{"id":31569,"date":"2025-04-29T21:03:18","date_gmt":"2025-04-29T15:33:18","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=31569"},"modified":"2025-04-29T21:04:03","modified_gmt":"2025-04-29T15:34:03","slug":"pharma-news-for-boston-scientific-roche-northstrive","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-boston-scientific-roche-northstrive","title":{"rendered":"Boston Scientific Pushes Forward Despite $200M Tariff Challenge; Northstrive Biosciences Gets FDA Green Light to Advance EL-22 Obesity Trial; Roche Acts Swiftly to Offset U.S. Tariff Impact with Global Engagements; Verastem Oncology Secures IND Clearance for KRAS G12D Inhibitor Trial; BlackfinBio Gets FDA OK for Phase I\/II Trial of BFB-101 in SPG47"},"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-69f181a5471db\" 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-69f181a5471db\"  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-boston-scientific-roche-northstrive\/#Boston_Scientific_Pushes_Forward_Despite_200M_Tariff_Challenge\" >Boston Scientific Pushes Forward Despite $200M Tariff Challenge<\/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-boston-scientific-roche-northstrive\/#Northstrive_Biosciences_Gets_FDA_Green_Light_to_Advance_EL-22_Obesity_Trial\" >Northstrive Biosciences Gets FDA Green Light to Advance EL-22 Obesity Trial<\/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-boston-scientific-roche-northstrive\/#Roche_Acts_Swiftly_to_Offset_US_Tariff_Impact_with_Global_Engagements\" >Roche Acts Swiftly to Offset U.S. Tariff Impact with Global Engagements<\/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-boston-scientific-roche-northstrive\/#Verastem_Oncology_Secures_IND_Clearance_for_KRAS_G12D_Inhibitor_Trial\" >Verastem Oncology Secures IND Clearance for KRAS G12D Inhibitor Trial<\/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-boston-scientific-roche-northstrive\/#BlackfinBio_Gets_FDA_Clearance_for_Phase_III_Trial_of_BFB-101_in_Hereditary_Spastic_Paraplegia_Type_47\" >BlackfinBio Gets FDA Clearance for Phase I\/II Trial of BFB-101 in Hereditary Spastic Paraplegia, Type 47<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-boston-scientific-pushes-forward-despite-200m-tariff-challenge\"><span class=\"ez-toc-section\" id=\"Boston_Scientific_Pushes_Forward_Despite_200M_Tariff_Challenge\"><\/span>Boston Scientific Pushes Forward Despite $200M Tariff Challenge<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Boston Scientific<\/strong> has announced that <strong>tariffs<\/strong> are expected to add approximately<strong> $200 million <\/strong>to its <strong>costs <\/strong>this year, but the company remains <strong>confident <\/strong>in its ability to <strong>absorb the financial hit<\/strong>. Despite the tariff burden, the company reported robust growth across its cardiology and urology divisions, reflecting strong overall performance.<\/p>\n\n\n\n<p>In its<strong> Q1 2025 <\/strong>earnings report, the company posted total sales of<strong> $4.66 billion, a 22.2% <\/strong>increase from the previous year. Significant contributions came from its medical-surgical division, which saw urology net sales rise by<strong> 24.5%,<\/strong> partly driven by its kidney stone treatment devices. Meanwhile, cardiovascular revenue surged to<strong> $3.09 billion<\/strong>, with electrophysiology sales jumping by<strong> 145%<\/strong>, fueled by the success of its Farapulse pulsed field ablation system.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong><em>CEO Mike Mahoney <\/em><\/strong><em>expressed confidence in the company\u2019s ability to manage the tariff costs. &#8220;Our ability to absorb the tariffs, I think, is more unique than most companies, given the strength of the growth and the leverage that we&#8217;re driving,\u201d Mahoney noted during the earnings call. He added that while the tariffs are \u201cunfortunate,\u201d the company\u2019s global manufacturing presence and strong operations allow it to maintain high performance.<\/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>He further emphasized, &#8220;There&#8217;s no major adjustments other than continuing investments to support the long-term growth of the company.