MedicoInsights’ Post

𝐁𝐨𝐞𝐡𝐫𝐢𝐧𝐠𝐞𝐫 𝐈𝐧𝐠𝐞𝐥𝐡𝐞𝐢𝐦 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐢𝐧 𝐏𝐡𝐚𝐬𝐞 𝐈𝐈𝐈 𝐅𝐈𝐁𝐑𝐎𝐍𝐄𝐄𝐑™-𝐈𝐏𝐅 𝐓𝐫𝐢𝐚𝐥 Boehringer Ingelheim’s Boehringer Ingelheim FIBRONEER™-IPF trial met its primary endpoint, demonstrating a significant improvement in lung function (Forced Vital Capacity [mL]) at week 52 compared to placebo. This milestone supports plans to submit a new drug application for nerandomilast, an investigational oral PDE4B inhibitor, to the FDA and other regulatory authorities globally. This marks the first successful IPF phase III trial in a decade, reflecting the company's continued commitment to addressing the unmet needs of patients with idiopathic pulmonary fibrosis (IPF). The FIBRONEER™ global program includes studies in both IPF and Progressive Pulmonary Fibrosis (PPF), involving over 1,100 patients across 30+ countries. #IPF #LungHealth #Fibrosis #ClinicalTrials #BoehringerIngelheim #PharmaInnovation

📰 REGULATORY UPDATE: The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of a Type II extension of indication for amivantamab (Rybrevant) in combination with carboplatin and pemetrexed chemotherapy, according to an announcement from Janssen-cilag International Nv, a Johnson & Johnson company. The recommended extension of indication for the treatment for adults with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after patients experience failure of prior therapy, including an EGFR tyrosine kinase inhibitor. ➡ Learn more: https://lnkd.in/gMXpn8Gv #lcsm #NSCLC

🎬 Less is more Today, the Oncologic Drugs Advisory Committee unanimously voted for the FDA to change its requirements for perioperative trial designs. The trial designs should assess the contribution of each phase (#adjuvant and #neoadjuvant) separately. The current two-arm trial design, which examines both neoadjuvant and adjuvant therapies simultaneously, is unacceptable and leads to overtreatment as well as unnecessary clinical and financial toxicity. See the proposed multi-arm trials in the slides below. Check all approvals in early setting on the website of Timothée Olivier: https://lnkd.in/gRe46pRu Thanks Timothée for keeping track of all these trials. 🍀 Perhaps the most inspiring studies for me in the early setting have been CheckMate 816 of Bristol Myers Squibb and NICHE-2 of Myriam Chalabi The slides below were presented by Erin Larkins & Bernardo Haddock Lobo Goulart. Watch the whole meeting here: https://lnkd.in/gD9ziRgT #odac

A look back at the MGCD Archive Did you know... In 1983, MGC Diagnostics played a key role in evaluating the effectiveness of a new pharmaceutical drug. We assisted an international firm in assessing the drug's ability to prevent certain forms of heart disease. This project exemplifies our ongoing commitment to innovation in cardiorespiratory diagnostics. We're proud to be a part of advancements that improve patient care and heart health! Want to learn more about our history of innovation in cardiovascular health? Visit https://lnkd.in/g5ha7pwZ to discover how MGC Diagnostics continues to shape the future of medical diagnostics. #cardiovascularhealth #pharmaceuticalresearch #diagnostics #historyofmedicine #respiratory #pulmonary #lunghealth

The next 90 days could be most transformative for Medexus will a pending decision by the FDA (end of Jan, 2025) on the transformative drug Treosulfan, and a pending Health Canada decision (Fiscal Q1 2025) on Topical Terbinafine. These should be the most exciting of times for Medexus Shareholders. (MDP:TSX)

