Clinical Trial News

Sequana Medical has revealed additional data from its North American pivotal study, POSEIDON, showcasing the alfapump's effectiveness in controlling ascites, improving patients' quality of life, and demonstrating a favorable survival rate. The study, focusing on patients with recurrent or refractory ascites due to liver cirrhosis, also highlighted the device's safety profile and its potential to significantly reduce the need for therapeutic paracentesis.

The CardioMEMS sensor, implanted in heart failure patients, halves emergency hospital admissions by detecting blood pressure changes. A trial showed a 44% reduction in hospitalizations. The device, lasting a lifetime without batteries, sends data to doctors, improving patient management and quality of life.

AVITA Medical has received FDA approval for its RECELL System, a groundbreaking treatment for repigmentation in patients with stable vitiligo. This one-time, point-of-care treatment utilizes autologous skin cells to safely and effectively restore pigmentation, marking a significant advancement in vitiligo care.

The FDA delayed its decision on GSK's momelotinib, a potential myelofibrosis treatment, to review new data, pushing the verdict to Sept. 16. GSK, confident in its application, aims for broader use approval. Despite competition from existing JAK inhibitors, momelotinib offers unique benefits, including anemia reduction, though Jakafi remains the preferred first-line treatment.

4SC AG announced EMA's acceptance of its Letter of Intent for a Marketing Authorization Application for resminostat, with the trade name Kinselby approved. If approved, Kinselby would be the first HDAC inhibitor in Europe for CTCL, marking a significant milestone for 4SC in its commercialization efforts.

The FARETINA-DME study on faricimab showed stable visual acuity in DME patients, with over 70% of previously treated eyes extending treatment intervals. Early signs of vision gains were noted in treatment-naive patients after four injections.

Immix Biopharma completed a $5M ATM equity offering, selling 2,263,868 shares. Funds will support IMX-110 clinical trials and general corporate purposes. The company focuses on CAR-T cell therapies and TSTx for oncology and immuno-dysregulated diseases, with NXC-201 as a leading outpatient CAR-T therapy.

Radionuclide therapies, especially 177Lu-PSMA-617, show promise in treating metastatic castration-resistant prostate cancer (mCRPC), targeting prostate-specific membrane antigen (PSMA) for improved survival. Clinical trials highlight their efficacy and safety, with ongoing research exploring combination therapies and new radionuclides for enhanced treatment outcomes.

AstraZeneca and Sanofi's drug, Beyfortus, for preventing RSV in infants, received unanimous FDA advisory panel support. It's a single-dose, long-acting monoclonal antibody aimed at newborns and infants during their first RSV season. The panel also supported its use for children up to two years old. The drug is already approved in the U.K., EU, and Canada.

The study evaluates imeglimin's effect on type 2 diabetes patients, focusing on HbA1c, GA, and 1,5-AG as glycemic control markers. It examines imeglimin's impact on erythrocytes, hypothesizing prolonged erythrocyte lifespan may affect HbA1c accuracy. The study also explores imeglimin's potential in treating peripheral arterial disease by improving erythrocyte deformability.