Engimmune Therapeutics’ Post

🚨 FDA Approves SARCLISA as First-Line Treatment for Multiple Myeloma 🚨 At Lampgen Clinical Research, we are committed to supporting breakthrough oncology treatments by staffing Clinical Research Associates (CRAs) who are experienced and exceptional. The recent FDA approval of SARCLISA (isatuximab-irfc) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment for newly diagnosed multiple myeloma (NDMM) patients not eligible for transplant is a major milestone. This approval, backed by the IMROZ Phase 3 study, demonstrates significant improvements in progression-free survival (PFS), reducing the risk of disease progression or death by 40% in comparison to VRd alone. These results offer renewed hope for older and more vulnerable patients, a critical demographic in the fight against multiple myeloma. As oncology trials become more complex, having experienced CRAs who understand the intricacies of these innovative therapies is more important than ever. At Lampgen, we streamline the CRA recruitment process to ensure you have access to top-tier talent capable of driving your oncology studies to success. With oncology research evolving rapidly, Lampgen Clinical Research remains dedicated to supporting sponsors and CROs in delivering the best possible outcomes for patients. #OncologyResearch #MultipleMyeloma #CRAStaffing #ClinicalTrials #SARCLISA #FDAApproval #CancerResearch #LampgenClinicalResearch #PatientSafety #OncologyInnovation https://lnkd.in/eGeBqx6J

𝗜𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀: 𝗛𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 Here are three briefly summarised articles to help keep you informed of the latest developments in the industry. 𝗡𝗼𝘃𝗼 𝗡𝗼𝗿𝗱𝗶𝘀𝗸 𝗮𝗻𝗻𝗼𝘂𝗻𝗰𝗲𝘀 𝟰.𝟭 𝗯𝗶𝗹𝗹𝗶𝗼𝗻 𝗨𝗦𝗗 𝗶𝗻𝘃𝗲𝘀𝘁𝗺𝗲𝗻𝘁 𝘁𝗼 𝗲𝘅𝗽𝗮𝗻𝗱 𝗨𝗦 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝗰𝗮𝗽𝗮𝗰𝗶𝘁𝘆 #NovoNordisk has announced a $4.1 billion investment to construct a second fill and finishing manufacturing facility in Clayton, North Carolina. This facility will focus on procuring current and future injectable treatments for people with #obesity and other serious chronic diseases. The new facility will add 1.4 million square feet of production space, doubling the combined square footage of all three of the company’s facilities in North Carolina. This announcement follows closely on the heels of #Eli Lilly’s recent announcement it will invest USD $5.3 billion to increase its manufacturing capacity. Read more here: https://lnkd.in/g-SG4EHy Read about Lilly's announcement here: https://lnkd.in/gQGYhM7s 𝗩𝗲𝗿𝗼𝗻𝗮 𝗣𝗵𝗮𝗿𝗺𝗮 𝗮𝗻𝗻𝗼𝘂𝗻𝗰𝗲𝘀 𝗨𝗦 𝗙𝗗𝗔 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗼𝗳 𝗢𝗵𝘁𝘂𝘃𝗮𝘃𝗿𝗲™ (𝗲𝗻𝘀𝗶𝗳𝗲𝗻𝘁𝗿𝗶𝗻𝗲) The US Food and Drug Administration (#FDA) has approved #Ohtuvayre for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. This is the first novel treatment in more than a decade for #COPD. Ohtuvavre is a selective dual inhibitor of the phosphodiesterase 3 and phosphodiesterase 4 enzymes, approved as an add-on to current therapies. The FDA’s decision was based on the Phase 3 #ENHANCE trial, which demonstrated clinical benefit both as monotherapy and with other maintenance therapies. Ohtuvayre is expected to be available in the third quarter 2024. Read more here: https://lnkd.in/ghTwtXCw 𝗔𝗺𝗲𝗿𝗶𝗰𝗮𝗻 𝗖𝗮𝗻𝗰𝗲𝗿 𝗦𝗼𝗰𝗶𝗲𝘁𝘆 𝗮𝗻𝗱 𝗔𝗺𝗲𝗿𝗶𝗰𝗮𝗻 𝗦𝗼𝗰𝗶𝗲𝘁𝘆 𝗼𝗳 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝘁𝗼 𝗰𝗿𝗲𝗮𝘁𝗲 𝗼𝗻𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗹𝗮𝗿𝗴𝗲𝘀𝘁 𝗮𝗻𝗱 𝗺𝗼𝘀𝘁 𝗰𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝗼𝗻𝗹𝗶𝗻𝗲 𝘀𝗼𝘂𝗿𝗰𝗲𝘀 𝗼𝗳 𝗰𝗿𝗲𝗱𝗶𝗯𝗹𝗲 𝗰𝗮𝗻𝗰𝗲𝗿 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 The American Cancer Society (#ACS) and the American Society of Clinical Oncology (#ASCO) have announced a collaboration to streamline access to authoritative cancer sites, cancer.org and cancer.net, to cover the entire cancer continuum from prevention to survivorship. The goal is to ensure that individuals affected by cancer can easily find and access high-quality information. This information can now all be found on cancer.org. Read more here: https://lnkd.in/gkwCDu-p

