Pharma Focus America

Nipocalimab, an investigational monoclonal antibody, has been granted breakthrough therapy designation by the FDA for treating moderate-to-severe Sjögren's disease! This milestone is based on results from the Phase 2 DAHLIAS study, where patients showed over 70% improvement in systemic disease activity at Week 24. With no advanced therapies currently approved for Sjögren’s, this breakthrough offers hope for millions suffering from chronic symptoms like fatigue, dryness, and joint pain. Nipocalimab’s novel mechanism reduces harmful autoantibodies, targeting the root cause of disease activity. This development marks a significant step toward improving patients’ quality of life. 💡 𝐃𝐢𝐬𝐜𝐨𝐯𝐞𝐫 𝐦𝐨𝐫𝐞 𝐚𝐛𝐨𝐮𝐭 𝐭𝐡𝐢𝐬 𝐠𝐚𝐦𝐞-𝐜𝐡𝐚𝐧𝐠𝐢𝐧𝐠 𝐭𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭: https://lnkd.in/gXE-2qG7 #fda #breakthroughtherapy #nipocalimab #sjogrensdisease #healthcareinnovation #clinicaltrials #autoimmunedisease #patientcare #medicalresearch #pharmaceuticals

Introducing the 𝐂𝐓𝐞𝐜𝐡™ 𝐒𝐨𝐥𝐨𝐕𝐏𝐄® 𝐏𝐋𝐔𝐒 𝐒𝐲𝐬𝐭𝐞𝐦—a next-gen tool designed to meet the increasing demands of high-concentration drug formulations. This UV-Vis spectroscopy system ensures accurate results in seconds, enhancing both sensitivity and reproducibility without any dilution! 𝐊𝐞𝐲 𝐛𝐞𝐧𝐞𝐟𝐢𝐭𝐬 𝐢𝐧𝐜𝐥𝐮𝐝𝐞: ◾ Doubling the speed of data collection ◾ Simplified workflows with only two steps ◾ Direct sample measurement with no sample prep required Join the biopharma industry’s shift toward faster decision-making and greater efficiency with Repligen’s cutting-edge technology. 🔗 𝐋𝐞𝐚𝐫𝐧 𝐦𝐨𝐫𝐞 𝐚𝐛𝐨𝐮𝐭 𝐭𝐡𝐞 𝐒𝐨𝐥𝐨𝐕𝐏𝐄 𝐏𝐋𝐔𝐒 𝐚𝐧𝐝 𝐭𝐚𝐤𝐞 𝐲𝐨𝐮𝐫 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐭𝐨 𝐭𝐡𝐞 𝐧𝐞𝐱𝐭 𝐥𝐞𝐯𝐞𝐥!  https://lnkd.in/gBF2Xbp4 #repligen #ctechsolovpeplus #biotechnology #innovation #lifesciences #laboratoryequipment #analyticalchemistry #processdevelopment #pharmaceuticals #researchanddevelopment

𝐉𝐚𝐳𝐳 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬 secures accelerated FDA approval for Ziihera® (zanidatamab-hrii)—the first dual HER2-targeted bispecific antibody therapy for adults with previously treated HER2-positive biliary tract cancer (BTC). This milestone, based on the HERIZON-BTC-01 trial, reported a 52% objective response rate (ORR) and a median duration of response of 14.9 months, addressing a critical unmet need for BTC patients. With BTC's 5-year survival rate at less than 5% in metastatic stages, Ziihera® offers hope for those battling this rare yet aggressive cancer. 𝐋𝐞𝐚𝐫𝐧 𝐡𝐨𝐰 𝐙𝐢𝐢𝐡𝐞𝐫𝐚 𝐢𝐬 𝐭𝐫𝐚𝐧𝐬𝐟𝐨𝐫𝐦𝐢𝐧𝐠 𝐇𝐄𝐑𝟐-𝐩𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐁𝐓𝐂 𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐢𝐭𝐬 𝐨𝐧𝐠𝐨𝐢𝐧𝐠 𝐏𝐡𝐚𝐬𝐞 𝟑 𝐭𝐫𝐢𝐚𝐥𝐬: https://lnkd.in/gpF8fS_P #jazzpharmaceuticals #ziihera #her2positive #biliarytractcancer #cancerresearch #oncologyinnovation #pharmaceuticaldevelopment #healthcareadvancements #clinicaltrials #patientcare

