Celltelligence’s Post

𝐂𝐞𝐥𝐥𝐭𝐫𝐢𝐨𝐧 𝐔𝐒𝐀 𝐒𝐮𝐛𝐦𝐢𝐭𝐬 𝐁𝐋𝐀 𝐟𝐨𝐫 𝐂𝐓-𝐏𝟒𝟕: 𝐀 𝐍𝐞𝐰 𝐄𝐫𝐚 𝐢𝐧 𝐑𝐡𝐞𝐮𝐦𝐚𝐭𝐨𝐢𝐝 𝐀𝐫𝐭𝐡𝐫𝐢𝐭𝐢𝐬 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 📄 Celltrion USA Celltrion USA has submitted the Biologics License Application (BLA) for CT-P47, a biosimilar candidate of ACTEMRA® (tocilizumab), to the U.S. FDA. 💊 CT-P47, containing tocilizumab, aims to provide a more accessible treatment option for rheumatoid arthritis. The submission is based on positive Phase III trial results, evaluating efficacy, safety, and more. 👥 Thomas Nusbickel Tom Nusbickel, Chief Commercial Officer at Celltrion USA, emphasizes the importance of this step in offering patients a diverse product lineup in the autoimmune disease market. 📆 Stay tuned as Celltrion actively cooperates with the FDA for a potential new treatment option for rheumatoid arthritis. #HealthcareInnovation #Biotech #FDASubmission #RheumatoidArthritis #BioPharma #MedicalAdvancements #CTP47 #ACTEMRA #CelltrionUSA #ClinicalTrials

Cystic fibrosis (CF) creates serious obstacles for patients, impacting their lungs and digestive systems. In a major breakthrough, NHS England has finalized a long-term deal with Vertex Pharmaceuticals, guaranteeing ongoing access to critical CF medicines like Kaftrio, Symkevi, and Orkambi for both children and adults. This agreement resolves a lengthy cost dispute with NICE, highlighting the transformative benefits of these treatments for patients. Explore over 5,000 agreements in Lyfegen’s comprehensive Agreements Library, the largest global resource of its kind: https://lnkd.in/euuJz8sC #HealthcareInnovation #CysticFibrosis #Pharmaceuticals #NHS #PatientOutcomes #AgreementsLibrary

With 45 Radiopharmaceutical trials (the majority in Oncology) and over 10 years of experience in the Radio space, Aixial is your resource for the unique challenges faced with these complex projects. Jim Lincoln is ready to answer all of your burning questions about Radiopharmaceutical trials. If you're in San Francisco, come check out his talk at COG next week! And be sure to visit Shawn Cozad and me at Booth#30. Otherwise, send me a message and I'll be glad to send you some information! #OncologyCRO #Radiopharmaceuticals #MidsizeCRO #OncologyClinicalResearch

An FDA advisory committee recommends against PD-1 inhibitors as first-line treatment for ESCC patients with low/negative PD-L1 expression. This represents a clear policy shift from the FDA, moving away from broader approvals towards more targeted indications based on biomarker status. Drug developers should anticipate this trend and plan their clinical development and regulatory strategies accordingly, focusing on identifying and validating predictive biomarkers that can guide patient selection and optimize treatment outcomes. Find out more from my colleagues Sinan Sarac and Gwyn Bebb in our latest Regulatory Navigator blog. #CancerResearch #Immunotherapy #clinicaltrials #WithHeart

Final FDA guidance for Oligonucleotide drug development recommends QT prolongation risk assessment, immunogenicity assay development and evaluation of hepatic & renal impaired patients. FDA guidance: https://lnkd.in/g2EmpR8p Read our blog: https://lnkd.in/egviY3vA #RNA #OligonucleotideTherapies #ClinicalDrugDevelopment

Reblozyl Receives EC Nod for First-Line Anemia Treatment of in Lower-Risk Myelodysplastic Syndromes The European Commission has granted extended approval for Bristol Myers Squibb's Reblozyl as a first-line therapy for transfusion-dependent anemia in adults with lower-risk Myelodysplastic Syndromes (LR-MDS). The approval is based on the results of the COMMANDS study, which showed that Reblozyl is more effective than the standard treatment, epoetin alfa, in achieving transfusion independence and increasing hemoglobin levels in LR-MDS patients. The approval is seen as a significant advancement in anemia management and offers new hope for MDS patients. Reblozyl's novel mechanism of action promotes the expansion and maturation of late-stage red blood cells, making it a groundbreaking therapeutic option for anemia associated with LR-MDS and beta-thalassemia. This is the fourth approval for Reblozyl in Europe, expanding its indications for various conditions. For more details please click the link! https://lnkd.in/dKUB9uPa #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Choosing predictive and clinically relevant endpoints is a key aspect of drug development in the regulatory space. By assessing orphan drug development for sickle cell disease (SCD) over the past two decades, we observed that failures in clinical development were mainly found in phase 3 due to lack of efficacy on vaso-occlusive crises as the primary study endpoint. This was likely related to variable definitions and heterogeneity of pain scoring and treatment. If you are interested in improving the debate on how fostering pharmaceutical R&D on SCD (and other rare diseases), you may wish to read our last work on this. https://lnkd.in/difgpBep #sicklecell #orphandrugs

Final FDA guidance for Oligonucleotide drug development recommends QT prolongation risk assessment, immunogenicity assay development, and evaluation of hepatic & renal impaired patients. FDA guidance: https://lnkd.in/g2EmpR8p Read our blog: https://lnkd.in/egviY3vA #RNA #OligonucleotideTherapies #ClinicalDrugDevelopment

Thoughts on this? >> FDA grants full approval to Travere’s Filspari for IgAN  >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #productmarketing #biotech #pharma #healthcare