InviMeds Health

The advent of RGB-10 as a #teriparatide #biosimilar is both exciting and important to the treatment of #osteoporosis for postmenopausal women at very high risk of fracture. This retrospective study adds to the Literature with new evidence from clinical practice of the therapeutic equivallence of #RGB-10 with the reference teriparatide product. Lead by the eminent attention of expert Prof. Dr. Med Peyman Hadji, along with his crew of skilled researchers, the authors followed a group of patients receiving either RGB-10 or a teriparatide reference product and evaluated all patients with all measures. These measures totalled a 2-year time span of comparing endpoint outcomes using the existing assessment methods (i.e. bone mineral density (BMD)) and providing more advanced assessments (i.e. 3D-SHAPER® volumetric and surface BMD, trabecular bone score (TBS), quantitative ultrasound (QUS), and high-resolution peripheral quantitative CT (HRpQCT) of radius and tibia). Impressively, there were no real-world difference between RGB-10 and the reference teriparatied group across all measures at the baseline versus 12 or 24 months, where both groups derived meaningful benefits to their bone health. During the two years of follow-up, the clinical benefit of these therapies shined through for this patient sample with past medical histories of high-risk bone health patients. We identified that there were limitations related to a retrospective single-center design and sample size, nevertheless, in this clinical study, there is real-world evidence to support RGB-10 as a therapeutic equivallent to reference teriparatide product. Most worthy of attention was that the patent on teriparatide recently expired, in doing so, patients may have a next step towards greater access to effective osteoporosis treatments with prosthetic medications. Overall, this study adds to a growing collection of effective, relatively affordable via biosimilar options for the management and treatment of osteoporosis in postmenopausal women at greatest risk of suffering a debilitating fracture. https://lnkd.in/dww5bgxw

The U.S. Food and Drug Administration has recently approved Adaptimmune's groundbreaking gene therapy, Tecelra, marking a significant milestone in the fight against a rare and challenging form of cancer. #Tecelra is a pioneering approach that uses the patient's own immune system to fight synovial sarcoma, a soft tissue cancer that primarily affects young adult males. With an estimated 1,000 new cases diagnosed in the United States each year, this aggressive disease has limited treatment options. Approved through the FDA's accelerated pathway, Tecelra is given as a single intravenous dose to patients who have already tried all other available chemotherapy treatments #HowItWorks? By Extracting the patient's own T-cells, genetically engineering them to recognize and attack the cancer cells, and then reinfusing the modified cells back into the patient's body. FDA through its accelerated approvals has allowed immediate use of Tecelra, it also specifies #Adaptimmune to conduct additional confirmatory trials which will further verify its long-term benefits. With a reported list price of $727,000, the cost of Tecelra underscores the significant investment and scientific breakthroughs required to develop these cutting-edge, personalized therapies https://lnkd.in/gfBrks54

"Enhanced Survival and Quality of Life in Head and Neck Cancer Patients with #Nimotuzumab: A Phase III Study by Tata Memorial Hospital" A study by #TataMemorialHospital in Mumbai has shown that adding nimotuzumab to the standard treatment regimen (radiotherapy and cisplatin) significantly improves survival rates and quality of life for patients with locally advanced squamous cell carcinoma of the head and neck. The study, involving 536 patients from 2012 to 2018, found that the 10-year overall survival rate increased to 33.5% with nimotuzumab, compared to 22.5% with standard treatment alone. Median overall survival also increased from 2.78 years to 3.69 years. Nimotuzumab was well-tolerated with no significant increase in late-term adverse events. This advancement offers a promising new therapeutic option for head and neck cancer patients in India, where such cancers represent a significant portion of the cancer burden https://lnkd.in/gki6J4KD

A study in JAMA Network Open found that for patients with rheumatoid arthritis (RA) who did not respond well to methotrexate, biosimilar drugs were more beneficial and cost-effective than leflunomide. Current guidelines recommend methotrexate monotherapy for RA, but many patients do not respond adequately, leading to the need for additional treatments. High costs have been a barrier to using biological DMARDs, but recent price reductions in Hong Kong for biosimilars may make them more accessible. The study involved 25,099 RA patients and showed that treatment with biosimilar DMARDs was cheaper and resulted in higher quality-adjusted life-years (QALYs) compared to leflunomide. The findings suggest that biosimilar DMARDs may be a more cost-effective option for RA patients who do not respond well to methotrexate. https://lnkd.in/eTe-73P4

