Oricell GPRC5D CAR-T Therapy Clears FDA IND Hurdle, Paving the Way for Global Impact
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Oricell GPRC5D CAR-T Therapy Clears FDA IND Hurdle, Paving the Way for Global Impact
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Director at BlueRock Therapeutics | Cell and Gene Therapy | Biologics CMC | Regulatory and Compliance | Formulation and Process Development
#Eohilia, as the first and only oral treatment in the US for Eosinophilic Esophagitis (#EoE), is truly a formulation and drug delivery success. The formulation contains the thixotropic agent (e.g., #Avicel RC-951), which imparts unique rheological properties to the oral formulation. These properties allow the drug suspension to become more fluid when shaken, and then return to a viscous gel state once swallowed. A viscous gel state is ideal for improving the mucoadhesion and increasing the residence time of the drug on the esophageal mucosa for EoE treatment. #formulations, #drugdelivery
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A look back at the MGCD Archive Did you know... In 1983, MGC Diagnostics played a key role in evaluating the effectiveness of a new pharmaceutical drug. We assisted an international firm in assessing the drug's ability to prevent certain forms of heart disease. This project exemplifies our ongoing commitment to innovation in cardiorespiratory diagnostics. We're proud to be a part of advancements that improve patient care and heart health! Want to learn more about our history of innovation in cardiovascular health? Visit https://lnkd.in/g5ha7pwZ to discover how MGC Diagnostics continues to shape the future of medical diagnostics. #cardiovascularhealth #pharmaceuticalresearch #diagnostics #historyofmedicine #respiratory #pulmonary #lunghealth
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📖 NEWLY PUBLISHED IN NEUROMODULATION 📖 "Real-World Prescription Data for Intrathecal Drug Delivery: A Retrospective Analysis in 32,784 Patients" 👉 https://lnkd.in/giFmp8Pu HOW TO CITE 👉 Hao D., Di Capua C.A., Dumas C., Rosenblum S., Thorne R., Narang S. 2024. Real-World Prescription Data for Intrathecal Drug Delivery: A Retrospective Analysis in 32,784 Patients. Neuromodulation 2024; -: 1–5. @DepthAnesthesia
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Analysts expect the companies’ Eylea HD and Vabysmo to generate $13.2 billion between them by 2030 in the vascular endothelial growth A therapy market, as healthcare providers and patients switch from older products. #pharma #biospace https://hubs.li/Q02NBb4c0
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Heart failure (HF) treatment is cumbersome and targets for intervention are multifactorial. Our standard of care for HFrEF has emerged with pharmaceutical options, device therapies, and lifestyle modifications. The association between ejection fraction (EF) and clinical outcomes has been well established. For those patients with HFpEF, the current guidance for medical therapy may not be enough and we should look beyond EF. Advanced practice providers are an integral part of the team approach in treating heart failure and should be abreast of various ways to improve patient outcomes. 💓 Read the full article at https://heyor.ca/L5Zg1r
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News from Pharmacy Learning Network: In this installment of Talking Therapeutics, Dr Jennings explores another potentially dangerous direct-acting oral anticoagulant (DOAC) combination based on a recent study. Learn more about why it may be time to reconsider Diltiazem as first-line treatment. #PharmacyLearningNetwork #PLN #DOAC #druginteractions
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One of the most important factors in planning a cell therapy program is the Quality Control (QC) process to meet at a minimum the mandatory prescribed assays by key regulatory agencies. Starting with donor screening, REPROCELL's process ensures that the starting iPSCs for your cell therapy meet the highest standards as described by FDA, EMA, and PMDA regulations. Our QC paradigm builds as the project progresses adding additional, more detailed assays at each step. This process ensures that therapeutic iPSCs meet the highest safety standards. Find out how REPROCELL can help your project: https://hubs.li/Q02tK7010
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"The committee of outside experts voted 11-0 that donanemab’s benefits outweigh its risks. It also voted 11-0 that the data presented by Indianapolis-based Lilly showed the drug was effective. One question the FDA will have to decide is whether treatment with Lilly’s drug can stop once its shown an effect. In Lilly’s trial, patients stopped receiving donanemab once amyloid plaques, thought by some to cause the disease, were largely cleared from their brains. Biogen and Eisai, in contrast, suggest that their amyloid-busting drug Leqembi be given indefinitely... Lilly also compared the efficacy of its drug in patients with slightly earlier or more advanced disease, determined by how much of the protein tau had built up in their brain. It was more effective in patients with less tau and less advanced disease. " But Kevin Krudys, a clinical efficacy reviewer at the FDA, said there is “considerable uncertainty” about how much amyloid needs to be reduced for benefit. Although Lilly said that amyloid was slow to reaccumulate when patients stopped taking donanemab, Krudys noted that data from a short period of the company’s study, and that Lilly did not include an appropriate comparison group. Removing amyloid early in the course of the disease appears to modestly slow cognitive decline, but it can also cause signs of brain bleeding and swelling known as amyloid-related imaging abnormalities, or ARIA. Reisa Sperling, a neurologist and clinical investigator at Massachusetts General Hospital, said that ARIA seems to be a side effect inherent to the entire drug class." https://lnkd.in/gkuPCSv9
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𝗣𝗹𝗶𝗮𝗻𝘁 𝘁𝗼𝘂𝘁𝘀 𝗮𝗱𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹 𝗣𝗵𝗮𝘀𝗲 𝟮𝗮 𝗱𝗮𝘁𝗮 𝗳𝗼𝗿 𝗼𝗿𝗮𝗹 𝗜𝗣𝗙 𝗱𝗿𝘂𝗴 𝘁𝗵𝗮𝘁’𝘀 𝗮𝗹𝗿𝗲𝗮𝗱𝘆 𝗶𝗻 𝗮 𝗽𝗶𝘃𝗼𝘁𝗮𝗹 𝘀𝘁𝘂𝗱𝘆 Pliant Therapeutics unveiled more efficacy data from a small mid-stage trial of its lead candidate in idiopathic pulmonary fibrosis, which shows that its oral drug could potentially reverse fibrosis. The Phase 2a trial had a primary endpoint of change in type 1 collagen in the lung, as measured by standardized uptake value (SUV) of a certain radiotracer that binds to this form of collagen. In 10 evaluated patients, bexotegrast led to a mean 0.015 reduction from baseline in the top quartile SUV, versus a mean 0.074 increase for placebo, according to a company release. Bernard Coulie, Pliant Therapeutics CEO https://lnkd.in/eFz2JTrS
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In MedCity News, the potential of BioAge’s lead compound as an oral medication to increase weight loss while maintaining healthy body composition in patients on GLP-1 drugs: “Obesity is the indication we are focusing on given the strong weight loss synergy we see preclinically with incretins. This is an oral drug with the potential to increase weight loss quantity with a fully oral regimen, as well as to improve weight loss quality.” https://lnkd.in/gQ_dR3Wf
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