{"id":9388,"date":"2020-05-19T17:59:59","date_gmt":"2020-05-19T12:29:59","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=9388"},"modified":"2023-02-10T12:16:30","modified_gmt":"2023-02-10T06:46:30","slug":"recent-pharma-happenings-for-moderna-quidel-neurotrope-clovis","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-moderna-quidel-neurotrope-clovis","title":{"rendered":"Moderna&#8217;s COVID-19 Vaccine; Quidel&#8217;s Lyra gets EUA from FDA; Neurotrope and Metuchen Pharma Announced Merger Agreement; FDA Approval to Rucaparib;"},"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-6a01b8ace1cd3\" 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-6a01b8ace1cd3\"  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\/recent-pharma-happenings-for-moderna-quidel-neurotrope-clovis\/#Moderna_Therapeutics_has_announced_the_positive_results_of_trials_of_its_COVID-19_vaccine_mRNA-1273\" >Moderna Therapeutics has announced the positive results of trials of its COVID-19 vaccine, mRNA-1273.&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\/recent-pharma-happenings-for-moderna-quidel-neurotrope-clovis\/#The_US_FDA_has_recommended_the_use_of_Quidel_Corporations_diagnostic_system_%E2%80%93_Lyra_Direct_SARS-CoV-2_Assay\" >The US FDA has recommended the use of Quidel Corporation\u2019s diagnostic system &#8211; Lyra Direct SARS-CoV-2 Assay.&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\/recent-pharma-happenings-for-moderna-quidel-neurotrope-clovis\/#Neurotrope_and_Metuchen_Pharmaceuticals_have_announced_a_merger_to_form_an_all-stock_deal_to_form_Petros_Pharmaceuticals\" >Neurotrope and Metuchen Pharmaceuticals have announced a merger to form an all-stock deal to form Petros Pharmaceuticals.&nbsp;<\/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\/recent-pharma-happenings-for-moderna-quidel-neurotrope-clovis\/#Clovis_Oncology_has_announced_the_US_FDA_approval_for_its_PARP_inhibitor_Rubraca_rucaparib_for_a_type_of_prostate_cancer\" >Clovis Oncology has announced the US FDA approval for its PARP inhibitor, Rubraca (rucaparib) for a type of prostate cancer.&nbsp;<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-moderna-therapeutics-has-announced-the-positive-results-of-trials-of-its-covid-19-vaccine-mrna-1273\"><span class=\"ez-toc-section\" id=\"Moderna_Therapeutics_has_announced_the_positive_results_of_trials_of_its_COVID-19_vaccine_mRNA-1273\"><\/span><strong>Moderna Therapeutics has announced the positive results of trials of its COVID-19 vaccine, mRNA-1273.&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>&nbsp;The results of interim <strong>Phase I clinical trial<\/strong> showed promising outcomes in terms of efficacy and tolerability and potential of mRNA-1273 against <a href=\"https:\/\/www.delveinsight.com\/report-store\/covid-19-novel-coronavirus-19-therapeutic-pipeline-vaccines-diagnostics-competitive-landscape\">COVID-19<\/a>. The company received the funds for conducting trials from Biomedical Advanced Research and Development Authority (BARDA) and is developing the vaccine along with the U.S. National Institute of Allergy and Infectious Diseases (NIAID).&nbsp;<\/p>\n\n\n\n<p>The trials tested the ability of the vaccine to trigger immune responses against the <a href=\"https:\/\/www.delveinsight.com\/report-store\/covid-19-coronavirus-pipeline-insights\">coronavirus \u2013 SARS-CoV-2<\/a>. Data for doses 25 ug and 100 ug in which the immunogenicity was tested on Day 43 and in case of 250 ug it was tested on Day 29, and all the patients in trials tested confirmed for the antibodies against <a href=\"https:\/\/www.delveinsight.com\/blog\/coronavirus\">SARS-CoV-2<\/a> in their blood samples. The vaccine, when tested in mice, successfully prevent the replication of viral particles.&nbsp;<\/p>\n\n\n\n<p>The company now plans to modify the PHASE II clinical trial to evaluate two dose levels \u2013 50ug, and 100 ug, and for Phase III trial, expected to be launched in July, company plans to dosage to be between 25 ug and 100 ug.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-the-us-fda-has-recommended-the-use-of-quidel-corporation-s-diagnostic-system-lyra-direct-sars-cov-2-assay\"><span class=\"ez-toc-section\" id=\"The_US_FDA_has_recommended_the_use_of_Quidel_Corporations_diagnostic_system_%E2%80%93_Lyra_Direct_SARS-CoV-2_Assay\"><\/span><strong>The US FDA has recommended the use of Quidel Corporation\u2019s diagnostic system &#8211; Lyra Direct SARS-CoV-2 Assay.&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Lyra <a href=\"https:\/\/www.delveinsight.com\/report-store\/covid-19-novel-coronavirus-19-therapeutic-pipeline-vaccines-diagnostics-competitive-landscape\">SARS-CoV-2<\/a> Assay is a real-time RT-PCR assay, designed to identify human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal (N.P.) or oropharyngeal (O.P.) swab specimens from patients with signs and symptoms of <a href=\"https:\/\/www.delveinsight.com\/blog\/questions-and-answers-on-coronavirus-covid-19\">COVID-19<\/a>.<\/p>\n\n\n\n<p>Quidel\u2019s Lyra Direct <a href=\"https:\/\/www.delveinsight.com\/blog\/coronavirus-2019-ncov-is-now-covid-19\">SARS-CoV-2<\/a> Assay now is allowed for direct sample processing as it no longer requires up-front sample extraction. The assay uses a reformulated buffer that makes the detection of the viral RNA easier with a simple 10-minute heat step.