{"id":6082,"date":"2019-09-26T13:56:52","date_gmt":"2019-09-26T08:26:52","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=6082"},"modified":"2022-08-16T10:03:21","modified_gmt":"2022-08-16T04:33:21","slug":"pharma-happenings-for-evotec-takeda-bavarian-nordic","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-evotec-takeda-bavarian-nordic","title":{"rendered":"EU\u2019s labels Nirogacestat an Orphan drug; FDA Approves First Smallpox, Monkeypox Vaccine; Evotec and Takeda collaborates to discover clinical candidates"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-european-commission-grants-orphan-drug-designation-for-nirogacestat-for-the-treatment-of-soft-tissue-sarcoma\"><strong>European Commission Grants Orphan Drug Designation for Nirogacestat for\nthe Treatment of Soft Tissue Sarcoma. <\/strong><\/h2>\n\n\n\n<p>Nirogacestat is a selective oral small molecule, gamma-secretase inhibitor under development by SpringWork Therapeutics. Currently, in Phase III development, the drug is investigated for the treatment of progressive Desmoid tumors, which are a type of soft-tissue tumour. <\/p>\n\n\n\n<p>The drug has already been recommended\nby the FDA in June 2018. <\/p>\n\n\n\n<p>Desmoid tumors are an abnormal\nincrease in the connective tissues. The connective tissues are responsible for\nthe strength and flexibility of the bones, ligaments, and muscles. These tumors\nare considered locally invasive but non-metastasizing.<\/p>\n\n\n\n<p>Desmoid Tumors account for less than\n3% of soft tissue tumors. According to orpha.net, the annual Desmoid tumors incidence\nis estimated to range between 1\/250,000-1\/500,000. These tumors more\npredominantly affect women between the ages of 15-60 years. <\/p>\n\n\n\n<p>Soft Tissue Sarcomas (STS) is a family\nof rare, mesenchymal (connective tissue) neoplasms with heterogeneous differentiation\nand may arise in various organs (including fat, muscle, nerve and nerve sheath,\nblood vessels, and other connective tissue).<\/p>\n\n\n\n<p>As per the American Cancer Society&#8217;s\nestimates, a slight male preponderance is observed over the female, although this\ndifference is rarely statistically significant.<\/p>\n\n\n\n<p>These tumors develop mainly in adults\naround the age of 50, the frequency increases with age; and 10% of patients are\nchildren and adolescents.<\/p>\n\n\n\n<p>The market outlook and treatment landscape of STS have changed dramatically in the last decades, with advances in the diagnosis of subtyping and with the introduction of targeted therapies. The treatment market is segmented into surgery, radiation therapy, chemotherapy, anti-angiogenesis drugs and targeted therapy.<\/p>\n\n\n\n<p>Sarcoma treatment landscape has changed dramatically in the last few years with the introduction of targeted therapies.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Evotec-\nGermany based pharma company has entered into a collaboration with Japan\u2019s\nTakeda Pharmaceutical for the development of at least five drug discovery\nprograms across a broad range of indications.<\/strong><\/h2>\n\n\n\n<p>Under the terms of the agreement, Evotec will use its integrated drug discovery program to advance Takeda\u2019s therapeutic areas namely oncology, gastroenterology, neuroscience and rare diseases.<\/p>\n\n\n\n<p>Evotec is planning to use the drug\ndiscovery platform to accelerate small molecule programs. Once Evotec is able\nto produce a drug candidate, Takeda will have the option to fully acquire it. <\/p>\n\n\n\n<p>Furthermore, Takeda will pay Evotec the amount upfront one-time to gain access to the latter\u2019s platform. Whereas, Evotec is eligible to gain an amount of USD 170 million for achieving each milestone in addition to realities on the sales. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>The US FDA has given its recommendation for Jynneos Smallpox and Monkeypox Vaccine, to be used for the prevention of monkeypox and smallpox in adults aged 18 years and above<\/strong>. <\/h2>\n\n\n\n<p>Manufactured by <strong>Bavarian Nordic<\/strong>, this is the only present vaccine which is <a href=\"https:\/\/www.delveinsight.com\/blog\/gazyva-for-lupus-nephritis\">FDA-approved<\/a> for the prevention of monkeypox and smallpox. <\/p>\n\n\n\n<p>Smallpox is a viral infection caused by Variola <a href=\"https:\/\/www.delveinsight.com\/blog\/surge-in-hiv-drug-resistance\">virus <\/a>with fatality rates approximately 30% overall, although survivors frequently suffered significant morbidity including blindness and skin scarring, as per NCBI. <\/p>\n\n\n\n<p>Smallpox\nis in existence for over 3,000 years and was considered the global threat until\nit was eradicated by a collective global vaccination programme led by the World\nHealth Organization. <\/p>\n\n\n\n<p>However, it still remains the most feared disease due to the nature of a highly contagious virus. <\/p>\n\n\n\n<p>The\nmonkeypox virus is similar to human smallpox, however, monkeypox virus is much trivial\nthan smallpox, but it can be fatal.<\/p>\n\n\n\n<p>The\nvaccine will be administered to people who are at high risk of either of the\ndiseases. <\/p>\n\n\n\n<p>Jynneos\nvaccine is a part of the Strategic National Stockpile (SNS), which will ensure\nit easy and convenient accessibility to the masses in the US. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>European Commission Grants Orphan Drug Designation for Nirogacestat for the Treatment of Soft Tissue Sarcoma. Nirogacestat is a selective oral small molecule, gamma-secretase inhibitor under development by SpringWork Therapeutics. Currently, in Phase III development, the drug is investigated for the treatment of progressive Desmoid tumors, which are a type of soft-tissue tumour. The drug has [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6084,"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":[349,639,5789],"industry":[17225],"therapeutic_areas":[17231,17234],"class_list":["post-6082","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-latest-pharma-news","tag-pharma-news","tag-recent-pharma-news","industry-pharmaceutical","therapeutic_areas-infectious-diseases","therapeutic_areas-rare-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU\u2019s labels Nirogacestat an Orphan drug; FDA Approves First Smallpox<\/title>\n<meta name=\"description\" content=\"European Commission Grants Orphan Drug Designation for Nirogacestat for the Treatment of Soft Tissue Sarcoma. 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