{"id":35431,"date":"2026-06-16T13:47:04","date_gmt":"2026-06-16T08:17:04","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=35431"},"modified":"2026-06-16T13:47:06","modified_gmt":"2026-06-16T08:17:06","slug":"pharma-news-for-astrazeneca-merck-jazz","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-merck-jazz","title":{"rendered":"Ultomiris Receives US Priority Review for Adult IgA Nephropathy Treatment; FDA Approves WELIREG Plus KEYTRUDA or KEYTRUDA QLEX for Adjuvant Treatment of Select ccRCC Patients; Jazz Pharmaceuticals Highlights Phase 3 LAGOON Trial Update for Zepzelca\u00ae in Second-Line SCLC; Novartis\u2019 delpacibart braxlosiran (del-brax) Achieves Primary Biomarker Endpoint in Phase I\/II FSHD Study; Takeda\u2019s Zasocitinib Tops Deucravacitinib in Phase 3 Psoriasis Trial, Setting a New Benchmark for Oral Therapies; IMAAVY Demonstrates Clinically Meaningful and Sustained Hemoglobin Responses in Pivotal wAIHA Study"},"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-6a3156e4a19cf\" 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-6a3156e4a19cf\"  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-astrazeneca-merck-jazz\/#Ultomiris_Secures_Priority_Review_Status_in_the_US_for_Adult_IgA_Nephropathy\" >Ultomiris Secures Priority Review Status in the US for Adult IgA Nephropathy<\/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-astrazeneca-merck-jazz\/#Merck_Secures_FDA_Approval_for_KEYTRUDA-WELIREG_Combination_in_Clear_Cell_Renal_Cell_Carcinoma\" >Merck Secures FDA Approval for KEYTRUDA-WELIREG Combination in Clear Cell Renal Cell 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-astrazeneca-merck-jazz\/#Jazz_Pharmaceuticals_Announces_Update_on_Zepzelca_Phase_3_LAGOON_Study_in_Second-Line_Small_Cell_Lung_Cancer\" >Jazz Pharmaceuticals Announces Update on Zepzelca Phase 3 LAGOON Study in Second-Line Small Cell Lung Cancer<\/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-astrazeneca-merck-jazz\/#Novartis_Reports_Phase_III_Success_for_del-brax_in_FSHD\" >Novartis Reports Phase I\/II Success for del-brax in FSHD<\/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-astrazeneca-merck-jazz\/#Takedas_Zasocitinib_Raises_the_Bar_in_Psoriasis_Market_with_Phase_3_Win_Over_Deucravacitinib\" >Takeda\u2019s Zasocitinib Raises the Bar in Psoriasis Market with Phase 3 Win Over Deucravacitinib<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-astrazeneca-merck-jazz\/#IMAAVY_Meets_Key_Efficacy_Goals_with_Sustained_Hemoglobin_Response_and_Early_Treatment_Effect_in_Pivotal_Phase_23_Trial\" >IMAAVY Meets Key Efficacy Goals with Sustained Hemoglobin Response and Early Treatment Effect in Pivotal Phase 2\/3 Trial<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-ultomiris-secures-priority-review-status-in-the-us-for-adult-iga-nephropathy\"><span class=\"ez-toc-section\" id=\"Ultomiris_Secures_Priority_Review_Status_in_the_US_for_Adult_IgA_Nephropathy\"><\/span>Ultomiris Secures Priority Review Status in the US for Adult IgA Nephropathy<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Alexion, AstraZeneca Rare Disease<\/strong> announced that the FDA has accepted and granted <strong>Priority Review to the supplemental Biologics License Application (sBLA)<\/strong> for <strong>Ultomiris <\/strong>as a potential treatment for adults with Immunoglobulin A Nephropathy. The FDA reserves Priority Review for therapies that may provide meaningful advances in safety, efficacy, or patient care compared with existing treatment options. A regulatory decision is expected in<strong> Q4 2026<\/strong> under the Prescription Drug User Fee Act (PDUFA) timeline.