Clinical Trial News

Elutia Inc. celebrates one-year anniversary with FDA approval for EluPro™, 20% sales growth, and 170% shareholder value increase.

Relay Therapeutics to report interim data for RLY-2608 600mg BID + fulvestrant in 2L+, CDK4/6-experienced patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer on Sept. 9, 2024, at 8am ET.

GSK announced positive results from the MATINEE phase III trial, showing Nucala (mepolizumab) significantly reduced COPD exacerbations. Nucala targets IL-5 in type 2 inflammation, with consistent safety results. Full data will be presented at a future scientific congress.

FDA grants EUA to Novavax's updated COVID-19 vaccine for individuals aged 12+, available in U.S. pharmacies. FDA clears first digital therapeutic, DaylightRX, for GAD treatment. Embecta receives 510(k) clearance for disposable insulin patch pump for T1D and T2D patients. FDA authorizes BioVie's IND for phase 2 trial of bezisterim to treat neurological symptoms of post-COVID-19 condition.

Tareen Dermatology partners with CLINUVEL for phase 3 CUV 105 trial evaluating afamelanotide plus NB-UVB phototherapy for vitiligo, targeting Fitzpatrick skin types IV-VI. The study aims to assess superior repigmentation compared to NB-UVB monotherapy, with afamelanotide administered as a 16 mg subcutaneous implant every 3 weeks for 5 months, followed by a 6-month follow-up. Previous phase 2 results showed faster and more significant repigmentation with combination therapy, though challenges include patient eligibility and potential adverse effects like diffuse hyperpigmentation.

Leading physicians and researchers will present results from 21 clinical trials at the 2024 VIVA and The VEINS conferences at Wynn Las Vegas, emphasizing innovation and multidisciplinary learning in vascular medicine and intervention.

FDA approves nimodipine (Nymalize) oral solution in 30 mg/5 mL prefilled ENFit syringes, enhancing safety for subarachnoid hemorrhage patients.

Boehringer Ingelheim and CDR-Life report positive Phase I results for BI 771716, an antibody fragment targeting geographic atrophy (GA), meeting safety endpoints. The companies plan to initiate Phase II trials in early 2025, aiming to preserve vision in GA patients, a severe form of AMD leading to irreversible vision loss. BI 771716's design allows optimized retinal penetration and efficacy potential.

Splash Clinical and Cambridge Cognition partner to integrate CANTAB into Splash's patient recruitment platform, enhancing CNS trial recruitment efficiency and quality.

Aleksandra Staniszewska et al. developed a core outcome set for interventions in diabetes-related foot ulceration studies, published in *Diabetes Care* 2024; dc241112. https://doi.org/10.2337/dc24-1112