Sartorius' range of ready-to-use 𝐭𝐫𝐚𝐧𝐬𝐟𝐞𝐜𝐭𝐢𝐨𝐧 𝐫𝐞𝐚𝐠𝐞𝐧𝐭𝐬 𝐟𝐨𝐫 𝐥𝐢𝐟𝐞 𝐬𝐜𝐢𝐞𝐧𝐜𝐞 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡 allows scientists to study the function of a protein of interest, its role in a signaling pathway, perform genome editing using plasmid-based or RNA-based proven methods, and conduct cost-effective RNA interference to transfect guide RNA and express Cas9 protein in hard-to-transfect cells. 𝐑𝐞𝐪𝐮𝐞𝐬𝐭 𝐚 𝐟𝐫𝐞𝐞 𝐬𝐚𝐦𝐩𝐥𝐞 𝐚𝐧𝐝 𝐠𝐞𝐭 𝐭𝐡𝐞 𝐦𝐨𝐬𝐭 𝐟𝐫𝐨𝐦 𝐲𝐨𝐮𝐫 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡:  https://lnkd.in/gTkAxNsm #transfectionreagents #lifescienceresearch #samplerequest #biotechnology #researchtools #laboratorysupplies #cellbiology #molecularbiology #scientificresearch #innovationinscience

𝐂𝐚𝐥𝐥𝐢𝐧𝐠 𝐚𝐥𝐥 𝐏𝐡𝐚𝐫𝐦𝐚 𝐄𝐱𝐩𝐞𝐫𝐭𝐬! Do you have groundbreaking insights or innovative thoughts to share with the pharmaceutical world? Here’s your chance to reach a global audience and make a lasting impact. Contribute an article or share your expertise in a Q&A for Pharma Focus America—a leading industry platform! Showcase your knowledge, connect with like-minded professionals, and inspire the future of pharma. 𝐖𝐡𝐲 𝐂𝐨𝐧𝐭𝐫𝐢𝐛𝐮𝐭𝐞? ▪ Reach a global audience and enhance your professional visibility. ▪ Influence the pharma community with your unique perspectives. ▪ Join us in shaping the future of the pharmaceutical industry. We cover key industry topics such as Strategy, Research and Development, Clinical Trials, Manufacturing, BioPharma, and Information Technology 𝗥𝗲𝗮𝗱𝘆 𝘁𝗼 𝘀𝗵𝗮𝗿𝗲 𝘆𝗼𝘂𝗿 𝗲𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲? ▪ Choose a topic from the PFAm Editorial Calendar: https://lnkd.in/gQrqnQRK ▪ Contribute an article and get it published: https://lnkd.in/g_8txkzN 𝐕𝐢𝐬𝐢𝐭 𝐏𝐡𝐚𝐫𝐦𝐚 𝐅𝐨𝐜𝐮𝐬 𝐀𝐦𝐞𝐫𝐢𝐜𝐚: https://lnkd.in/duKnzVCp Don't miss this unique opportunity to be featured in a 𝐥𝐞𝐚𝐝𝐢𝐧𝐠 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐩𝐮𝐛𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧. Together, we can elevate the standards of the pharma community. 📩 Contact Harry at: harry@ochre-media.com 📩 Contact Sarah Richards at: sarah.richards@ochre-media.com #industryinsights #thoughtleadership #professionaldevelopment #knowledgesharing #expertopinions #businesstrends #networkingopportunities #marketanalysis #innovationdiscussion #leadershipthoughts #pharmafocusamerica

𝐑𝐞𝐯𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐢𝐳𝐢𝐧𝐠 𝐑𝐞𝐜𝐨𝐦𝐛𝐢𝐧𝐚𝐧𝐭 𝐏𝐫𝐨𝐭𝐞𝐢𝐧 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐰𝐢𝐭𝐡 𝐂𝐲𝐭𝐢𝐯𝐚™ 𝐏𝐫𝐨𝐭𝐞𝐢𝐧 𝐒𝐞𝐥𝐞𝐜𝐭™ 𝐑𝐞𝐬𝐢𝐧 Are you looking to streamline the process development for recombinant proteins without an affinity-binding partner? 𝐂𝐲𝐭𝐢𝐯𝐚™ 𝐏𝐫𝐨𝐭𝐞𝐢𝐧 𝐒𝐞𝐥𝐞𝐜𝐭™ 𝐫𝐞𝐬𝐢𝐧 is the game changer you've been waiting for! Available in formats designed for both process development and large-scale commercial applications, this resin simplifies the affinity purification protocol, making it faster and more efficient. With new formats released in 𝐉𝐚𝐧𝐮𝐚𝐫𝐲 𝟐𝟎𝟐𝟓, 𝐂𝐲𝐭𝐢𝐯𝐚™ 𝐏𝐫𝐨𝐭𝐞𝐢𝐧 𝐒𝐞𝐥𝐞𝐜𝐭™ 𝐫𝐞𝐬𝐢𝐧 offers a standardized approach to recombinant protein purification. The resin ensures robust scalability and ease of regeneration, bringing you closer to your protein targets in record time! 💡 Ready to take your process development to the next level? Don’t miss our upcoming webinar to explore this technology and its capabilities. 🔗 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐍𝐨𝐰: https://lnkd.in/gnthfPYA #recombinantprotein #processdevelopment #scaleup #cytiva #proteinselect #biotechnology #pharmaceuticals #lifesciences #bioprocessing #proteinpurification