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.delveinsight.com\/report-store\/iga-nephropathy-igan-market\">IgAN<\/a> is a rare kidney disorder characterized by the accumulation of abnormal IgA-containing immune complexes in the kidneys, triggering complement-mediated inflammation and progressive kidney damage. The disease can ultimately lead to chronic kidney disease and end-stage kidney failure. More than 217,000 individuals in the United States are estimated to have a diagnosis of IgAN.<\/p>\n\n\n\n<p>The filing is supported by findings from a prespecified interim analysis of the <strong>Phase III I CAN study,<\/strong> recently presented at the <strong>2026 European Renal Association Congress<\/strong>. In the trial, Ultomiris achieved a 46.6% reduction in 24-hour urine protein-creatinine ratio (UPCR) from baseline at Week 34, compared with a 5.6% reduction in the placebo group, corresponding to a placebo-adjusted treatment effect of 43.4% (p&lt;0.0001).<\/p>\n\n\n\n<p>Proteinuria reductions were evident as early as Week 10 and remained durable through Week 34. Treatment benefits were observed consistently across patient subgroups regardless of demographic characteristics, baseline disease severity, or clinical profile. The study\u2019s primary endpoint assessing change in estimated glomerular filtration rate (eGFR) will be evaluated at Week 106. Safety findings from the I CAN trial were in line with the established safety profile of Ultomiris, with the therapy generally well tolerated and no new safety signals reported.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-merck-secures-fda-approval-for-keytruda-welireg-combination-in-clear-cell-renal-cell-carcinoma\"><span class=\"ez-toc-section\" id=\"Merck_Secures_FDA_Approval_for_KEYTRUDA-WELIREG_Combination_in_Clear_Cell_Renal_Cell_Carcinoma\"><\/span>Merck Secures FDA Approval for KEYTRUDA-WELIREG Combination in Clear Cell Renal Cell Carcinoma<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Merck<\/strong>, known as MSD outside the U.S. and Canada, announced that the U.S. FDA has approved both <strong>KEYTRUDA\u00ae <\/strong>(pembrolizumab)<strong> and KEYTRUDA QLEX<\/strong>\u2122 (pembrolizumab and berahyaluronidase alfa-pmph) in combination with <strong>WELIREG\u00ae (belzutifan)<\/strong> for the adjuvant <a href=\"https:\/\/www.delveinsight.com\/report-store\/renal-cell-carcinoma-market\">treatment of adults with clear cell renal cell carcinoma (ccRCC)<\/a> at intermediate-high or high risk of recurrence following nephrectomy, with or without resection of metastatic lesions. The approval marks the first use of WELIREG in earlier-stage ccRCC and the first approved combination of a PD-1 inhibitor with a HIF-2\u03b1 inhibitor.<\/p>\n\n\n\n<p>The approval was supported by findings from the <strong>Phase III LITESPARK-022 trial<\/strong>, which involved 1,841 patients. The study showed that KEYTRUDA plus WELIREG significantly improved disease-free survival (DFS), reducing the risk of recurrence, metastasis, or death by 28% compared with KEYTRUDA plus placebo (HR=0.72; p=0.0003). At 24 months, the DFS rate was 81% with the combination regimen versus 74% with placebo, while median DFS had not yet been reached in either group. Overall survival data remain immature at this interim analysis. Approval of KEYTRUDA QLEX was further supported by studies demonstrating comparable pharmacokinetics, efficacy, and safety to KEYTRUDA.<\/p>\n\n\n\n<p>WELIREG carries a boxed warning for embryo-fetal toxicity and may cause severe anemia and hypoxia, necessitating regular monitoring during treatment. Patients should be advised regarding pregnancy risks and the use of effective non-hormonal contraception, as WELIREG may reduce the effectiveness of certain hormonal contraceptives. KEYTRUDA and KEYTRUDA QLEX are associated with significant immune-mediated adverse events affecting multiple organ systems, severe infusion or injection-related reactions, transplant-related complications, embryo-fetal toxicity, and increased mortality when used in certain multiple myeloma treatment combinations outside controlled clinical trials.