{"id":1791,"date":"2017-01-17T12:20:46","date_gmt":"2017-01-17T12:20:46","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=1791"},"modified":"2021-07-24T12:56:37","modified_gmt":"2021-07-24T07:26:37","slug":"notizia-22","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-22","title":{"rendered":"FDA accepts; Keytruda takes lead; M Pharmaceutical develops; Merck Deploys Palantir"},"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-69f998903eab8\" 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-69f998903eab8\"  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-22\/#US_FDA_accepts_Mylans_BLA_for_proposed_trastuzumab_product\" >US FDA accepts Mylan\u2019s BLA for proposed trastuzumab product<\/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-22\/#Mercks_Keytruda_takes_combo_lead_with_surprise_FDA_filing\" >Merck&#8217;s Keytruda takes combo lead with surprise FDA filing<\/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-22\/#M_Pharmaceutical_to_develop_new_topical_drug_product_for_FSD\" >M Pharmaceutical to develop new topical drug product for FSD<\/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-22\/#Merck_KGaA_to_Deploy_Palantir_Data_Analytics\" >Merck KGaA to Deploy Palantir Data Analytics<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"US_FDA_accepts_Mylans_BLA_for_proposed_trastuzumab_product\"><\/span>US FDA accepts Mylan\u2019s BLA for proposed trastuzumab product<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Biocon and Mylan have announced acceptance of the latter\u2019s biologics licence application (BLA) by the US Food and Drug Administration (FDA) for MYL-1401O, a proposed biosimilar trastuzumab. Mylan\u2019s MYL-1401O is indicated to treat certain HER2-positive breast cancers.Nearly two million women across the globe are diagnosed with breast cancer every year. Mylan has exclusive commercialisation rights for this product in the US, Canada, Japan, Australia, New Zealand and the European Union and European Free Trade Association countries. Biocon has co-exclusive rights with Mylan in the remaining parts of the world.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Mercks_Keytruda_takes_combo_lead_with_surprise_FDA_filing\"><\/span>Merck&#8217;s Keytruda takes combo lead with surprise FDA filing<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Merck &amp; Co.\u2019s immunotherapy drug Keytruda is yet another step closer to eclipsing its competitors in lung cancer. In an out-of-the-blue announcement, the U.S.-based drugmaker said the FDA had accepted its application for a new Keytruda-plus-chemotherapy combo use that could expand its market considerably, and was granted priority review to boot. Merck had previously unveiled some impressive study data on the chemo combo approach, and Merck\u2019s application is based on data from the Keynote-021 trial, and, if approved, would be Keytruda\u2019s first in combination with another drug.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"M_Pharmaceutical_to_develop_new_topical_drug_product_for_FSD\"><\/span>M Pharmaceutical to develop new topical drug product for FSD<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Canadian-headquartered M Pharmaceutical has announced its plan to continue advancing the development of a topical drug product as part of its planned acquisition of 40 J&#8217;s. The drug will be used for the treatment of female sexual dysfunction (FSD). According to the company\u2019s CEO, this topical drug product would focus on women with orgasm and arousal difficulties. The company\u2019s proposed treatment is topical, local and non-systemic, while being non-hormonal and is not a central nervous system drug.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Merck_KGaA_to_Deploy_Palantir_Data_Analytics\"><\/span>Merck KGaA to Deploy Palantir Data Analytics<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Merck KGaA has partnered with Palantir Technologies, a developer of data integration and analysis software, headquartered in Palo Alto, CA. The partnership will leverage Palantir&#8217;s data analytics capabilities to help Merck KGaA rapidly develop and commercialize new products and improve patient outcomes.\u00a0\u00a0 Initially, Merck KGaA will apply the technology to cancer treatment and patient services and then across all three of its business sectors: Healthcare, Life Science and Performance Materials. The partnership aims to increase precision of the drug development process by developing a collaborative data and analytics platform so that researchers can analyze real-world and bioinformatics data to understand the patients who may benefit most.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>US FDA accepts Mylan\u2019s BLA for proposed trastuzumab product Biocon and Mylan have announced acceptance of the latter\u2019s biologics licence application (BLA) by the US Food and Drug Administration (FDA) for MYL-1401O, a proposed biosimilar trastuzumab. Mylan\u2019s MYL-1401O is indicated to treat certain HER2-positive breast cancers.Nearly two million women across the globe are diagnosed with [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1712,"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":[420,712,747],"industry":[17225],"therapeutic_areas":[17228,17411],"class_list":["post-1791","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-news","tag-pharma-industry","tag-research-and-deveopment","industry-pharmaceutical","therapeutic_areas-oncology","therapeutic_areas-womens-health"],"acf":[],"yoast_head":"<!-- This site is optimized 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