Exciting progress in our 𝐏𝐡𝐚𝐬𝐞 𝟐 𝐭𝐫𝐢𝐚𝐥 𝐟𝐨𝐫 𝐑𝐨𝐩𝐢𝐝𝐨𝐱𝐮𝐫𝐢𝐝𝐢𝐧𝐞, 𝐚 𝐫𝐚𝐝𝐢𝐚𝐭𝐢𝐨𝐧 𝐬𝐞𝐧𝐬𝐢𝐭𝐢𝐳𝐞𝐫 𝐭𝐚𝐫𝐠𝐞𝐭𝐢𝐧𝐠 𝐠𝐥𝐢𝐨𝐛𝐥𝐚𝐬𝐭𝐨𝐦𝐚 𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬. With 25% enrollment completed, we're one step closer to optimizing treatment for the most aggressive brain tumors. Backed by 𝐅𝐃𝐀 𝐎𝐫𝐩𝐡𝐚𝐧 𝐃𝐫𝐮𝐠 𝐃𝐞𝐬𝐢𝐠𝐧𝐚𝐭𝐢𝐨𝐧, we aim to enhance radiation therapy outcomes and improve survival rates. Join us on this journey to redefine cancer care. 💡 𝐋𝐞𝐚𝐫𝐧 𝐦𝐨𝐫𝐞 𝐚𝐛𝐨𝐮𝐭 𝐨𝐮𝐫 𝐠𝐫𝐨𝐮𝐧𝐝𝐛𝐫𝐞𝐚𝐤𝐢𝐧𝐠 𝐭𝐫𝐢𝐚𝐥:  https://lnkd.in/g--j2MWg #glioblastoma #radiationtherapy #oncologyresearch #cancercare #shuttlepharma #clinicaltrials #medicalbreakthrough #braincancer #patientcare #innovationinhealth

Coya Therapeutics, Inc. expands its pipeline with COYA 303, a groundbreaking biologic combining COYA 301 with a GLP-1 receptor agonist. This cutting-edge therapy targets inflammatory diseases by boosting Treg function and reducing inflammation, tackling autoimmune and neurodegenerative conditions. With strategic collaborations and clinical trials on the horizon, Coya is unlocking transformative potential for patients and investors alike. Ready to learn more about the future of immunotherapy? 🔗 𝐃𝐢𝐬𝐜𝐨𝐯𝐞𝐫 𝐂𝐎𝐘𝐀 𝟑𝟎𝟑 𝐡𝐞𝐫𝐞: https://lnkd.in/gFaQfT7e #biotechinnovation #inflammationtherapy #coyatherapeutics #immunology #autoimmune #neurodegeneration #drugdevelopment #clinicaltrials #healthinnovation #biotechinvesting #medicalbreakthroughs #healthcaretransformation