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-jazz-pharmaceuticals-announces-update-on-zepzelca-phase-3-lagoon-study-in-second-line-small-cell-lung-cancer\"><span class=\"ez-toc-section\" id=\"Jazz_Pharmaceuticals_Announces_Update_on_Zepzelca_Phase_3_LAGOON_Study_in_Second-Line_Small_Cell_Lung_Cancer\"><\/span>Jazz Pharmaceuticals Announces Update on Zepzelca Phase 3 LAGOON Study in Second-Line Small Cell Lung Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Jazz Pharmaceuticals plc<\/strong> announced topline findings from the <strong>Phase III LAGOON study<\/strong>, sponsored by <strong>PharmaMar<\/strong>, assessing <strong>Zepzelca\u00ae (lurbinectedin)<\/strong> in patients with relapsed (second-line) <a href=\"https:\/\/www.delveinsight.com\/report-store\/small-cell-lung-cancer-market\">metastatic small cell lung cancer (SCLC)<\/a>. The study failed to achieve its primary endpoint of overall survival (OS), whether Zepzelca was administered alone or in combination with irinotecan, compared with investigator-selected treatment options of topotecan or irinotecan. Safety outcomes were consistent with the established profiles of the therapies involved, and no new safety concerns were observed.<\/p>\n\n\n\n<p>Zepzelca received full U.S. approval in 2025 based on results from the <strong>Phase III IMforte trial<\/strong>, which evaluated Zepzelca plus atezolizumab as first-line maintenance therapy for extensive-stage SCLC. In IMforte, the combination demonstrated statistically significant improvements in both OS and progression-free survival (PFS) versus atezolizumab alone, reducing the risk of disease progression or death by 46% and the risk of death by 27%. Jazz emphasized that the LAGOON findings are unrelated to the IMforte study and do not affect Zepzelca\u2019s approved use in the first-line maintenance setting.<\/p>\n\n\n\n<p>The company has submitted the LAGOON data to the FDA and plans to engage with the agency regarding the post-marketing commitments associated with Zepzelca\u2019s second-line SCLC indication.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-novartis-reports-phase-i-ii-success-for-del-brax-in-fshd\"><span class=\"ez-toc-section\" id=\"Novartis_Reports_Phase_III_Success_for_del-brax_in_FSHD\"><\/span>Novartis Reports Phase I\/II Success for del-brax in FSHD<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Novartis <\/strong>reported positive results from the biomarker cohort of the <strong>Phase I\/II FORTITUDE trial<\/strong> evaluating <strong>del-brax<\/strong>, achieving both primary and key secondary endpoints. The study demonstrated reductions in KHDC1L (cDUX) and creatine kinase biomarkers, suggesting robust target engagement and decreased muscle damage in patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/facioscapulohumeral-muscular-dystrophy-market\">facioscapulohumeral muscular dystrophy (FSHD)<\/a>. Del-brax, an investigational antibody oligonucleotide conjugate (AOC), has the potential to become the first disease-modifying therapy for FSHD, a rare neuromuscular disorder characterized by progressive muscle deterioration and disability.<\/p>\n\n\n\n<p>Designed to target the underlying cause of FSHD by suppressing aberrant DUX4 expression, del-brax combines monoclonal antibody specificity with oligonucleotide precision to deliver siRNA directly to affected muscle cells. It remains the only clinical-stage candidate to demonstrate disease-modifying potential in FSHD and has received<strong> Orphan Drug and Fast Track designation<\/strong> from the FDA, as well as Orphan Drug designation from the EMA. The therapy is currently advancing through Phase III development.