&#8221; Mahoney also mentioned strategic reductions in discretionary spending, such as cutting back on travel, while maintaining its global manufacturing footprint, including investments in new facilities in Georgia and expanding its capacity in Minnesota.<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-northstrive-biosciences-gets-fda-green-light-to-advance-el-22-obesity-trial\"><span class=\"ez-toc-section\" id=\"Northstrive_Biosciences_Gets_FDA_Green_Light_to_Advance_EL-22_Obesity_Trial\"><\/span>Northstrive Biosciences Gets FDA Green Light to Advance EL-22 Obesity Trial<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Northstrive Biosciences<\/strong>, a subsidiary of <strong>PMGC Holdings Inc.<\/strong> announced that it has received <strong>preliminary feedback<\/strong> from the <strong>FDA<\/strong> regarding its <strong>Type B pre-Investigational New Drug (pre-IND) meeting<\/strong>. The meeting was requested to discuss its clinical development plans for <strong>EL-22<\/strong>, a novel engineered probiotic, administered in combination with <strong>GLP-1 receptor agonists<\/strong> for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/weight-loss-weight-management-obesity-market\"><strong>treatment of obesity.<\/strong><\/a><\/p>\n\n\n\n<p>The FDA\u2019s responses confirmed that Northstrive\u2019s <strong>pharmacology studies<\/strong> support <strong>EL-22\u2019s activity<\/strong> and that the <strong>nonclinical studies<\/strong> are sufficient to support its safety and efficacy in <strong>overweight and obese human populations<\/strong>. Based on this positive feedback, Northstrive plans to proceed with the <strong>IND application<\/strong> in 2025, followed by a <strong>Phase II clinical trial<\/strong> to assess the combination therapy in patients. The company is currently engaging with <strong>cGMP manufacturing partners<\/strong> to prepare for <strong>EL-22 production<\/strong>.<\/p>\n\n\n\n<p>EL-22 is designed to express myostatin on its surface, targeting the myostatin pathway to support muscle health, a critical concern for patients undergoing weight loss treatments like GLP-1 receptor agonists. Preclinical studies, including research in mdx mice and a completed Phase I trial in South Korea, have shown promising results in terms of safety and efficacy.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong><em>Deniel Mero<\/em><\/strong><em>, Co-founder of Northstrive Biosciences, commented, \u201cThis positive reinforcement from the FDA is a critical milestone in the development of EL-22 to address obesity\u2019s unmet need of preserving muscle during weight loss treatment, particularly for patients on GLP-1 therapies.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-roche-acts-swiftly-to-offset-u-s-tariff-impact-with-global-engagements\"><span class=\"ez-toc-section\" id=\"Roche_Acts_Swiftly_to_Offset_US_Tariff_Impact_with_Global_Engagements\"><\/span>Roche Acts Swiftly to Offset U.S. Tariff Impact with Global Engagements<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Roche <\/strong>is actively working to mitigate the <strong><em>impact of tariffs<\/em><\/strong><strong> <\/strong>by moving production of its medicines to the U.S. and seeking an exemption from the Trump administration. CEO <strong>Thomas Schinecker<\/strong> explained that Roche is negotiating with the U.S. government to avoid tariff consequences, proposing that if the company exports as much as it imports, it should be exempt from the tariffs. Schinecker added that Roche&#8217;s strong U.S. manufacturing presence gives the company the ability to absorb the $200 million tariff cost.<\/p>\n\n\n\n<p>The company is also engaged in discussions with governments in <strong>Switzerland<\/strong>, <strong>China<\/strong>, and the <strong>EU<\/strong> about the broader impact of tariffs. In conjunction with these talks, Roche has pledged a <strong>$50 billion investment<\/strong> over five years to expand manufacturing and R&amp;D facilities in the U.S., marking a strategic move to strengthen its local operations. Roche has already started shifting its pharmaceutical production to the U.S. as part of this effort.