𝐓𝐡𝐞 𝐥𝐚𝐭𝐞𝐬𝐭 𝐞𝐝𝐢𝐭𝐢𝐨𝐧 𝐨𝐟 𝐏𝐡𝐚𝐫𝐦𝐚 𝐅𝐨𝐜𝐮𝐬 𝐀𝐦𝐞𝐫𝐢𝐜𝐚’𝐬 𝐌𝐨𝐧𝐭𝐡𝐥𝐲 𝐄-𝐍𝐞𝐰𝐬𝐥𝐞𝐭𝐭𝐞𝐫 𝐢𝐬 𝐥𝐢𝐯𝐞! Dive into “𝐆𝐞𝐧𝐨𝐦𝐢𝐜 𝐄𝐝𝐢𝐭𝐢𝐧𝐠: 𝐑𝐞𝐯𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐢𝐳𝐢𝐧𝐠 𝐏𝐡𝐚𝐫𝐦𝐚’𝐬 𝐅𝐮𝐭𝐮𝐫𝐞 and explore groundbreaking insights that are shaping the industry: ✔️ Exclusive Articles ✔️ Expert Interviews ✔️ Latest News & Projects ✔️ Press Releases & Tech Trends ✔️ Research Insights & Whitepapers ✔️ Upcoming Events 💡 Want to make your mark in the pharma world? Advertise with us, share your expertise, or join our prestigious Advisory Board. 📩 Don’t miss this opportunity to stay ahead in pharma innovation. Subscribe now! 👉 𝐒𝐮𝐛𝐬𝐜𝐫𝐢𝐛𝐞 𝐇𝐞𝐫𝐞: https://lnkd.in/gpphwDij 🔗𝐒𝐭𝐚𝐲 𝐮𝐩𝐝𝐚𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐨𝐮𝐫 𝐥𝐚𝐭𝐞𝐬𝐭 𝐜𝐨𝐧𝐭𝐞𝐧𝐭 𝐛𝐲 𝐬𝐮𝐛𝐬𝐜𝐫𝐢𝐛𝐢𝐧𝐠 𝐡𝐞𝐫𝐞 https://lnkd.in/gF3cbxXA 🔗𝐄𝐱𝐩𝐥𝐨𝐫𝐞 𝐨𝐮𝐫 𝐌𝐚𝐠𝐚𝐳𝐢𝐧𝐞 𝐈𝐬𝐬𝐮𝐞𝐬: https://lnkd.in/gVSmnx75 🔗𝐈𝐧𝐭𝐞𝐫𝐞𝐬𝐭𝐞𝐝 𝐢𝐧 𝐚𝐝𝐯𝐞𝐫𝐭𝐢𝐬𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐏𝐡𝐚𝐫𝐦𝐚 𝐅𝐨𝐜𝐮𝐬 𝐄𝐮𝐫𝐨𝐩𝐞? 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐨𝐮𝐫 𝐦𝐞𝐝𝐢𝐚 𝐩𝐚𝐜𝐤 𝐡𝐞𝐫𝐞: https://lnkd.in/g2J6tKvi #genomicediting #pharmafuture #healthcareinnovation #biotech #precisionmedicine #researchinsights #techtrends #pharmafocus

𝐇𝐚𝐧𝐬𝐨𝐡 𝐏𝐡𝐚𝐫𝐦𝐚 has received breakthrough therapy designation from China’s National Medical Products Administration (NMPA) for its B7-H3-targeted antibody-drug conjugate (ADC), HS-20093, to treat Extensive-Stage 𝐒𝐦𝐚𝐥𝐥 𝐂𝐞𝐥𝐥 𝐋𝐮𝐧𝐠 𝐂𝐚𝐧𝐜𝐞𝐫 (𝐄𝐒-𝐒𝐂𝐋𝐂). This designation is a major leap in offering new hope for patients whose disease has progressed despite first-line treatments. ES-SCLC is a highly aggressive #cancer with limited treatment options and a dismal 3% five-year survival rate. HS-20093 combines a cutting-edge anti-B7-H3 monoclonal antibody with a topoisomerase inhibitor payload, showing promise in 𝐏𝐡𝐚𝐬𝐞 𝐈𝐈𝐈 𝐭𝐫𝐢𝐚𝐥𝐬 𝐟𝐨𝐫 𝐥𝐮𝐧𝐠 𝐜𝐚𝐧𝐜𝐞𝐫 𝐚𝐧𝐝 𝐏𝐡𝐚𝐬𝐞 𝐈/𝐈𝐈 𝐭𝐫𝐢𝐚𝐥𝐬 𝐟𝐨𝐫 𝐨𝐭𝐡𝐞𝐫 𝐜𝐚𝐧𝐜𝐞𝐫𝐬. Let's celebrate the scientific advancements that are changing the future of cancer treatment! https://lnkd.in/gCFSu8H2 #breakthroughtherapy #smallcelllungcancer #pharmainnovation #cancertreatment #lungcancerresearch #immunotherapy #targetedtherapy #pharmaceuticalindustry #clinicaltrials #oncologyresearch