<\/p>\n\n\n\n<p>Del-brax joined Novartis\u2019 neuroscience portfolio through its acquisition of Avidity Biosciences in February 2026. The acquisition also added two other late-stage AOC candidates: del-desiran, a Phase III therapy for myotonic dystrophy type 1 (DM1), and del-zota, a Phase II therapy for Duchenne muscular dystrophy (DMD). Together with Novartis\u2019 established expertise in spinal muscular atrophy, these programs strengthen the company&#8217;s position in neuromuscular disease therapeutics and expand its pipeline of potential first-in-class disease-modifying treatments.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-takeda-s-zasocitinib-raises-the-bar-in-psoriasis-market-with-phase-3-win-over-deucravacitinib\"><span class=\"ez-toc-section\" id=\"Takedas_Zasocitinib_Raises_the_Bar_in_Psoriasis_Market_with_Phase_3_Win_Over_Deucravacitinib\"><\/span>Takeda\u2019s Zasocitinib Raises the Bar in Psoriasis Market with Phase 3 Win Over Deucravacitinib<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Takeda <\/strong>reported positive topline findings from the <strong>Phase III LATITUDE Atlas trial <\/strong>evaluating <strong>zasocitinib (TAK-279)<\/strong>, a next-generation, highly selective <a href=\"https:\/\/www.delveinsight.com\/report-store\/tyrosine-kinase-2-tyk2-inhibitors-market-forecast\">oral TYK2 inhibitor<\/a>, against <strong>deucravacitinib <\/strong>in adults with moderate-to-severe plaque psoriasis. The study met its primary endpoint, with zasocitinib demonstrating statistically superior PASI 100 response rates at Week 16. The therapy also outperformed deucravacitinib across key secondary endpoints, including PASI 90 and sPGA 0 responses, while maintaining a favorable safety and tolerability profile with no new safety concerns identified.<\/p>\n\n\n\n<p>According to investigators, the head-to-head trial highlighted clinically meaningful improvements in skin clearance with zasocitinib compared with deucravacitinib, underscoring its potential to elevate treatment expectations for oral psoriasis therapies. More than 35% of patients receiving zasocitinib achieved complete skin clearance (PASI 100) at Week 16, over 2.5 times the response rate observed with deucravacitinib, with treatment benefits emerging as early as Week 8.<\/p>\n\n\n\n<p>Takeda plans to present detailed results at upcoming scientific meetings and remains on track to submit regulatory applications for plaque psoriasis in the U.S. and other markets beginning this fiscal year.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-imaavy-meets-key-efficacy-goals-with-sustained-hemoglobin-response-and-early-treatment-effect-in-pivotal-phase-2-3-trial\"><span class=\"ez-toc-section\" id=\"IMAAVY_Meets_Key_Efficacy_Goals_with_Sustained_Hemoglobin_Response_and_Early_Treatment_Effect_in_Pivotal_Phase_23_Trial\"><\/span>IMAAVY Meets Key Efficacy Goals with Sustained Hemoglobin Response and Early Treatment Effect in Pivotal Phase 2\/3 Trial<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Johnson &amp; Johnson<\/strong> reported the first full results from the <strong>Phase 2\/3 ENERGY trial<\/strong>, demonstrating that <strong>IMAAVY (nipocalimab-aahu)<\/strong> achieved a statistically significant and durable hemoglobin (Hb) response with a rapid onset of action in <a href=\"https:\/\/www.delveinsight.com\/report-store\/warm-autoimmune-hemolytic-anemia-waiha-market\">patients with warm autoimmune hemolytic anemia (wAIHA)<\/a> receiving the 30 mg\/kg dose compared with placebo. The randomized, placebo-controlled study showed that nearly three times more patients receiving IMAAVY attained sustained Hb responses by Week 24 versus placebo. Patients treated with IMAAVY also experienced an average Hb increase of at least 1 g\/dL as early as the first week of treatment.