[{"orgOrder":0,"company":"Berlin Chemie","sponsor":"Helsinn Group","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Helsinn Group Grants Exclusive Licensing Rights to Berlin-Chemie AG, a company of the Menarini Group, for ONICIT\u00ae\/ALOXI\u00ae and AKYNZEO\u00ae in Russia and CIS region","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"},{"orgOrder":0,"company":"Taiho Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Taiho Submits NDA for NK1 Receptor Antagonist Fosnetupitant for Prevention of Gastrointestinal Symptoms Associated with Cancer Chemotherapy","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"},{"orgOrder":0,"company":"Taiho Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Taiho Pharmaceutical Obtains Approval to Manufacture and Market NK1 Receptor Antagonist Arokaris\u00ae I.V. Infusion 235mg in Japan","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"}]
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The approval is based on results of a Phase III clinical study (CONSOLE6) comparing the efficacy and safety of Arokaris® versus fosaprepitant in patients receiving highly emetogenic chemotherapy in combination with palonosetron and dexamethasone.
Taiho Pharmaceutical has submitted to the Japanese Ministry of Health, Labour and Welfare a new drug application for an NK1 receptor antagonist antiemetic drug for gastrointestinal symptoms (nausea and vomiting) associated with cancer chemotherapy.
Berlin-Chemie AG has been granted exclusive rights to import, distribute, promote, market and sell AKYNZEO® and ONICIT® in Russia and CIS region to manage chemotherapy-induced nausea and vomiting.