{"id":11213,"date":"2020-11-17T11:57:57","date_gmt":"2020-11-17T06:27:57","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=11213"},"modified":"2023-02-10T11:47:36","modified_gmt":"2023-02-10T06:17:36","slug":"recent-pharma-happenings-for-albireo-lupin-moderna-gilead-novo","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-albireo-lupin-moderna-gilead-novo","title":{"rendered":"Albireo Pharma&#8217;s PFIC Therapy;  Lupin\u2019s Trichomoniasis Oral Drug; Moderna&#8217;s Weapon Against COVID; Gilead &#038; Novo Nordisk&#8217;s Cocktail Therapy for NASH"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 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-6a68b572705c7\" 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-6a68b572705c7\"  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-albireo-lupin-moderna-gilead-novo\/#Albireo_Pharma_Hopeful_to_Commercialize_its_PFIC_Treatment_by_the_End_of_the_Year\" >Albireo Pharma Hopeful to Commercialize its PFIC Treatment by the End of the Year<\/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-albireo-lupin-moderna-gilead-novo\/#FDA_Accepts_Lupins_Supplemental_New_Drug_Application_Filed_for_Trichomoniasis_Treatment_Solosec\" >FDA Accepts Lupin\u2019s Supplemental New Drug Application Filed for Trichomoniasis Treatment, Solosec&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-albireo-lupin-moderna-gilead-novo\/#Another_Hope_Lights_Up_as_Moderna_Declares_its_COVID-19_Vaccine_is_Over_94_Effective\" >Another Hope Lights Up as Moderna Declares its COVID-19 Vaccine&nbsp; is Over 94% Effective<\/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-albireo-lupin-moderna-gilead-novo\/#Gilead_Novo_Nordisks_Cocktail_Therapy_Starts_on_the_Road_to_be_a_Blockbuster_in_NASH_Market\" >Gilead &amp; Novo Nordisk&#8217;s Cocktail Therapy Starts on the Road to be a Blockbuster in NASH Market&nbsp;<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Albireo_Pharma_Hopeful_to_Commercialize_its_PFIC_Treatment_by_the_End_of_the_Year\"><\/span><strong>Albireo Pharma Hopeful to Commercialize its PFIC Treatment by the End of the Year<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Albireo Pharma, spun out of AstraZeneca, has long been working on developing potential and efficient treatment drugs for the patients suffering from <a href=\"https:\/\/www.delveinsight.com\/report-store\/progressive-familial-intrahepatic-cholestasis-pfic-market\" target=\"_blank\" rel=\"noreferrer noopener\">progressive familial intrahepatic cholestasis (PFIC)<\/a>, a rare disorder that leads to insidious liver failure. Now, it seems the dream of the company might come true.&nbsp;<\/p>\n\n\n\n<p>Positive results of Phase III trial PEDFIC 1 presented at the American Association for the Study of Liver Diseases\u2019 annual meeting demonstrated some promising outcomes. The data showed that the treatment with odevixibat,&nbsp; a potent, non-systemic ileal bile acid transport inhibitor (IBATi), statistically reduced the levels of serum bile acids (sBAs) and improved pruritus in pediatric PFIC patients. The drug met all its primary endpoints and as add-ons yielded consistent, durable, and continued promising results.&nbsp;<\/p>\n\n\n\n<p>In its endeavor to launch odevixibat in the PFIC market that currently holds no approved therapy for this rare and devastating disease, the company is looking forward to filing a New Drug Application with the U.S. FDA and the EMA in the early part of 2021. The company hopes to receive a priority review, thereby potential approval and launch by the end of 2020.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Accepts_Lupins_Supplemental_New_Drug_Application_Filed_for_Trichomoniasis_Treatment_Solosec\"><\/span><strong>FDA Accepts Lupin\u2019s Supplemental New Drug Application Filed for Trichomoniasis Treatment, Solosec&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>A U.S. based wholly-owned subsidiary of Lupin Limited, Lupin Pharmaceuticals shared good news regarding the acceptance of supplemental drug application for its drug solosec. The US FDA has issued the drug a Prescription Drug User Fee Act (PDUFA) target date of June 30, 2021.&nbsp;<\/p>\n\n\n\n<p>The company has been investigating Solosec (secnidazole) for the treatment of trichomoniasis in adults and adolescents. If approved, Solosec will be the first and only single-dose oral prescription treatment option available to treat patients suffering from Trichomoniasis vaginosis (BV), the most common non-viral, curable sexually transmitted infection (STI) in the U.S.<\/p>\n\n\n\n<p>The present<a href=\"https:\/\/www.delveinsight.com\/report-store\/trichomoniasis-market\" target=\"_blank\" rel=\"noreferrer noopener\"> trichomoniasis market<\/a> is dominated by antibiotics such as Metronidazole (Flagyl) or tinidazole (Tindamax). However, antimicrobial resistance is an emerging point of concern that hinders in altering the course of the disease. Thus, the trichomoniasis therapeutic market is in dire need of technological advancements stopped with a better and improved understanding of the disease. As per the analysis by DelveInsight, the trichomoniasis pipeline is scarce, and Lupin appears to be the only hope that has the potential to change the market dynamics with its oral treatment in the coming next decade.