{"id":29338,"date":"2024-08-27T16:12:16","date_gmt":"2024-08-27T10:42:16","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=29338"},"modified":"2024-08-27T16:12:18","modified_gmt":"2024-08-27T10:42:18","slug":"pharma-news-for-merck-pfizer-novartis","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-merck-pfizer-novartis","title":{"rendered":"Merck\u2019s WINREVAIR\u2122 EU Approval; BALVERSA for Urothelial Carcinoma; Novartis and Versant\u2019s Borealis Launched; Moderna\u2019s RSV mRESVIA\u00ae EU Approval; FDA Nods RYBREVANT\u00ae and LAZCLUZE\u2122 for EGFR-mutated Lung Cancer"},"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-6a082ddbacac6\" 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-6a082ddbacac6\"  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-news-for-merck-pfizer-novartis\/#Mercks_WINREVAIR_Approved_by_the_European_Commission_for_PAH_in_Adults_with_Functional_Class_II-III\" >Merck\u2019s WINREVAIR Approved by the European Commission for PAH in Adults with Functional Class II-III<\/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-news-for-merck-pfizer-novartis\/#European_Commission_Approves_BALVERSA_for_Adult_Patients_With_Unresectable_or_Metastatic_Urothelial_Carcinoma\" >European Commission Approves BALVERSA for Adult Patients With Unresectable or Metastatic Urothelial Carcinoma<\/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-news-for-merck-pfizer-novartis\/#Novartis_Versant_Launch_RNA_Kidney_Medicines%E2%80%94Focused_Borealis\" >Novartis, Versant Launch RNA Kidney Medicines\u2014Focused Borealis<\/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-news-for-merck-pfizer-novartis\/#Moderna_Receives_European_Commission_Approval_for_RSV_Vaccine_mRESVIAR\" >Moderna Receives European Commission Approval for RSV Vaccine mRESVIA(R)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-merck-pfizer-novartis\/#FDA_Approves_RYBREVANT%C2%AE_and_LAZCLUZE%E2%84%A2_as_a_First-line_Chemotherapy-free_Treatment_for_EGFR-mutated_Advanced_Lung_Cancer\" >FDA Approves RYBREVANT\u00ae and LAZCLUZE\u2122 as a First-line, Chemotherapy-free Treatment for EGFR-mutated Advanced Lung Cancer<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-merck-s-winrevair-approved-by-the-european-commission-for-pah-in-adults-with-functional-class-ii-iii\"><span class=\"ez-toc-section\" id=\"Mercks_WINREVAIR_Approved_by_the_European_Commission_for_PAH_in_Adults_with_Functional_Class_II-III\"><\/span>Merck\u2019s WINREVAIR Approved by the European Commission for PAH in Adults with Functional Class II-III<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Merck has secured European Commission (EC) approval for <a href=\"https:\/\/www.delveinsight.com\/blog\/winrevair-for-pulmonary-arterial-hypertension-treatment\">WINREVAIR\u2122 (sotatercept), <\/a>marking it as the first activin signaling inhibitor therapy for <a href=\"https:\/\/www.delveinsight.com\/report-store\/pulmonary-arterial-hypertension-market\">pulmonary arterial hypertension (PAH)<\/a> approved across all 27 EU member states, plus Iceland, Liechtenstein, and Norway. WINREVAIR is indicated for adult patients with WHO Functional Class II to III PAH and is designed to improve exercise capacity by balancing pro- and anti-proliferative signaling in vascular cells. This approval is based on positive results from the Phase III STELLAR trial.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Dr. Joerg Koglin from Merck highlighted the significance of this approval, stating, \u201cWINREVAIR is the first therapy targeting the activin signaling pathway. We are proud to bring this innovative treatment to more patients.\u201d The STELLAR trial demonstrated that WINREVAIR, when added to standard PAH therapies, significantly improved six-minute walk distance by 40.8 meters and reduced the risk of death or clinical worsening by 82% compared to placebo.<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>In addition to the European approval, WINREVAIR was also granted FDA approval in the U.S. on March 26, 2024. Dr. Marc Humbert of Universit\u00e9 Paris-Saclay emphasized the impact of the treatment, stating, \u201cWINREVAIR should be considered as a new standard of care for treating PAH patients.\u201d WINREVAIR is administered every three weeks via a single injection and can be given by patients or caregivers with proper training.<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-european-commission-approves-balversa-for-adult-patients-with-unresectable-or-metastatic-urothelial-carcinoma\"><span class=\"ez-toc-section\" id=\"European_Commission_Approves_BALVERSA_for_Adult_Patients_With_Unresectable_or_Metastatic_Urothelial_Carcinoma\"><\/span>European Commission Approves BALVERSA for Adult Patients With Unresectable or Metastatic Urothelial Carcinoma<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Janssen-Cilag International NV, a Johnson &amp; Johnson company, announced that the European Commission (EC) has approved BALVERSA\u00ae (erdafitinib) as a once-daily oral monotherapy for adult patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-urothelial-carcinoma-market\">unresectable or metastatic urothelial carcinoma (mUC)<\/a> harboring FGFR3 genetic alterations. This approval targets patients who have previously undergone at least one line of therapy with a PD-1 or PD-L1 inhibitor.