<\/p>\n\n\n\n<p>The findings, scheduled for presentation at the European Hematology Association (EHA) 2026 Congress, represent a notable advancement for individuals with wAIHA, a rare and potentially life-threatening disorder that currently lacks any FDA-approved therapies.<\/p>\n\n\n\n<p><strong>Key Results from the ENERGY Study<\/strong><\/p>\n\n\n\n<p>The ENERGY trial evaluated IMAAVY against placebo using a stringent primary endpoint of durable Hb improvement, defined by:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>An Hb increase of at least 2 g\/dL from baseline<\/li>\n\n\n\n<li>Hb levels reaching at least 10 g\/dL<\/li>\n\n\n\n<li>Achievement of these criteria at a minimum of three visits over at least 28 days, beginning by Week 16<\/li>\n\n\n\n<li>No requirement for rescue therapy or modifications to background wAIHA treatments<\/li>\n<\/ul>\n\n\n\n<p>Patients receiving the 30 mg\/kg dose achieved an average Hb increase of 1 g\/dL by Week 1, while no meaningful change was observed in the placebo arm. By Week 24, almost two-thirds of treated patients reached both key treatment goals, maintaining Hb levels of at least 10 g\/dL and achieving a minimum 2 g\/dL improvement from baseline.<\/p>\n\n\n\n<p>Beyond improvements in anemia, IMAAVY also demonstrated benefits in reducing fatigue and lowering steroid use, both important secondary endpoints. Patient-reported fatigue improvements emerged as early as Week 2 and were maintained throughout the 24-week treatment period. The safety profile of IMAAVY in wAIHA was consistent with its established profile in patients with generalized myasthenia gravis. The most frequently reported adverse events (occurring in at least 10% of patients) included peripheral edema, diarrhea, and pyrexia.<\/p>\n\n\n\n<p>IMAAVY works by selectively targeting pathogenic IgG autoantibodies responsible for red blood cell destruction in wAIHA. This immunoselective mechanism is designed to preserve essential humoral immune functions while addressing the underlying disease process, offering a differentiated therapeutic approach in a setting where treatment options are largely limited to off-label corticosteroids and broad immunosuppressive agents.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ultomiris Secures Priority Review Status in the US for Adult IgA Nephropathy Alexion, AstraZeneca Rare Disease announced that the FDA has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for Ultomiris as a potential treatment for adults with Immunoglobulin A Nephropathy. The FDA reserves Priority Review for therapies that may provide [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":35432,"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":[17434],"tags":[21458,18841,349,639,854,1701,11979],"industry":[17225],"therapeutic_areas":[17230,17233,17228],"class_list":["post-35431","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-facts-and-figures","tag-facioscapulohumeral-muscular-dystrophy","tag-iga-nephropathy","tag-latest-pharma-news","tag-pharma-news","tag-renal-cell-carcinoma","tag-small-cell-lung-cancer","tag-warm-autoimmune-hemolytic-anemia","industry-pharmaceutical","therapeutic_areas-genito-urinary-system-and-sex-hormones","therapeutic_areas-hematological-disorders","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>Pharma News | AstraZeneca, Merck, Jazz Pharmaceuticals<\/title>\n<meta name=\"description\" content=\"AstraZeneca\u2019s Ultomiris; Merck\u2019s KEYTRUDA-WELIREG Combo; Jazz\u2019s Zepzelca; Novartis\u2019 del-brax; Takeda\u2019s Zasocitinib; J&amp;J\u2019s IMAAVY\" \/>\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-astrazeneca-merck-jazz\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | AstraZeneca, Merck, Jazz Pharmaceuticals\" \/>\n<meta property=\"og:description\" content=\"AstraZeneca\u2019s Ultomiris; Merck\u2019s KEYTRUDA-WELIREG Combo; Jazz\u2019s Zepzelca; Novartis\u2019 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