{"id":12322,"date":"2021-06-01T17:28:00","date_gmt":"2021-06-01T11:58:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=12322"},"modified":"2021-07-24T12:58:25","modified_gmt":"2021-07-24T07:28:25","slug":"pharma-happenings-for-amgen-verrica-nexturn-rosvivo-fennec","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-amgen-verrica-nexturn-rosvivo-fennec","title":{"rendered":"Amgen a leader in Undruggable Lung Cancer;  Verrica&#8217;s Skin Disease Drug Delays; Fennec&#8217;s Faith in its Chemotherapy-Induced Hearing Loss Drug; Nexturn Bio&#8217;s Acquisition of RosVivo"},"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-69f48375b3f64\" 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-69f48375b3f64\"  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\/pharma-happenings-for-amgen-verrica-nexturn-rosvivo-fennec\/#FDA_Validates_Use_of_Amgens_KRAS_Inhibitor_in_Lung_Cancer\" >FDA Validates Use of Amgen\u2019s KRAS Inhibitor in Lung Cancer&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\/pharma-happenings-for-amgen-verrica-nexturn-rosvivo-fennec\/#Verrica_Pharmaceuticals_Skin_Disease_Treatment_Delays_in_Approval\" >Verrica Pharmaceuticals\u2019 Skin Disease Treatment &amp; Delays in Approval&nbsp;<\/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\/pharma-happenings-for-amgen-verrica-nexturn-rosvivo-fennec\/#Fennec_Takes_Another_Shot_at_its_Chemotherapy-Induced_Hearing_Loss_Drug\" >Fennec Takes Another Shot at its Chemotherapy-Induced Hearing Loss Drug<\/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\/pharma-happenings-for-amgen-verrica-nexturn-rosvivo-fennec\/#Nexturn_Bio_Inc_Gets_a_Hold_of_a_50_stake_in_RosVivo_Therapeutics\" >Nexturn Bio Inc. Gets a Hold of a 50% stake in RosVivo Therapeutics<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-validates-use-of-amgen-s-kras-inhibitor-in-lung-cancer\"><span class=\"ez-toc-section\" id=\"FDA_Validates_Use_of_Amgens_KRAS_Inhibitor_in_Lung_Cancer\"><\/span><strong>FDA Validates Use of Amgen\u2019s KRAS Inhibitor in Lung Cancer&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In a pathbreaking move, Amgen has gone ahead to emerge as a trailblazer in the undruggable lung cancer space with the approval of its KRAS inhibitor, Lumakras. For eons, the researchers grappled to come up with an effective and potential drug to target cancers with KRAS mutations. However, Amgen finally managed to put a full stop to the woes.&nbsp;<\/p>\n\n\n\n<p>Lumakras (sotorasib) received approval for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). The recommendations came using the Accelerated Approval pathway based on the results from the largest clinical trial, CodeBreaK 100,&nbsp; conducted to date exclusively for patients with the KRAS G12C mutation.<\/p>\n\n\n\n<p>Each year,&nbsp; over 2 million people report for new lung cancer diagnoses, out of which approximately 84% of the cases report <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-carcinoma-nsclc-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\">NSCLC <\/a>with KRAS G12C as one of the most prevalent driver mutations. To date, the unmet needs in the NSCLC market reportedly remain huge with only a limited number of treatment options; however, with Amgen\u2019s commitment to benefit NSCLC patients, the treatment gap appears to close a bit.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-verrica-pharmaceuticals-skin-disease-treatment-delays-in-approval\"><span class=\"ez-toc-section\" id=\"Verrica_Pharmaceuticals_Skin_Disease_Treatment_Delays_in_Approval\"><\/span><strong>Verrica Pharmaceuticals\u2019 Skin Disease Treatment &amp; Delays in Approval&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Verrica Pharmaceuticals, a West Chester-based dermatology company developing therapeutics to bridge the treatment hollows in the skin disease market, is for long now struggling to assure the US drug regulatory agency of the efficacy and potential of its lead candidate VP-102.&nbsp;<\/p>\n\n\n\n<p>The drug is in the development for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/molluscum-contagiosum-mc-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">molluscum contagiosum,<\/a> or molluscum, a highly contagious and primarily pediatric viral skin disease, and common warts. The company originally submitted the NDA for the drug in September 2019 and the FDA issued a complete response letter (CRL) in July 2020. The company resubmitted the NDA with the requested data, expected a response by June 2021, which is now extended by three months.<\/p>\n\n\n\n<p>At the moment, there is no approved standard of care in the molluscum contagiosum market, suggesting a bright opportunity for the company to grab the share post-approval. The company also plans to proceed with a phase II trial for its another asses VP-103 for the treatment of plantar warts.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fennec-takes-another-shot-at-its-chemotherapy-induced-hearing-loss-drug\"><span class=\"ez-toc-section\" id=\"Fennec_Takes_Another_Shot_at_its_Chemotherapy-Induced_Hearing_Loss_Drug\"><\/span><strong>Fennec Takes Another Shot at its Chemotherapy-Induced Hearing Loss Drug<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Fennec Pharmaceuticals, a speciality pharmaceutical company, is devoting itself to develop and commercialize its drug <strong>PEDMARK <\/strong>for the prevention of platinum-induced ototoxicity in pediatric patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/chemotherapy-induced-hearing-loss-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">chemotherapy-induced hearing loss<\/a>.