&nbsp;<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Dr. Yohann Loriot from Institut Gustave Roussy commented, \u201cBladder cancer is one of Europe\u2019s most common cancers, and the need for innovative treatment options remains high. Erdafitinib is a novel, targeted therapy that has been shown to significantly improve overall and progression-free survival for patients with FGFR3 alterations.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The approval is based on the Phase III THOR study results, which demonstrated that erdafitinib significantly improved median overall survival (OS) to 12.1 months compared to 7.8 months with chemotherapy. Additionally, median progression-free survival (PFS) was 5.6 months with erdafitinib versus 2.7 months with chemotherapy. Serious treatment-related adverse events were lower with erdafitinib, showing a better overall response rate than chemotherapy.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Henar Hevia from Johnson &amp; Johnson emphasized, \u201cThe approval of erdafitinib as a precision therapy further highlights the importance of FGFR testing for all patients with metastatic urothelial cancer.\u201d Kiran Patel, Vice President at Johnson &amp; Johnson, added, \u201cThe EC approval of erdafitinib reflects our unwavering commitment to transforming outcomes for people living with unresectable or metastatic urothelial carcinoma.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-novartis-versant-launch-rna-kidney-medicines-focused-borealis\"><span class=\"ez-toc-section\" id=\"Novartis_Versant_Launch_RNA_Kidney_Medicines%E2%80%94Focused_Borealis\"><\/span>Novartis, Versant Launch RNA Kidney Medicines\u2014Focused Borealis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Novartis and Versant Ventures have announced the launch of Borealis Biosciences, a new biotech company focused on developing RNA therapeutics for kidney diseases, with $150 million in Series A financing. This collaboration builds on their previous success with Chinook Therapeutics, which Versant founded in 2019 and was acquired by Novartis in 2023 for $3.2 billion, plus an additional $300 million in potential milestones. The new venture aims to address unmet needs in kidney disease treatment by leveraging RNA-based technologies.<\/p>\n\n\n\n<p>Borealis Biosciences will utilize Novartis&#8217; xRNA platform, which modulates disease-causing proteins through natural mRNA. Despite progress with drugs like atrasentan, which is under FDA review for <a href=\"https:\/\/www.delveinsight.com\/report-store\/iga-nephropathy-market\">immunoglobulin A nephropathy (IgAN)<\/a>, traditional therapies have struggled with certain targets.&nbsp;<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Jerel Davis from Versant, who will oversee operations at Borealis, noted, \u201cWe\u2019ve recognized over the last six years that some of the most validated targets for kidney disease have been out of reach with traditional modalities.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>The company will operate out of a 23,000-square-foot facility in Vancouver previously used by Chinook. Novartis has committed up to $100 million upfront, with additional funding for research, and will have the option to acquire up to two Borealis programs for up to $750 million in total. Ronny Gal from Novartis highlighted the deal as a testament to the company\u2019s commitment to advancing renal science, stating, \u201cA first of its kind for Novartis, this three-part transaction of divestment, collaboration and investment is a testament to our company\u2019s unwavering focus on advancing renal science.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-moderna-receives-european-commission-approval-for-rsv-vaccine-mresvia-r\"><span class=\"ez-toc-section\" id=\"Moderna_Receives_European_Commission_Approval_for_RSV_Vaccine_mRESVIAR\"><\/span>Moderna Receives European Commission Approval for RSV Vaccine mRESVIA(R)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Moderna, Inc. has received marketing authorization from the European Commission (EC) for mRESVIA\u00ae (mRNA-1345), an mRNA vaccine designed to protect adults aged 60 and older from lower respiratory tract disease caused by <a href=\"https:\/\/www.delveinsight.com\/report-store\/respiratory-syncytial-virus-rsv-market\">respiratory syncytial virus (RSV)<\/a>. This authorization follows a Positive Opinion from the European Medicines Agency&#8217;s (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.&nbsp;<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>St\u00e9phane Bancel, Moderna\u2019s CEO, stated, \u201cThe European Commission&#8217;s approval of mRESVIA is an important milestone for public health and highlights Moderna&#8217;s mRNA leadership.