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Another_Hope_Lights_Up_as_Moderna_Declares_its_COVID-19_Vaccine_is_Over_94_Effective\"><\/span><strong>Another Hope Lights Up as Moderna Declares its COVID-19 Vaccine&nbsp; is Over 94% Effective<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>After Pfizer, Moderna today made a huge splash after announcing the interim results of the Phase III clinical trial (COVE) of its <a href=\"https:\/\/www.delveinsight.com\/blog\/coronavirus-vaccine-candidates\/\" target=\"_blank\" rel=\"noreferrer noopener\">COVID-19 vaccine<\/a> mRNA-1273. Shares of the company soared after the good news was shared.&nbsp;<\/p>\n\n\n\n<p>The company announced that the<em> trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%<\/em>. The trial enrolled over 30,000 patients in the U.S. and was being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). The results, however, are based on the first 95 to develop Covid-19 symptoms. Only five of these 95 were injected with the vaccine, the rest being given a dummy treatment. The vaccine was able to protect 94.5% of people.<\/p>\n\n\n\n<p>The results came hot on the heels of <a href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-for-biogen-pfizer-viiv-calliditas\/\" target=\"_blank\" rel=\"noreferrer noopener\">Pfizer\u2019s announcement<\/a> of its COVID-19 vaccine with efficiency over 90 percent, adding the second player to the list of those boosting the confidence to end the corona crises as early as possible. The company plans to move forward with emergency approval and prepare to provide approximately 20 million doses in the US by the end of 2020.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Gilead_Novo_Nordisks_Cocktail_Therapy_Starts_on_the_Road_to_be_a_Blockbuster_in_NASH_Market\"><\/span><strong>Gilead &amp; Novo Nordisk&#8217;s Cocktail Therapy Starts on the Road to be a Blockbuster in NASH Market&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Gilead and Novo Nordisk presented the results of Phase II proof-of-concept clinical trial testing semaglutide in combinations with Gilead\u2019s FXR agonist cilofexor and\/or Gilead\u2019s ACC inhibitor firsocostat in non-alcoholic steatohepatitis (NASH).&nbsp;<\/p>\n\n\n\n<p>Novo Nordisk\u2019s Semaglutide is a GLP-1 analog that along with stimulating the secretion of insulin also improves glucose metabolism in the liver and increases fatty acid oxidation. The trial evaluated the combinations in five arms, and all combinations were well-tolerated.&nbsp;<\/p>\n\n\n\n<p>The positive results bolster Gilead\u2019s confidence in fortifying the NASH pipeline, which has earned the tag of a hard nut to crack. The company acquired frisocostat from Nimbus Therapeutics and cilofexor from Phenex Pharmaceuticals. Another drug, that the company homes, is selonsertib, which failed to yield the desired results. As several other pharma players including Intercept, Genfit, Madrigal, and NGM Bio\/Merck are emerging as potential rivals in the <a href=\"https:\/\/www.delveinsight.com\/report-store\/nonalcoholic-steatohepatitis-nash-market\" target=\"_blank\" rel=\"noreferrer noopener\">NASH market<\/a>, it seems Gilead has not lost touch as it continues to crack the NASH puzzle.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Albireo Pharma Hopeful to Commercialize its PFIC Treatment by the End of the Year Albireo Pharma, spun out of AstraZeneca, has long been working on developing potential and efficient treatment drugs for the patients suffering from progressive familial intrahepatic cholestasis (PFIC), a rare disorder that leads to insidious liver failure. Now, it seems the dream [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":11217,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":3,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[15648,794,5900,877,16747,16746],"industry":[17225],"therapeutic_areas":[17231,17245,17228],"class_list":["post-11213","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-covid-19-vaccines","tag-gilead","tag-nash-upcoming-therapies","tag-novo-nordisk","tag-pfic","tag-trichomoniasis","industry-pharmaceutical","therapeutic_areas-infectious-diseases","therapeutic_areas-neurology","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.9 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Pharma News | Albireo, Lupin, Moderna, Gilead and Novo Nordisk\u2019<\/title>\n<meta name=\"description\" content=\"Albireo Pharma&#039;s PFIC Therapy; Lupin\u2019s Trichomoniasis Oral Drug; Moderna&#039;s Weapon Against COVID; Gilead\/Novo Nordisk&#039;s NASH Cocktail Therapy\" \/>\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\/recent-pharma-happenings-for-albireo-lupin-moderna-gilead-novo\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Albireo, Lupin, Moderna, Gilead and Novo Nordisk\u2019\" \/>\n<meta property=\"og:description\" content=\"Albireo Pharma&#039;s PFIC Therapy; Lupin\u2019s Trichomoniasis Oral Drug; Moderna&#039;s Weapon Against COVID; Gilead\/Novo Nordisk&#039;s NASH Cocktail Therapy\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-albireo-lupin-moderna-gilead-novo\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2020-11-17T06:27:57+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-02-10T06:17:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2020\/11\/17115511\/Albireos-PFIC-Therapy-Lupin%E2%80%99s-Trichomoniasis-Drug-Modernas-COVID-vaccine-NASH-Cocktail-Therapy.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"772\" \/>\n\t<meta property=\"og:image:height\" content=\"482\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Sandeep Joshi\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Sandeep Joshi\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Pharma News | Albireo, Lupin, Moderna, Gilead and Novo Nordisk\u2019","description":"Albireo Pharma's PFIC Therapy; 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