<\/p>\n\n\n\n<p>Roche\u2019s focus on mitigating tariff exposure includes increasing U.S. manufacturing for four of its medicines, which represent <strong>92% of its potential tariff impact<\/strong>. For three of these drugs, Roche plans to boost domestic production, while for the fourth, the company has begun a <strong>tech transfer<\/strong> to enable U.S. production. Schinecker stated, \u201cWe are operating in the U.S. at 50% drug substance capacity,\u201d which provides ample room to scale up manufacturing.<\/p>\n\n\n\n<p>Roche&#8217;s <strong>$50 billion U.S. investment<\/strong> does not affect its capital expenditure budget, which remains at <strong>3.5 to 4 billion Swiss francs<\/strong> annually. The focus of these investments is on cutting-edge technologies, including <strong>continuous glucose monitoring<\/strong> and manufacturing innovations for <strong>incretin<\/strong> and <strong>amylin<\/strong> peptides. Despite the U.S. focus, Roche continues expanding its presence in other key markets like <strong>China<\/strong>, <strong>Switzerland<\/strong>, and <strong>Germany<\/strong>, emphasizing its global manufacturing strategy.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-verastem-oncology-secures-ind-clearance-for-kras-g12d-inhibitor-trial\"><span class=\"ez-toc-section\" id=\"Verastem_Oncology_Secures_IND_Clearance_for_KRAS_G12D_Inhibitor_Trial\"><\/span>Verastem Oncology Secures IND Clearance for KRAS G12D Inhibitor Trial<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Verastem Oncology <\/strong>has received clearance from the <strong>FDA<\/strong> for its <strong>Investigational New Drug (IND)<\/strong> application for <strong>VS-7375<\/strong>, an oral <strong>KRAS G12D<\/strong> (ON\/OFF) inhibitor. This marks a significant step toward advancing clinical evaluation, with plans to initiate a <strong>Phase I\/IIa trial<\/strong> in <strong>mid-2025<\/strong> for patients with advanced solid tumors, including <a href=\"https:\/\/www.delveinsight.com\/report-store\/pancreatic-cancer-market\"><strong>pancreatic cancer<\/strong><\/a>, <a href=\"https:\/\/www.delveinsight.com\/report-store\/colorectal-cancer-crc-market\"><strong>colorectal cancer<\/strong><\/a>, and <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-cancer-nsclc-market\"><strong>non-small cell lung cancer<\/strong><\/a>. The study will also explore <strong>combination therapies<\/strong> through multiple expansion cohorts.<\/p>\n\n\n\n<p>At the <strong>2025 American Society of Clinical Oncology (ASCO) Annual Meeting<\/strong>, Verastem\u2019s partner <strong>GenFleet Therapeutics<\/strong> will present initial safety and efficacy data from the <strong>VS-7375 Phase I\/II study<\/strong>. The <strong>oral presentation<\/strong> will feature findings from GenFleet&#8217;s initial dose escalation phase, which demonstrated promising results, including partial responses in patients with pancreatic and advanced lung cancers.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe\u2019re excited to advance the clinical program for VS-7375 in the U.S.,\u201d said <\/em><strong><em>Dan Paterson<\/em><\/strong><em>, CEO of Verastem Oncology. \u201cThe early data from GenFleet\u2019s study show strong potential for <\/em><strong><em>VS-7375<\/em><\/strong><em>, and we believe there is a significant opportunity to improve efficacy beyond existing KRAS G12D-selective agents.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The <strong>Phase I\/IIa trial<\/strong> will begin in the U.S., potentially expanding globally, to evaluate the safety and efficacy of <strong>VS-7375<\/strong> in treating <strong>KRAS G12D mutant<\/strong> solid tumors. Initial dosing will be based on prior data from GenFleet\u2019s study, aiming to accelerate the trial&#8217;s progress.<\/p>\n\n\n\n<p><strong>ASCO 2025 Presentation Details:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Title:<\/strong> A First-in-Human Phase I\/II Study of GFH375, a Highly Selective and Potent Oral KRAS G12D Inhibitor in Patients with KRAS G12D Mutant Advanced Solid Tumors<br><\/li>\n\n\n\n<li><strong>Abstract Number:<\/strong> 3013<br><\/li>\n\n\n\n<li><strong>Session Date\/Time:<\/strong> Monday, June 2, 2025, from 8:00 am to 9:30 am CDT (Rapid Oral Abstract Sessions: Developmental Therapeutics\u2014Molecularly Targeted Agents and Tumor Biology)<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-blackfinbio-gets-fda-clearance-for-phase-i-ii-trial-of-bfb-101-in-hereditary-spastic-paraplegia-type-47\"><span