Exciting news in the world of #biosimilars! The European Commission has approved four new biosimilars, including Celltrion's Omlyclo (#omalizumab), Sandoz's #denosumab biosimilars Jubbonti and Wyost, and Samsung Bioepis' Pyzchiva (#ustekinumab). Additionally, Samsung Bioepis' Epysqli (#eculizumab) has received an expanded indication for the treatment of atypical hemolytic uremic syndrome (aHUS). These approvals bring new treatment options for patients with a range of conditions, including asthma, osteoporosis, and inflammatory diseases. https://lnkd.in/gXbA7mjR

FDA-approved biosimilars are safe, effective, and highly similar to their reference products, with no clinically meaningful differences in safety or potency. Interchangeable biosimilars can be substituted at pharmacies without prescriber intervention, increasing patient access and lowering costs. Derived from living cells, biosimilars are administered similarly to their reference products and offer the same treatment effectiveness. Despite misconceptions, both biosimilars and interchangeable biosimilars are equally reliable for healthcare professionals. Since their first approval in 2015, biosimilars have significantly impacted public health, improving outcomes and accessibility. Explore the FDA’s Purple Book Database for approved biosimilars and learn more on the FDA’s Biosimilars page. #Biosimilars #Healthcare #FDA #MedicalInnovation #PatientCare

The FDA is excited to announce the Digitally-Derived Endpoints for Freezing-of-Gait Detection (DEFoGD) Challenge! This initiative, led by the Center for Devices and Radiological Health and the Office of Digital Transformation, aims to develop advanced AI/ML models for predicting freezing-of-gait (FoG) in Parkinson's Disease (PD) patients. Participants will develop AI models using existing datasets and validate their performance against an internal FDA dataset. This challenge supports the FDA's Technology Modernization Action Plan (TMAP) and Data Modernization Action Plan (DMAP), aiming to enhance health equity and improve outcomes through technological innovation. Important Dates: Start Date: May 28 End Date: August 2 Learn more about the challenge and participate by visiting the link. Follow InviMeds Health for more updates on healthcare. #ParkinsonsDisease #DigitalHealth #AI #MachineLearning #InviMedsHealth #HealthcareInnovation #FDAChallenge #DEFoGD

The FDA has approved #IQIRVO (#elafibranor) tablets for treating primary biliary cholangitis (#PBC) in adult patients. This marks a significant advancement in the management of this rare autoimmune disease, providing new hope for those who have an inadequate response to or cannot tolerate ursodeoxycholic acid (UDCA). IQIRVO, a peroxisome proliferator-activated receptor (PPAR) agonist, is now available as an option either in combination with UDCA or as monotherapy. This approval is based on the demonstrated reduction in alkaline phosphatase (ALP) levels, although further confirmatory trials are needed to verify clinical benefits. Key considerations include: Recommended dosage: 80 mg orally once daily. Precautions: Assess for muscle pain or myopathy, and verify females of reproductive potential are not pregnant before starting treatment. Monitor for adverse reactions, including myalgia, fractures, and liver injury. Please refer to the full prescribing information for more detailed information on this groundbreaking approval. Stay informed with #InviMeds Health for the latest in healthcare innovations and advancements.

Unlock the potential of #pharmaceutical #sourcing with Italy's regulatory framework and Invimeds. Discover the procurement of high-quality Reference Listed Drugs (#RLDs) and #biologics while navigating Italy's robust regulatory landscape. Elevate your pharmaceutical supply chain and ensure reliability with Invimeds, facilitating seamless sourcing of RLDs from Italy while adhering to stringent regulatory standards. Follow Invimeds for more insights and explore how we can optimize your pharmaceutical sourcing process. #PharmaceuticalSourcing #RLDSourcing #RegulatoryFramework #InviMedsHealth #PharmaceuticalSupplyChain #QualityAssurance #LogisticsExcellence https://bit.ly/3XcaDnt

The CDSCO panel has approved the continuation of Phase II clinical trials for Serum Institute of India's (SII) tetravalent live attenuated dengue vaccine. Phase I trials, conducted on 60 healthy individuals aged 18-45 in Australia, demonstrated promising safety and immunogenicity results. This approval allows further evaluation of the vaccine's safety and efficacy in the Phase II trial, marking a significant step forward in dengue prevention. Click the link to read the whole article and follow InviMeds Health for more updates. https://lnkd.in/guSTxtY3 #DengueVaccine #ClinicalTrials #InviMedsHealth