<\/p>\n\n\n\n<p>The therapy, PEDMARK is a unique formulation of sodium thiosulfate for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to &lt; 18 years of age with localized, non-metastatic, solid tumors.<\/p>\n\n\n\n<p>The company is now resubmitting the NDA to the USFDA after receiving a CRL, which requested more data owing to deficiencies with the facility of the drug product manufacturer; no clinical safety or efficacy issues were identified and there was no requirement for further clinical data.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-nexturn-bio-inc-gets-a-hold-of-a-50-stake-in-rosvivo-therapeutics\"><span class=\"ez-toc-section\" id=\"Nexturn_Bio_Inc_Gets_a_Hold_of_a_50_stake_in_RosVivo_Therapeutics\"><\/span><strong>Nexturn Bio Inc. Gets a Hold of a 50% stake in RosVivo Therapeutics<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Nexturn Bio, a subsidiary of Nexturn Bioscience Co., Ltd., acquired a 50% stake in RosVivo Therapeutics Inc. (&#8220;Rosvivo&#8221;) by shelling out 5.5 million U.S. dollars. The move of Nexturn Bio seems to help bolster its pipeline portfolio with the help of RosVivo\u2019s miRNA technology.<\/p>\n\n\n\n<p>The duo plans to develop drugs to target diabetes, obesity, non-alcoholic fatty liver disease (NAFLD), gastrointestinal (GI) dysmotility, and <a href=\"https:\/\/www.delveinsight.com\/report-store\/covid-19-novel-coronavirus-19-therapeutic-pipeline-vaccines-diagnostics-competitive-landscape?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">COVID-19<\/a>.<\/p>\n\n\n\n<p>RosVivo Therapeutics\u2019 innovative miRNA drug <strong>RSVI-301 <\/strong>signficantly lowers down the&nbsp; injection frequency, prolongs effect, and alleviates side effects in Diabetes, as shown in pre-clinical trials. Once approved, it will earn the tag of the first miRNA-based therapy that targets diabetes and COVID-19.<\/p>\n\n\n\n<p>Thus, the decision of Nexturn backed by several KOLs in endocrinology and gastroenterology is expected to give the company an advantage in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/diabetes-market?utm_source=blog&amp;utm_medium=news&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">Diabetes market<\/a>.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Validates Use of Amgen\u2019s KRAS Inhibitor in Lung Cancer&nbsp; In a pathbreaking move, Amgen has gone ahead to emerge as a trailblazer in the undruggable lung cancer space with the approval of its KRAS inhibitor, Lumakras. For eons, the researchers grappled to come up with an effective and potential drug to target cancers with [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":12328,"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":[160,17025,10830,812,17026,365,17023,17024,1111,540],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-12322","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-chemotherapy","tag-chemotherapy-induced-hearing-loss","tag-covid-19","tag-diabetes","tag-kras-inhibitors","tag-lung-cancer","tag-molluscum","tag-molluscum-contagiosum","tag-nsclc","tag-skin-disorders","industry-pharmaceutical","therapeutic_areas-oncology"],"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>Amgen in NSCLC market; Verrica&#039;s Skin Disease Drug Delays &amp; more<\/title>\n<meta name=\"description\" content=\"Amgen &amp; Undruggable Lung Cancer; Verrica&#039;s Skin Disease Drug Delays; Nexturn Bio&#039;s Acquisition of RosVivo; Fennec&#039;s Faith in its PEDMARK\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-amgen-verrica-nexturn-rosvivo-fennec\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Amgen in NSCLC market; Verrica&#039;s Skin Disease Drug Delays &amp; more\" \/>\n<meta property=\"og:description\" content=\"Amgen &amp; Undruggable Lung Cancer; Verrica&#039;s Skin Disease Drug Delays; 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Joshi","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/sjoshidelveinsight-com"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2021\/06\/01172723\/pharma-news-updates-for-amgen-verrica-nexturn-rosvivo-fennec-300x187.jpg","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - 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\">chemotherapy<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Chemotherapy-Induced Hearing Loss<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">COVID-19<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Diabetes<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">KRAS Inhibitors<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Lung Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Molluscum<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">molluscum contagiosum<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">NSCLC<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Skin disorders<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">chemotherapy<\/span>","<span class=\"advgb-post-tax-term\">Chemotherapy-Induced Hearing Loss<\/span>","<span class=\"advgb-post-tax-term\">COVID-19<\/span>","<span class=\"advgb-post-tax-term\">Diabetes<\/span>","<span class=\"advgb-post-tax-term\">KRAS Inhibitors<\/span>","<span class=\"advgb-post-tax-term\">Lung Cancer<\/span>","<span class=\"advgb-post-tax-term\">Molluscum<\/span>","<span class=\"advgb-post-tax-term\">molluscum contagiosum<\/span>","<span class=\"advgb-post-tax-term\">NSCLC<\/span>","<span class=\"advgb-post-tax-term\">Skin disorders<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 5 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Jun 1, 2021","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Jun 1, 2021 5:28 pm","modified":"Updated on Jul 24, 2021 12:58 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