Philogen SpA

A total of 256 patients were enrolled across 22 clinical centres in Germany, Italy, France and Poland. Credit: Gorodenkoff / Shutterstock. The European Medicines Agency (EMA) has validated Philogen and Sun Pharmaceutical’s marketing authorisation application (MAA) for Nidlegy, a treatment for melanoma. Nidlegy is an investigational treatment for neoadjuvant (before surgical procedure) locally advanced fully resectable melanoma. The application, submitted on 4 June 2024, is based on data from the Phase III PIVOTAL study and a Phase II trial. The international, multicentre, randomised, comparator-controlled, parallel-group PIVOTAL trial assessed the efficacy and safety of Nidlegy as a neoadjuvant treatment in melanoma patients with locally advanced, fully resectable cutaneous, subcutaneous or nodal metastases accessible to intratumoural injection. A total of 256 patients were enrolled across 22 clinical centres in Italy, Germany, France and Poland. See Also: CAN-3110 by Candel Therapeutics for High-Grade Glioma: Likelihood of Approval ICTCAR-028 by Innovative Cellular Therapeutics for Hematological Tumor: Likelihood of Approval Results from the PIVOTAL trial showed that Nidlegy reduced the relapse or mortality risk by 41% versus the control arm, with a significant improvement in median recurrence-free survival and distant metastasis-free survival (DMFS). Nidlegy’s safety profile was characterised by mostly low-grade, local adverse events. No grade 3 or grade 4 immune-related adverse events or drug-related deaths were recorded. Nidlegy is a biopharmaceutical product of Philogen, designed to treat skin cancer through intralesional administration of two active ingredients, L19IL2 and L19TNF. These ingredients are pro-inflammatory cytokines with potent anti-tumour activity. Nidlegy is also being investigated in additional Phase III trials for locally advanced melanoma and Phase II trials for high-risk basal cell carcinoma and other non-melanoma skin cancers. Philogen CEO and chief scientific officer Dario Neri stated: “The validation of the dossier by the EMA represents the first important milestone for the MAA review process.” “Our group is committed to working with EMA throughout the review process to make Nidlegy available to patients in need.”

Sarclisa is a CD38-directed cytolytic human monoclonal antibody that received its first FDA approval for the treatment of adults with previously multiple myeloma. Credits: nitpicker / Shutterstock. Soon after Sanofi announced that the US Food and Drug Administration (FDA) accepted its supplemental biologics licence application (sBLA) for priority review, the global pharma company announced positive results for the Phase III study of its Sarclisa (isatuximab) combination therapy for the treatment of multiple myeloma (MM). Recommended Buyer's Guides Buyer's Guide Leading Guide to Compliance Software for the Pharmaceutical Industry Buyer's Guide Top Guide for Drug Delivery Systems The results, which were shared at the American Society of Clinical Oncology (ASCO) Annual Meeting, held from 31 May to 4 June, reported that Sarclisa in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) reduced the risk of disease progression or death by 40% compared to treatment with the VRd active comparator arm. The randomised, multi-centre, open-label Phase III IMROZ study (NCT03319667) evaluated the treatment in 446 patients with newly diagnosed, transplant-ineligible MM. The study’s primary endpoint of progression-free survival (PFS) was met, with the estimated PFS at 60 months recorded at 63.2% in the treatment group versus 45.2% in the comparator arm. However, the regimen has not yet reached its trial median PFS. As per the 3 June press release, Sarclisa is the first anti-CD38 combination therapy to “significantly improve” PFS in newly diagnosed transplant-ineligible MM. The key secondary endpoints of IMROZ were complete response rate (CR), minimal residual disease (MRD) negativity rate for patients with a complete response, very good partial response (VGPR) or better rate, and overall survival (OS). Of the patients treated with Sarclisa/VRd, 74.7% achieved a CR and 55.5% achieved an MRD negativity rate, with 46.8% of patients sustaining MRD for at least 12 months. Comparatively, in the VRd active comparator group, 64.1% of patients achieved CR and 40.9% of patients achieved MRD negative CR, with 24.3% of patients sustaining MRD for the same 12-month period. See Also: ASCO 2024: Alligator shares positive data for pancreatic cancer drug Philogen and Sun Pharma seek EMA approval for melanoma therapy Sarclisa demonstrated a consistent safety and tolerability profile, with no new safety signals. Sarclisa, a CD38-directed cytolytic human monoclonal antibody, was first approved as a combination treatment for adults with MM in 2021. According to GlobalData’s consensus forecasts, The therapy is anticipated to generate global sales of $887m in 2030. GlobalData is the parent company of Pharmaceutical Technology . Sanofi’s treatment is set to face stiff competition in the form of J&J’s anti-CD38 treatment, Darzalex (daratumumab), which dominates the market for anti-CD38 MM treatments. As per GlobalData’s consensus forecasts, Darzalex is expected to generate total global sales of $17.5bn in 2029.