class=\"ez-toc-section\" id=\"BlackfinBio_Gets_FDA_Clearance_for_Phase_III_Trial_of_BFB-101_in_Hereditary_Spastic_Paraplegia_Type_47\"><\/span>BlackfinBio Gets FDA Clearance for Phase I\/II Trial of BFB-101 in Hereditary Spastic Paraplegia, Type 47<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>BlackfinBio Ltd has announced that the <strong>FDA has cleared its Investigational New Drug (IND) application<\/strong> for a Phase I\/II clinical trial of <strong>BFB-101<\/strong>, a novel <strong>AAV gene therapy<\/strong> designed to treat <a href=\"https:\/\/www.delveinsight.com\/report-store\/hereditary-spastic-paraplegias-market\"><strong>Hereditary Spastic Paraplegia, Type 47 (SPG47)<\/strong><\/a> \u2014 a rare and debilitating neurological disorder in children. The trial, which will be conducted at <strong>Boston Children\u2019s Hospital<\/strong>, is expected to begin enrolling patients by the end of 2025. The FDA has also granted <strong>Orphan Drug Designation (ODD)<\/strong> and <strong>Rare Pediatric Disease Designation (RPDD)<\/strong> to BFB-101.<\/p>\n\n\n\n<p><strong>SPG47<\/strong> is a progressive genetic disorder caused by mutations in the <strong>AP4B1 gene<\/strong>, leading to spasticity, developmental delays, and intellectual disability. Currently, no approved treatments exist. BFB-101 delivers a functional copy of AP4B1 via an <strong>intracisternal magna (ICM)<\/strong> injection, a delivery method aimed at efficiently targeting the central nervous system. Preclinical studies have shown promising safety and therapeutic potential.<\/p>\n\n\n\n<p>The <strong>Phase I\/II trial<\/strong> will be an open-label study involving up to five pediatric patients with genetically confirmed SPG47. Its primary goal is to evaluate the <strong>safety and tolerability<\/strong> of BFB-101, with secondary endpoints assessing <strong>motor function, development, and quality of life<\/strong> improvements.&nbsp;<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis IND clearance marks a significant step forward in our mission to address rare neurological diseases,\u201d said <\/em><strong><em>Peter Nolan<\/em><\/strong><em>, CEO of BlackfinBio. Lead investigator <\/em><strong><em>Dr. Darius Ebrahimi-Fakhari<\/em><\/strong><em> and CSO <\/em><strong><em>Professor Mimoun Azzouz<\/em><\/strong><em> echoed the urgent need for innovation in treating SPG47, emphasizing the potential of BFB-101 to deliver transformative outcomes for affected children and their families.<\/em><\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>Boston Scientific Pushes Forward Despite $200M Tariff Challenge Boston Scientific has announced that tariffs are expected to add approximately $200 million to its costs this year, but the company remains confident in its ability to absorb the financial hit. Despite the tariff burden, the company reported robust growth across its cardiology and urology divisions, reflecting [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":31570,"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":[137,174,204,704,349,420,6733,1173,20479,18881,20478,449,639,5789,22524],"industry":[17225],"therapeutic_areas":[17240,17228],"class_list":["post-31569","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-cancer","tag-colorectal-cancer","tag-delveinsight","tag-fda","tag-latest-pharma-news","tag-news","tag-non-small-cell-lung-cancer","tag-obesity","tag-obesity-drugs","tag-obesity-market","tag-obesity-pipeline","tag-pancreatic-cancer","tag-pharma-news","tag-recent-pharma-news","tag-tariff","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-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 | Boston Scientific, Roche, Northstrive<\/title>\n<meta name=\"description\" content=\"Boston Scientific Grows Despite Tariffs; Northstrive IND Backed; Roche Counters Tariffs; Verastem IND Cleared; BlackfinBio\u2019s BFB-101\" \/>\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-boston-scientific-roche-northstrive\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Boston Scientific, Roche, Northstrive\" \/>\n<meta property=\"og:description\" content=\"Boston Scientific Grows Despite Tariffs; Northstrive IND Backed; Roche Counters Tariffs; Verastem IND Cleared; 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