Weian Zhao’s Post

Sebia #FLC are the first EIA tests receiving 510(k) from the #FDA for the quantitative detection of both #kappa and #lambda free light chains in human serum specimens, intended for both aid of diagnosis and monitoring of Multiple #Myeloma and Immunoglobulin Light-Chain (AL-) amyloidosis.  Click to learn more. #sebiausa #Freelightchain #multiplemyeloma #alamaloidosis

Let's meet at CDx in Boston to discuss how NeoGenomics can support your end to end strategy with biomarker and genomics data from over 1M patients tested annually at NeoGenomics! #oncologydata #OncologyRWD

Looking forward to seeing you all in London! Whether you are interested in discussing the next steps in process development, the best validated analytical package to support your programs, or an all-in DS&DP supply, a short chat with us will be worth your while! #advancedtherapies #viralvectors #genetherapy

✨Join Dr. Katharina Schwarz for a Webinar ✨ We’re thrilled to partner with SCIREQ Scientific Respiratory Equipment Inc. and The 3Rs Collaborative (3RsC) to bring you an insightful session led by Katharina Schwarz from Fraunhofer ITEM. Dive into cutting-edge strategies that are revolutionizing drug development for inhalable therapeutics through predictive #invitro and #exvivo models: 📅October 29th, 10-11am, via Zoom! 💡🔎 What you’ll discover: ▶️Precision-Cut Lung Slices (PCLS): Assess drug efficacy and respiratory toxicity of inhalable treatments ▶️P.R.I.T.® ExpoCube® System: Experience dose-controlled, air-liquid-interface exposure for precise modeling ▶️Therapeutic Window Identification: Determine optimal efficacy with minimized local toxicity risks ▶️Data Integration for Predictive Modeling: Combine in vitro and in vivo insights to refine toxicity thresholds and first dose estimations More information about the webinar including a brief speaker spotlight, is available on our website🔗: https://lnkd.in/e8k6TPBV #drugdevelopment #inhalabletherapeutics #PCLS #PRIT #TTC #toxicityassessment

Sarcoidosis Awareness Month! 🗓 As we delve deeper into the Month of Sarcoidosis Awareness, last week marked a pivotal moment for our ongoing efforts in combating #PulmonarySarcoidosis. ODC orchestrated a dynamic Investigator Meeting in collaboration with aTyr Pharma, focusing on our groundbreaking trial currently underway in Brazil, aimed at recruiting patients for this critical cause. The trial sites' collective expertise and commitment generated insightful discussions delving into the trial itself and the intricacies of Pulmonary Sarcoidosis. Together, we are not only advancing science but also reshaping lives! #PulmonarySarcoidosisAwareness #ClinicalResearch #MedicalInnovation

This Friday an FDA advisory committee will meet to discuss the results of a new meta-analysis on the use of minimal residual disease (MRD) as an endpoint to support the accelerated approval of new drugs in multiple myeloma (MM). Currently, drugs in MM are approved based on clinical benefit endpoints, leading to lengthy clinical trials and drug approval timelines and ultimately delays in offering patients potentially beneficial treatments. MRD testing can measure a patients response to treatment by the use of sensitive technologies which measure the level of tumor cells in a patient’s blood. The use of MRD results as an endpoint for drug approval would allow MRD testing to be used to demonstrate drug efficacy instead of clinical response thus shortening clinical trial and drug development times. A recent Diaceutics report on the use and perceptions of MRD found the majority of hematoncologists were comfortable with the use of MRD as a surrogate endpoint in clinical trials. If implemented, this would represent a paradigm shift in the approval of novel therapies. While this discussion is currently limited to MM, the scope for using MRD in drug development and the management of patients is currently being investigated in multiple haematological and solid tumor indications. MRD has the potential to become routine clinical practice in the management of oncology indications and would enable the early detection of disease relapse and allow patient treatments to be adapted accordingly. View the Diaceutics report on MRD at https://lnkd.in/eKu4imxW

Breakthrough approach on MRD which could significantly impact timelines on getting new treatments to patients. If you have not accessed the Diaceutics report on MRD read more at the link below and get in touch. Dr Bob Holt #precisionmedicine #patients #FDA #MRD #cancer

Unlock the truth behind Peptides and Human Cellular Tissue Products in this comprehensive virtual masterclass. Get ready to revolutionize your practice with the All Things Peptides Virtual Masterclass! Happening June 7-8, this event is packed with insights, strategies, and practical applications in peptides and advanced biologics. Why Attend? * Access Recordings: Can’t make it live? All ticket holders get access to recordings of all sessions, presentation slides, and event materials. * Comprehensive Knowledge: Dive deep into peptides and advanced biologics with practical implementation strategies. * Empowerment & Growth: MedMasters aims to educate and empower you with resources to deliver superior therapies, revolutionizing patient outcomes and opening doors to new revenue streams. Don’t miss out! Secure your spot now and elevate your practice. Learn More: https://lnkd.in/ecQzyDFM

If you are attending SCOPE stop by and learn how AliveCor's Kardia devices can optimize your clinical resarch studies!

Zai Lab (NASDAQ: ZLAB, SEHK: 9688)'s partner, argenx, has received FDA approval for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP, offering a once-weekly subcutaneous injection that takes 30 to 90 seconds. This approval is a significant milestone in providing effective and efficient treatment options for CIDP patients. The FDA's decision is backed by the robust data from the ADHERE Study, the largest clinical trial to date for CIDP. The results are impressive: · 69% of patients treated with VYVGART Hytrulo showed clinical improvement in mobility, function, and strength. · A remarkable 61% reduction in the risk of relapse compared to placebo. · 99% of trial participants elected to continue with the ADHERE open-label extension. The safety profile of VYVGART Hytrulo remains consistent with previous clinical studies and real-world use. #FDAApproval #VYVGART #CIDP #ClinicalResearch #HealthcareInnovation #Biotech #MedicalBreakthroughs #QimingPortfolio #QimingHealthcare