Breaking ground in EGPA treatment, the MANDARA Phase III trial outcomes are a beacon of hope🌟 Navigating the challenging terrain of eosinophilic granulomatosis with polyangiitis (EGPA) has been fraught with the adverse effects of long-term oral corticosteroid (OCS) use. Until now. The New England Journal of Medicine just shone a light on the MANDARA trial, showcasing FASENRA® (benralizumab) as a promising dawn in disease remission 📰💉 This landmark trial, pitted two biologics head-to-head, revealing that over half the EGPA warriors could reclaim their lives from OCS dependency, courtesy of eosinophil-targeting biologic therapies. FASENRA emerged on par with its counterpart mepolizumab, with a non-inferior remission rate and a glimmer of hope for fully phasing out steroids. 59% of patients reached remission defined by the BVAS scale plus low OCS doses, and 41% managed to cease OCS usage - a significant stride ahead of mepolizumab's 26%. Such findings are a testament to the trial's success and a nod to the relentless quest for refining EGPA management🔍👩⚕️ With eosinophils at the heart of EGPA's storm, addressing their role is pivotal. And FASENRA has proven it can do just that, offering a brighter future where remission isn't just a dream, but an attainable reality ✅✨ #EGPA #ClinicalTrials #InnovationInHealthcare #FASENRA #MANDARA #Biotechnology #Pharmaceuticals #ClinicalTrials #ClinicalResearch #LifeScience #ElixirAssociates #StaffingPartner

OBEFAZIMOD, A FIRST-IN-CLASS DRUG FOR THE TREATMENT OF ULCERATIVE COLITIS   Abivax Reports: Positive Interim Efficacy and Safety Analysis of Once-Daily 25mg Obefazimod in Moderate to Severe Ulcerative Colitis Patients After 2-Years of Open-Label Maintenance. Obefazimod (ABX464), Abivax’s lead investigational drug candidate, is an orally available small molecule with anti-inflammatory properties through the specific and selective upregulation of miR-124 expression. Phase 2 clinical trials in patients with UC have generated positive data, resulting in the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. Initiation of a Phase 2b clinical trial in Crohn’s disease is expected in Q4 2024, and exploration of potential combination therapy opportunities in UC is ongoing. #Obefazimod #ABX464 #UlcerativeColitis   https://lnkd.in/d-MTMJD7

Ionis and Arrowhead in the race to reduce triglycerides... Arrowhead released the details from their Phase 3 PALISADE trial of plozasiran (siRNA), for familial chylomicronemia syndrome (FCS), showing an 83% reduction in acute pancreatitis events compared to placebo. This is in competition with Ionis' olezarsen (an ASO). Ionis previously showed 100% reduction in pancreatitis events but there are differences in trial design and patient history. Both compounds target apoC to try to reduce triglycerides. Different doses, different chemistries, but same target. Ionis filed the NDA for olezarsen earlier this year and Arrowhead will follow shortly planning to file an NDA before end of year. Lots of novel therapies moving into broader and broader indications. #pharma #genetherapy #raredisease

𝗣𝗹𝗶𝗮𝗻𝘁 𝘁𝗼𝘂𝘁𝘀 𝗮𝗱𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹 𝗣𝗵𝗮𝘀𝗲 𝟮𝗮 𝗱𝗮𝘁𝗮 𝗳𝗼𝗿 𝗼𝗿𝗮𝗹 𝗜𝗣𝗙 𝗱𝗿𝘂𝗴 𝘁𝗵𝗮𝘁’𝘀 𝗮𝗹𝗿𝗲𝗮𝗱𝘆 𝗶𝗻 𝗮 𝗽𝗶𝘃𝗼𝘁𝗮𝗹 𝘀𝘁𝘂𝗱𝘆 Pliant Therapeutics unveiled more efficacy data from a small mid-stage trial of its lead candidate in idiopathic pulmonary fibrosis, which shows that its oral drug could potentially reverse fibrosis. The Phase 2a trial had a primary endpoint of change in type 1 collagen in the lung, as measured by standardized uptake value (SUV) of a certain radiotracer that binds to this form of collagen. In 10 evaluated patients, bexotegrast led to a mean 0.015 reduction from baseline in the top quartile SUV, versus a mean 0.074 increase for placebo, according to a company release. Bernard Coulie, Pliant Therapeutics CEO https://lnkd.in/eFz2JTrS

Your Weekly Dose of Biosimilar News:💉 * Dr. Niazi is here to break down interchangeability like Thanos explaining the Infinity Stones * Tyenne's the new tocilizumab biosimilar on the block, but don't worry, it's been approved by the FDA * Alvotech's got another biosimilar approved, making them a biosimilar boss like Beyonce * Julie Reed is giving us a biosimilar industry forecast - get ready for major policy shifts and hopefully more people switching to biosimilars * The AON is saving major $$ with biosimilars - that's more money for epic patient care https://lnkd.in/e_KR7hhk