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>RSV is a highly contagious virus leading to significant disease burden in both infants and older adults, with an estimated 160,000 hospital admissions annually in the EU, predominantly among those aged 65 and over. The marketing authorization is supported by data from the Phase III ConquerRSV trial, involving around 37,000 adults. The trial showed an 83.7% vaccine efficacy against RSV lower respiratory tract disease during the initial follow-up period and sustained efficacy of 63.3% in extended follow-up. The most common side effects were injection site pain, fatigue, headache, myalgia, and arthralgia.<\/p>\n\n\n\n<p>In addition to European approval, mRESVIA was also approved by the FDA in May 2024 under a breakthrough therapy designation, marking Moderna&#8217;s second approved mRNA product. Moderna continues to seek marketing authorization for mRNA-1345 in various global markets.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-rybrevant-and-lazcluze-as-a-first-line-chemotherapy-free-treatment-for-egfr-mutated-advanced-lung-cancer\"><span class=\"ez-toc-section\" id=\"FDA_Approves_RYBREVANT%C2%AE_and_LAZCLUZE%E2%84%A2_as_a_First-line_Chemotherapy-free_Treatment_for_EGFR-mutated_Advanced_Lung_Cancer\"><\/span>FDA Approves RYBREVANT\u00ae and LAZCLUZE\u2122 as a First-line, Chemotherapy-free Treatment for EGFR-mutated Advanced Lung Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Johnson &amp; Johnson announced that the FDA has approved RYBREVANT\u00ae (amivantamab-vmjw) in combination with LAZCLUZE\u2122 (lazertinib) for the first-line treatment of adults with <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-non-small-cell-lung-cancer-market\">locally advanced or metastatic non-small cell lung cancer (NSCLC)<\/a> with EGFR exon 19 deletions or exon 21 L858R mutations. This approval marks the first multitargeted, chemotherapy-free regimen demonstrated to be superior to osimertinib for treating EGFR-mutated NSCLC.&nbsp;<\/p>\n\n\n\n<p>The approval is based on positive results from the Phase III MARIPOSA study, which showed that RYBREVANT\u00ae plus LAZCLUZE\u2122 reduced the risk of disease progression or death by 30% compared to osimertinib, with a median progression-free survival of 23.7 months versus 16.6 months. The median duration of response was also significantly longer with the combination therapy.&nbsp;<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Dr. Alexander Spira, a study investigator, highlighted the therapy\u2019s potential to set a new standard of care, stating, \u201cPatients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Jennifer Taubert, Executive Vice President at Johnson &amp; Johnson, emphasized the significance of this approval, noting, \u201cRYBREVANT plus LAZCLUZE establishes a new benchmark in the advanced first-line setting.\u201d John Reed, EVP of Innovative Medicine R&amp;D, added, \u201cToday\u2019s FDA approval of chemotherapy-free RYBREVANT plus LAZCLUZE in the first line is an incredible step towards our goal of altering the trajectory of lung cancer.\u201d The combination&#8217;s safety profile was consistent with that of the individual treatments, with venous thromboembolic events observed.<\/em><\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>Merck\u2019s WINREVAIR Approved by the European Commission for PAH in Adults with Functional Class II-III Merck has secured European Commission (EC) approval for WINREVAIR\u2122 (sotatercept), marking it as the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH) approved across all 27 EU member states, plus Iceland, Liechtenstein, and Norway. WINREVAIR is indicated for [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":29339,"comment_status":"closed","ping_status":"closed","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":[204,704,18841,349,20539,420,6733,639,499,5789,17615],"industry":[17225],"therapeutic_areas":[17242,17231,17228,17243],"class_list":["post-29338","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-delveinsight","tag-fda","tag-iga-nephropathy","tag-latest-pharma-news","tag-metastatic-urothelial-carcinoma","tag-news","tag-non-small-cell-lung-cancer","tag-pharma-news","tag-pulmonary-arterial-hypertension","tag-recent-pharma-news","tag-respiratory-syncytial-virus","industry-pharmaceutical","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-infectious-diseases","therapeutic_areas-oncology","therapeutic_areas-respiratory-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>Pharma News | Merck, Pfizer, Novartis<\/title>\n<meta name=\"description\" content=\"Merck\u2019s WINREVAIR, J&amp;J\u2019s BALVERSA, Novartis &amp; Versant\u2019s Borealis, Moderna\u2019s mRESVIA\u00ae, J&amp;J\u2019s RYBREVANT\u00ae &amp; LAZCLUZE\u2122\" \/>\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-news-for-merck-pfizer-novartis\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Merck, Pfizer, Novartis\" \/>\n<meta property=\"og:description\" content=\"Merck\u2019s WINREVAIR, J&amp;J\u2019s BALVERSA, Novartis &amp; Versant\u2019s Borealis, Moderna\u2019s mRESVIA\u00ae, J&amp;J\u2019s 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