The increasing need for radioimmunoassay is mainly driven by the rising occurrence of cancer, infectious diseases, and various other health conditions, along with a growing number of epidemics and pandemics and increasing health awareness. Moreover, the radioimmunoassay market is expected to expand due to numerous ongoing research endeavors in this domain, partnerships between healthcare providers, researchers, and industry stakeholders, as well as strategic collaborations. These factors are poised to enhance the overall growth of the radioimmunoassay market from 2024 to 2030. LAS VEGAS, April 18, 2024 /PRNewswire/ -- DelveInsight's Radioimmunoassay Market Insights report provides the current and forecast market analysis, individual leading radioimmunoassay companies' market shares, challenges, radioimmunoassay market drivers, barriers, trends, and key market radioimmunoassay companies in the market. Key Takeaways from the Radioimmunoassay Market Report As per DelveInsight estimates, North America is anticipated to dominate the global radioimmunoassay market during the forecast period. As per the analysis, the global radioimmunoassay market was valued at USD 523.98 million in 2023. Notable radioimmunoassay companies such as DIAsource, MP BIOMEDICALS, Merck KGaA, Tecan Trading AG, Svar Life Science, Institute of Isotopes Co. Ltd., PerkinElmer Inc., Danaher Corporation, and several others, are currently operating in the radioimmunoassay market. To read more about the latest highlights related to the radioimmunoassay market, get a snapshot of the key highlights entailed in the Global Radioimmunoassay Market Report Radioimmunoassay Overview Radioimmunoassay stands as a groundbreaking technique in the field of medicine and biology, revolutionizing the way researchers detect and measure tiny concentrations of biological substances. Developed in the 1950s by Dr. Rosalyn Yalow and Dr. Solomon Berson, this method uses the specific binding of antibodies to antigens to quantify substances like hormones, enzymes, and drugs. In RIA, a known radioactive substance is added to a sample containing the substance of interest. Then, an antibody that recognizes the substance binds to it, forming a complex. The amount of radioactivity in the complex is directly proportional to the concentration of the substance in the sample, allowing for highly sensitive measurements in the picomolar to nanomolar range. This remarkable precision has made RIA indispensable in diagnosing conditions such as thyroid disorders, diabetes, and various hormonal imbalances. Furthermore, the versatility of Radioimmunoassay extends beyond clinical settings, finding applications in research laboratories worldwide. Scientists rely on RIA to unravel intricate mechanisms of disease progression, monitor drug levels in patients, and investigate the role of hormones in physiological processes. Its ability to detect substances in minute quantities with high accuracy has propelled advancements in fields ranging from pharmacology to endocrinology, shaping our understanding of health and disease at a molecular level. Despite the emergence of newer technologies, the enduring legacy of Radioimmunoassay continues to underpin critical medical discoveries, demonstrating the enduring impact of this pioneering technique in modern science. Radioimmunoassay Market Insights In 2023, North America dominated the radioimmunoassay market, primarily due to several factors. These include a substantial patient population dealing with Sexually Transmitted Diseases (STDs), cancer, and other ailments, a robust environment for product development and launches, and the strong presence of key market players in the region. For instance, in 2019, it was estimated by the Centers for Disease Control and Prevention (CDC) that over 1.1 million people aged 13 and above were living with HIV in the US, while around 1.75 million new cancer cases were reported. Additionally, data from the American Thyroid Association in 2019 suggested that roughly 20 million Americans suffer from some form of thyroid disease, with over 12 percent expected to develop it during their lifetime. Furthermore, the US government's significant investment of USD 650 million in rapid diagnostic testing, as announced by the US Department of Health and Human Services in 2021, further underlines the favorable conditions for the radioimmunoassay market's growth in the region. Consequently, these factors are anticipated to drive the expansion of the radioimmunoassay market in North America throughout the forecast period spanning from 2024 to 2030. To know more about why North America is leading the market growth in the radioimmunoassay market, get a snapshot of the Radioimmunoassay Market Outlook Radioimmunoassay Market Dynamics The radioimmunoassay market dynamics have been steadily evolving, driven by a myriad of factors shaping the healthcare landscape. One of the key drivers is the growing prevalence of chronic diseases such as cancer, cardiovascular disorders, and diabetes. As healthcare providers seek more efficient and accurate diagnostic tools, radioimmunoassay offers a reliable method for measuring minute quantities of substances, including hormones, enzymes, and drugs, in blood samples. This demand for precise diagnostic solutions has propelled the radioimmunoassay market forward, as clinicians rely on these tests for early detection, disease monitoring, and treatment optimization. Moreover, technological advancements have played a pivotal role in the expansion of the radioimmunoassay market. Automation and miniaturization have enhanced the efficiency of RIA tests, reducing turnaround times and improving accuracy. Additionally, the advent of novel biomarkers and reagents has widened the scope of applications for radioimmunoassay, further fueling market growth. With an increasing focus on personalized medicine, there is a rising need for tailored diagnostic approaches, a demand that the versatility and sensitivity of radioimmunoassays are uniquely positioned to fulfill. As such, the radioimmunoassay market continues to demonstrate resilience and promising prospects amidst the evolving landscape of healthcare needs and technological innovation. Get a sneak peek at the radioimmunoassay market dynamics @ Radioimmunoassay Market Dynamics Analysis Radioimmunoassay Market Assessment Radioimmunoassay Market Segmentation Radioimmunoassay Market Segmentation By Product Type: Analyzers And Reagents & Kits Radioimmunoassay Market Segmentation By Application: Research And Clinical Diagnostics Radioimmunoassay Market Segmentation By End User: Hospitals, Clinical Diagnostic Laboratories, Pharmaceutical Industries, and Others Radioimmunoassay Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the radioimmunoassay market are set to emerge as the trendsetter explore @ Radioimmunoassay Companies Table of Contents Interested in knowing the radioimmunoassay market by 2030? 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