, each containing 250 mg of Bivalirudin.<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Envigo_Launches_Hepatotoxicity_Testing\"><\/span>Envigo Launches Hepatotoxicity Testing<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Envigo has launched a program of in vitro technologies aimed at helping to predict the likelihood of compounds causing Drug Induced Livery Injury (DILI) \u2013 one of the major causes of drugs being withdrawn from the market. The new DILI Assessment program can help identify whether a drug exhibits possible risk factors associated with hepatotoxicity. The program can be run in full, using all of its tests, or can be conducted using single assays as required.<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Mylans_MAA_accepted_by_EMA_for_insulin_glargine\"><\/span>Mylan&#8217;s MAA accepted by EMA for insulin glargine.<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">European Medicines Agency (EMA) has accepted review of Mylan&#8217;s Marketing Authorisation Application (MAA) for insulin glargine, a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children aged six and older) with type 1 diabetes for the control of high blood sugar. Mylan and Biocon have co-developed insulin glargine. The firms plan to offer another insulin treatment option for diabetic patients, who often face significant expense to manage their disease.<\/p>\n<h2 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Pricing_pressure_may_hit_Indian_pharma\"><\/span>Pricing pressure may hit Indian pharma<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Indian pharma companies like Sun Pharma, Dr Reddy&#8217;s, Lupin and Zydus may face erosion in margins and a slower growth over the next few months due to pricing pressure and an uncertain regulatory environment in the US. This comes even as some generic companies are already facing trouble on account of an anti-trust investigation by the US Department of Justice (DoJ) over generic drug pricing. Certain companies have already been facing the heat over the last few weeks, while global and Indian generics&#8217; stocks went for a free fall on November 4 following news that the DoJ investigation is likely to result in charges being filed before the year-end.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Fresenius Kabi introduced Bivalirudin for Injection Fresenius Kabi announced that it has introduced Bivalirudin for Injection in the United States, which is an anticoagulant, and a generic alternative to Angiomax. Fresenius Kabi\u2019s Bivalirudin was approved by the U.S. Food and Drug Administration in October. The U.S. market for Bivalirudin for Injection is approximately $240 million. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1520,"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":[204,641,642,640,412,639],"industry":[17225],"therapeutic_areas":[17240,17239,17278],"class_list":["post-1519","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-delveinsight","tag-envigo","tag-fresenius-kabi","tag-indian-pharma","tag-mylan","tag-pharma-news","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-gastroenterology","therapeutic_areas-other-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO 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