{"id":3395,"date":"2018-10-11T15:05:09","date_gmt":"2018-10-11T09:35:09","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=3395"},"modified":"2021-07-24T12:57:05","modified_gmt":"2021-07-24T07:27:05","slug":"commercial-and-others","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/commercial-and-others","title":{"rendered":"COMMERCIAL AND OTHERS"},"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-6a2d38081377a\" 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-6a2d38081377a\"  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\/commercial-and-others\/#Cytosen_Therapeutics_and_KBI_Biopharma_pair_up_to_manufacture_NK_cells_and_Nanoparticles\" >Cytosen Therapeutics and KBI Biopharma pair up to manufacture NK cells and Nanoparticles&nbsp;<\/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\/commercial-and-others\/#Others\" >Others<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/commercial-and-others\/#New-generation_drugs_undergo_testing_to_treat_people_with_Alzheimers\" >New-generation drugs undergo testing to treat people with Alzheimer\u2019s<\/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\/commercial-and-others\/#Valsartan_manufacturing_process_issues_drew_imports_from_Chinese_Drugmaker_to_standstill\" >Valsartan manufacturing process issues drew imports from Chinese Drugmaker to standstill<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Cytosen_Therapeutics_and_KBI_Biopharma_pair_up_to_manufacture_NK_cells_and_Nanoparticles\"><\/span><strong><em>Cytosen Therapeutics and KBI Biopharma pair up to manufacture NK cells and Nanoparticles&nbsp;<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n<p> CytoSen Therapeutics and KBI Biopharma paired up to manufacture therapeutic Natural Killer Cell by using a closed system manufacturing process. According to the initial collaboration, KBI will be subjected to manufacture the NK cell product for Cytosen\u2019s upcoming Phase II trial evaluating company\u2019s CSTD002-NK in acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients undergoing haploidentical hematopoietic stem cell transplantation (HSCT), expected to begin the first half of 2019. KBI will also manufacture CytoSen\u2019s proprietary nanoparticles used in the expansion of the NK cell product. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Others\"><\/span>Others<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"New-generation_drugs_undergo_testing_to_treat_people_with_Alzheimers\"><\/span><strong><em>New-generation drugs undergo testing to treat people with Alzheimer\u2019s<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>Cognition Health has come up with a Generation Study that is recruiting thousands of people at risk of the condition for preventive treatment of Alzheimer\u2019s in the Europe, United States, and Canada. The people at risk of developing the neurodegenerative disorder will have access to a new-generation drug to stop the disease from erupting in the first place.<\/p>\n\n\n\n<p>In the first phase of the trial, healthy volunteers with no sign of cognitive decline and aged 60-75 will be recruited and have a cheek swab taken in order to check if they carry any genetic markers that put them at risk of Alzheimer\u2019s. The design of the trial will further include those with two copies if the APOE4 gene associated with Alzheimer\u2019s and those with one copy of the gene. The recruited participants will be eligible for the treatment and follow ups for five to eight years.<\/p>\n\n\n\n<p>The new drug therapy is designed to target abnormalities in certain brain proteins. The scientists have identified that beta-amyloid is overproduced by patients with Alzheimer\u2019s. This is due to the over-activity of the BACE enzyme. As stated by the company, the upcoming product has been proven effective and is designed to reduce the activity of BACE enzyme and to further reduce the accumulation of the toxic protein in the brain.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Valsartan_manufacturing_process_issues_drew_imports_from_Chinese_Drugmaker_to_standstill\"><\/span><strong><em>Valsartan manufacturing process issues drew imports from Chinese Drugmaker to standstill<\/em><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>On September 30, 2018, the FDA halted imports of drug ingredients manufactured by China\u2019s Zhejiang Huahai Pharmaceuticals after the presence of N-nitrosodimethylamine (NDMA) was found in one of its manufactured products, Valsartan. The company has sold USD 50 million worth of valsartan in 2017 and the latest update can prove to be a huge loss for the company as a significant number of valsartan products have been recalled across the globe due to the impurity. <br>The halt was led by major manufacturing process issues observed during an inspection of the company\u2019s manufacturing plant. The inspector pointed out a range of serious problems regarding Huahai\u2019s quality management system in FDA\u2019s heavily-redacted inspection report. The inspection report further stated that the Chinese firm did not carry out a risk assessment for a change in their drug-making process. <br>This update raises the question of whether other products manufactured in China is as per the global standards.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cytosen Therapeutics and KBI Biopharma pair up to manufacture NK cells and Nanoparticles&nbsp; CytoSen Therapeutics and KBI Biopharma paired up to manufacture therapeutic Natural Killer Cell by using a closed system manufacturing process. According to the initial collaboration, KBI will be subjected to manufacture the NK cell product for Cytosen\u2019s upcoming Phase II trial evaluating [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3389,"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":[72,3381,704,17680,17681],"industry":[17225],"therapeutic_areas":[17233,17245,17234],"class_list":["post-3395","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-alzheimers-disease","tag-cytosen-therapeutics","tag-fda","tag-kbi-biopharma","tag-valsartan","industry-pharmaceutical","therapeutic_areas-hematological-disorders","therapeutic_areas-neurology","therapeutic_areas-rare-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - 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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\">Alzheimer\u2019s disease<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Cytosen Therapeutics<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">FDA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">KBI Biopharma<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Valsartan<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Alzheimer\u2019s disease<\/span>","<span class=\"advgb-post-tax-term\">Cytosen Therapeutics<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">KBI Biopharma<\/span>","<span class=\"advgb-post-tax-term\">Valsartan<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 8 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Oct 11, 2018","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Oct 11, 2018 3:05 pm","modified":"Updated on Jul 24, 2021 12:57 pm"},"featured_img_caption":"","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/3395","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=3395"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/3395\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/3389"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=3395"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=3395"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=3395"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=3395"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=3395"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}