DIA’s Post

𝗣𝗮𝗻𝗲𝗹 𝗗𝗶𝘀𝗰𝘂𝘀𝘀𝗶𝗼𝗻: 𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 𝗙𝗼𝗿 𝗜𝗻𝗳𝗮𝗻𝘁 𝗠𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗺𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 Up next at 13:30, we will be welcoming the following speakers to the stage: • Nikole Kimes, Founder & CEO, Siolta Therapeutics • Ellen Turner, MD, FIDSA, Medical Officer, FDA Center for Biologics Evaluation and Research/Division of Vaccines and Related Products Applications • Dr. Amine ZORGANI, Founder, The Microbiome Mavericks This panel discusses the regulatory adjustments to infant clinical trials and the importance for the microbiome industry to include this underserved patient population. #MicrobiomeConnect #MicrobiomeConnectUSA #MicrobiomeConnectSeries

#ACROHighlights [Featured Product] Companion diagnostics can evaluate important information such as the safety and effectiveness of corresponding drugs or biological products. Accurate screening of patients participating in clinical trials through reliable Claudin 18.2 companion diagnostic methods can effectively improve the success rate of Claudin 18.2 drug clinical trials. For CDx with the drug development targeting Claudin 18.2, we are now offering a high-quality developed Claudin 18.2 IHC Kit with robust methodological validation! Learn More: https://smpl.is/81vbb #CompanionDiagnostics #DrugDevelopment #Claudin182

  📢 📢 We are happy to announce that our biosimilar for multiple sclerosis (MS), fully developed in-house, was just approved by the EC (European Comission)! We would also like to thank Sandoz, our commercial partner for collaboration in the registration phase. A month ago, we informed you about FDA approval and now not only US patients with multiple sclerosis can look forward to better treatment, but also Europeans.  👏👏 At  Polpharma Biologics #WeCare about the future of those in needs! “We are delighted that the European approval of our biosimilar comes hot on the heels of approval in the U.S., meaning that millions of people with MS around the world may soon have the option of a more affordable treatment for their disease” said Michael Soldan, Chief Executive Officer, Polpharma Biologics Group. We are even more pleased, because our medicine is the first and only biosimilar in Europe for multiple sclerosis. What's more, it was developed from scratch by our team 👩🔬 🧑🔬 This is a huge success for us. Polpharma Biologics retains responsibility for manufacturing and supplying the drug substance. Our commercial partner has the right to commercialize and distribute the biosimilar under an exclusive global license.  👉 For details please follow our article: https://lnkd.in/dUAeb_Et #PolpharmaBiologics #Biosimilars #MultipleSclerosis #WeCare

FDA eases cancer drug shortages by working with manufacturers >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #biotech #pharmaceutical #pharma #productmarketing

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

Amylyx Pharmaceuticals' ALS drug, Relyvrio, didn't meet its goals in the crucial Phase III trial, casting uncertainty on its future. Despite this, the drug's safety profile remained consistent. Considerations - 🔹 The impact on ALS treatment advancements and patient hope. 🔹 Potential regulatory discussions and the commitment to patient well-being may guide Amylyx's next steps. This setback in ALS research emphasizes the challenges in neurodegenerative disease treatment but also the unwavering quest for solutions. #ALS #HealthcareNews #ClinicalTrials

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

Small drops, big impact!    Please, do learn more about the possibilities of remote sampling! Our Sanquin colleagues Suzanne Lanooij and Anne Martens (of the groups of Annick de Vries and Theo Rispens), share their thoughts in a short review article for the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) on how a small finger prick sample, taken at home, can beused for Therapeutic drug monitoring (TDM) of Biologics. https://lnkd.in/erCPUYmY  (paid content)    Home-sampling for TDM of biologics is as reliable as normal venipuncture, and therefore serves as a great alternative since it is less painful, while saving time and costs for all patients. This available diagnostic service can be requested by hospitals.     Are you interested in how small drops of blood at home can have a great impact on patient’s lives? Visit Fingerpricks (https://lnkd.in/esZE2sJJ) or contact us to get started.    #Fingerprick #Homesampling #Microsampling #TDM #IATDMCT

Small drops, big impact! Please, do learn more about the possibilities of remote sampling! My team members Suzanne Lanooij and Anne Martens (in collaboration with Theo Rispens), share their thoughts in a short review article for the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) on how a small finger prick sample, taken at home, can be used for Therapeutic drug monitoring (TDM) of Biologics. https://lnkd.in/erCPUYmY (paid content) Home-sampling for TDM of biologics is as reliable as normal venipuncture, and therefore serves as a great alternative since it is less painful, while saving time and costs for all patients. This diagnostic service can be requested by hospitals. Are you interested in how small drops of blood at home can have a great impact on patient’s lives? Visit https://lnkd.in/e8rqxRUR or contact us to get started. #Fingerprick #Homesampling #Microsampling #TDM #IATDMCT