Takeda has sealed a major $2.2 billion agreement with AC Immune to enhance and market AC Immune's Alzheimer’s vaccine candidate, ACI-24.060, now in early-stage clinical trials. The collaboration involves an upfront payment of $100 million to AC Immune, with additional milestone payments that could reach $2.1 billion, plus sales royalties. This substantial deal reflects confidence in the promising future of #Alzheimer's treatment and positions Takeda as a key player in pioneering treatments for this challenging disease. The substantial investment and the strategic nature of the partnership signal strong confidence in the potential of immunotherapy in Alzheimer’s disease, reflecting a growing trend of large-scale investments in neurodegenerative disease research. #leamanlifesciences https://lnkd.in/dbNmfdi6

Gilead Sciences has announced a strategic expansion of its liver disease portfolio through the acquisition of CymaBay Therapeutics at a valuation of $4.3 billion. This acquisition is centered around the PBC medication seladelpar, a treatment that could revolutionize the quality of life for patients with this rare condition. Seladelpar has shown promise not only in clinical trials but also in receiving a priority review nod from the FDA, with a much-anticipated decision expected by August 14. The importance of this treatment cannot be overstated; PBC leads to the destructive accumulation of bile acids, resulting in potentially dangerous enzyme elevations in the liver. The integration of seladelpar into Gilead's existing suite of liver disease treatments could signify a major leap forward in addressing a niche yet urgent medical need. Daniel O'Day, CEO of Gilead Sciences, has expressed a strong commitment to driving seladelpar forward, building upon CymaBay's impressive R&D groundwork. Leveraging Gilead's expertise in liver diseases, O'Day envisions that this acquisition not only fills an existing gap in treatment options but also reinforces the company's dedication to delivering transformative therapies across a range of conditions. Gilead's initiative is set to potentially alter the landscape of PBC management, offering patients renewed optimism for the future 🌐🧬🔬. #LiverHealth #PharmaMergers #InnovationInTreatment #Gilead #CymaBayTherapeutics

AstraZeneca and Alexion Pharmaceuticals, Inc. are set to present at the International Symposium on Amyloidosis (ISA) 2024, focusing on their amyloidosis treatment pipeline. Key findings will include subgroup analyses from the NEURO-TTRansform study of WAINUATM for hereditary transthyretin-mediated amyloidosis. FDA-approved WAINUATM has shown efficacy in treating the polyneuropathy associated with this condition. Clinical data on ALXN2220 and anselamimab, in Phase III trials for ATTR and light chain (AL) amyloidosis, will be highlighted. AstraZeneca and Alexion's commitment to advancing amyloidosis research and patient outcomes will be underscored during the symposium. Further presentations will cover live-cell imaging and Phase I data on ALXN2220’s potential in removing cardiac amyloid, supporting its use in advanced ATTR cardiomyopathy. The need for improved diagnosis and treatment options in AL amyloidosis will be emphasized, along with insights from AstraZeneca’s evidence program on patient characteristics and treatment effectiveness. Notably, WAINUA is being evaluated in the CARDIO-TTRANSform study for adults with ATTR-CM, the largest Phase 3 study in this patient population with over 1,400 participants. For more details, click on the link: https://lnkd.in/gQT-NJXf Daniel Grice Jill Bell

📢 FDA Approves Sanofi's Sarclisa in Newly Diagnosed Multiple Myeloma ➤ Sarclisa (isatuximab) with bortezomib, lenalidomide, and dexamethasone approved for NDMM adults who are not eligible for autologous stem cell transplant ➤ Efficacy was evaluated in IMROZ (NCT03319667), an open-label, randomized, active-controlled phase 3 trial. Enrollment was limited to patients 80 years of age and younger. A total of 446 patients were randomized (3:2) to receive Isa-VRd or VRd ➤ IMROZ demonstrated an improvement in PFS in the Isa-VRd arm with a 40% reduction in risk of disease progression or death (hazard ratio 0.60 [95% CI: 0.44, 0.81]; p-value 0.0009); the median PFS was not reached (NR) (95% CI: NR, NR) in the Isa-VRd arm and was 54.3 months (95% CI: 45.2, NR) in the VRd arm ➤ The most common adverse reactions (≥20%) were upper respiratory tract infection, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia, and COVID-19 infection https://lnkd.in/eNUSh6JW #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent