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-neurotrope-and-metuchen-pharmaceuticals-have-announced-a-merger-to-form-an-all-stock-deal-to-form-petros-pharmaceuticals\"><span class=\"ez-toc-section\" id=\"Neurotrope_and_Metuchen_Pharmaceuticals_have_announced_a_merger_to_form_an_all-stock_deal_to_form_Petros_Pharmaceuticals\"><\/span><strong>Neurotrope and Metuchen Pharmaceuticals have announced a merger to form an all-stock deal to form Petros Pharmaceuticals.&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The newly formed Petros Pharmaceuticals will focus on men\u2019s health conditions with Metuchen\u2019s <a href=\"https:\/\/www.delveinsight.com\/report-store\/erectile-dysfunction-market\">erectile dysfunction<\/a>. The company has the drug Stendra as its lead product in its armamentarium.<\/p>\n\n\n\n<p>Petros is fuelled by funding worth USD 20 Million from Neurotrope\u2019s along with the revenue generated by the sales of Stendra, initially launched by Auxilium Pharmaceuticals. Last year, the drug managed to generate USD 30 Million.&nbsp;<\/p>\n\n\n\n<p>Other products in the Petros\u2019s pipeline will comprise in-licensed drug H-100 recently for Peyronie\u2019s disease (P.D.) by Metuchen. It will also be tested for indications such as endothelial dysfunction, <a href=\"https:\/\/www.delveinsight.com\/report-store\/prostate-cancer-market\">prostate cancer<\/a>, psychosexual and psychosocial ailments, hormone health and substance use disorders.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clovis-oncology-has-announced-the-us-fda-approval-for-its-parp-inhibitor-rubraca-rucaparib-for-a-type-of-prostate-cancer\"><span class=\"ez-toc-section\" id=\"Clovis_Oncology_has_announced_the_US_FDA_approval_for_its_PARP_inhibitor_Rubraca_rucaparib_for_a_type_of_prostate_cancer\"><\/span><strong>Clovis Oncology<\/strong> <strong>has announced the US FDA approval for its PARP inhibitor, Rubraca (rucaparib) for a type of prostate cancer.<\/strong>&nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Rubraca is an inhibitor of poly ADP ribose polymerase, which is an enzyme commonly found in most cancerous cells. The drug is designed to inactivate the DNA repair pathway in cancerous cells, making it difficult for them to survive. With the approval from the FDA, the drug has become the first PARP-inhibitor in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/prostate-cancer-epidemiology-forecast\">Prostrate Cancer Market<\/a>.&nbsp;<\/p>\n\n\n\n<p>The decision to grant accelerated approval to Rubraca was based on the results of objective response rate (ORR) and duration of response (DOR) data from the Phase II TRITON2 clinical study and has been approved for the treatment of adult patients with a deleterious BRCA mutation (germline and\/or somatic)-associated metastatic castration-resistant <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-castration-resistant-prostate-cancer-market\">prostate cancer<\/a> (mCRPC) who have been treated with androgen receptor-directed therapy and taxane-based <a href=\"https:\/\/www.delveinsight.com\/report-store\/chemotherapy-induced-anemia-market\">chemotherapy<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Moderna Therapeutics has announced the positive results of trials of its COVID-19 vaccine, mRNA-1273.&nbsp; &nbsp;The results of interim Phase I clinical trial showed promising outcomes in terms of efficacy and tolerability and potential of mRNA-1273 against COVID-19. The company received the funds for conducting trials from Biomedical Advanced Research and Development Authority (BARDA) and is [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":9389,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":2,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[2119,18354,18356,18353,18355,18357,17544],"industry":[17225],"therapeutic_areas":[17231,17557,17243],"class_list":["post-9388","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-clovis-oncology","tag-covid-19-vaccine","tag-metuchen-pharmaceuticals","tag-moderna-therapeutics","tag-neurotrope","tag-prostrate-cancer-market","tag-rubraca","industry-pharmaceutical","therapeutic_areas-infectious-diseases","therapeutic_areas-male-health","therapeutic_areas-respiratory-diseases"],"acf":[],"yoast_head":"<!-- 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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\">Clovis Oncology<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">COVID 19 vaccine<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Metuchen Pharmaceuticals<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Moderna Therapeutics<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Neurotrope<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Prostrate Cancer Market<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Rubraca<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Clovis Oncology<\/span>","<span class=\"advgb-post-tax-term\">COVID 19 vaccine<\/span>","<span class=\"advgb-post-tax-term\">Metuchen Pharmaceuticals<\/span>","<span class=\"advgb-post-tax-term\">Moderna Therapeutics<\/span>","<span class=\"advgb-post-tax-term\">Neurotrope<\/span>","<span class=\"advgb-post-tax-term\">Prostrate Cancer Market<\/span>","<span class=\"advgb-post-tax-term\">Rubraca<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 6 years ago","modified":"Updated 3 years ago"},"absolute_dates":{"created":"Posted on May 19, 2020","modified":"Updated on Feb 10, 2023"},"absolute_dates_time":{"created":"Posted on May 19, 2020 5:59 pm","modified":"Updated on Feb 10, 2023 12:16 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