FDA's Project Optimus: Revolutionizing Cancer Treatment Dosage #fda Dive into the groundbreaking initiative launched by the US Food and Drug Administration on February 14th, 2023 - Project Optimus. Led by the FDA's Oncology Center of Excellence (OCE), this project aims to revolutionize the approach to determining the optimal dosage of medicine for cancer treatment. Learn how the current process often results in using doses that are not well-studied, leading to unnecessary side effects for patients. Discover how Project Optimus seeks to address this issue by improving dose selection, allowing patients to benefit from new medicines for longer periods while minimizing adverse effects. Join us as we explore the potential of this innovative approach to transform cancer treatment outcomes. #ProjectOptimus #FDAInitiative #CancerTreatment #OncologyResearch #MedicationDosage #PrecisionMedicine #TreatmentOptimization #FDAOncology #CancerTherapy #MedicalInnovation #DrugDevelopment #HealthcareImprovement #PatientOutcomes #MedicationSafety #ClinicalTrials #PrecisionOncology #MedicalResearch #CancerAwareness #TreatmentEffectiveness #HealthcareProgress #DrugDosage #MedicalAdvancements #PatientCare #TreatmentEfficacy #CancerResearch #HealthcareInnovation #OncologyCare #DrugSafety #HealthcareDevelopment #MedicalBreakthroughs #CancerSupport #FDAUpdates #HealthTech #OncologyTreatment #MedicalScience #ClinicalResearch #PatientBenefits #PrecisionTherapy #TreatmentSuccess #HealthcareTransformation #OncologyAdvancements #DrugRegulation #PatientWellness #HealthcareImprovements #CancerInnovation #FDAApproval #MedicalGuidelines #CancerResearch #PrecisionOncology #TreatmentDevelopment #MedicalAdvancement #PatientCareImprovement #HealthcareInnovation #OncologyProgress #DrugDosageOptimization #ClinicalTrialsAdvancement #MedicalScience #CancerTherapyEnhancement #FDARegulation #HealthcarePolicy #OncologyTreatment #MedicationSafety #PrecisionMedicineApproach #DrugDevelopmentImprovement #PatientOutcomesEnhancement #HealthcareEfficiency #CancerTreatmentAdvancements #MedicationEfficacy #ClinicalResearchProgress #OncologyCareImprovement #DrugDosagePrecision #FDAInitiatives #HealthcareReform #PrecisionTreatmentApproach #PatientWellbeing #CancerAwarenessCampaign #MedicalBreakthroughs #HealthcareTechnology #DrugSafetyEnhancement #TreatmentEffectivenessImprovement #PrecisionMedication #HealthcareLeadership #CancerTreatmentInnovation #OncologyResearchAdvancements #DrugDosageResearch #PatientHealthImprovement #HealthcareTransformation #CancerCareEnhancement #MedicalInnovationInitiatives #TreatmentEfficacyResearch #PrecisionMedicineDevelopment #HealthcareQualityImprovement #OncologyDrugDiscovery #MedicalGuidelinesRevision #PatientOutcomeOptimization #HealthcareDevelopmentInitiatives

Subcutaneous Injection Approved for Atezolizumab and Hyaluronidase: FDA Expands Treatment Options The FDA has approved a new subcutaneous formulation of atezolizumab and hyaluronidase (Tecentriq Hybreza by Genentech) for adult patients with multiple cancers, including NSCLC, SCLC, HCC, melanoma, and ASPS. Clinical trials, such as IMscin001, demonstrated that this subcutaneous option offers comparable efficacy and safety to the intravenous version, with similar outcomes in overall response rate, progression-free survival, and overall survival. The new formulation allows for quicker administration, improving convenience for long-term cancer treatment. Common side effects were consistent with the IV version. For more details please click the link! https://lnkd.in/d3dz5fB9 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Our health service is committed to giving patients access to new medicines. The HSE has a robust assessment in place for approving medicines, with decisions based on several factors including clinical need, efficacy and effectiveness. The newly approved abemaciclib will have a significant impact for many women diagnosed with breast cancer in Ireland each year, by reducing the risk of recurrence in those most at risk by 30%. This is just one of many medicines approved by the HSE so far this year. Other approved medicines include those for several types of cancer, antimicrobial infections and post-menopausal osteoporosis. These medicines are available under the Community Drugs Schemes and other arrangements, ensuring equitable access for those whose treatment requires them. New medicines that are approved can have a profound and life-enhancing impact for those who need them. We will continue to support people to live healthier, happier lives in the future. https://lnkd.in/ekjJHUYZ