The company said QUELIMMUNE, also referred to as SCD-PED, is being used to treat sepsis-associated acute kidney injury in pediatric patients, an ultra-rare market. Its critical care team has been presenting at medical meetings to educate clinicians on the therapy.
Under the clinical supply agreement, Coherus will provide LOQTORZI, toripalimab-tpzi, to Oncolytics for the planned study. Oncolytics is expected to partner with the institution sponsoring the study, which will be named once the trial begins at a premier U.S. cancer center.
According to the company, the first-in-human trial of the BIM-IOL System produced four years of safety and efficacy data and showed control of intraocular pressure that it describes as unprecedented in durability. Pressure control is the central goal of glaucoma treatment, and longer-lastingOptionscould reduce …
Vivani's NanoPortal technology uses miniature implants that release drug over an extended period. The company is applying the platform to GLP-1 therapy, which is commonly given by injection at daily, weekly or monthly intervals. A once or twice yearly regimen could be delivered during …
The company said its US pipeline is expanding, with risingDemandfor the first-generation system, new account wins and steady renewal rates. It linked customer satisfaction to its technology and its operational efficiencies, and said those factors could carry over to a second-generation launch.
OASIZ-301 was randomized, double-blind and placebo-controlled. Participants had a mean baseline score of 10.2 on the European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index, known as ESSDAI, which measures systemic involvement. Each dosing arm included 217 patients in the reported analysis.
CareCloud signed multiple wound care clients during the fourth quarter and was selected as a preferred vendor by Vantage Health Collective, a multi-specialty management services organization. The initial engagement covers three practices in Texas, northern Florida and California.
The planned expansion adds to earlier initiatives involving intelligent health management robots, AI-assisted monitoring, internet hospital connectivity and community-based senior health services. Suncare intends to roll out additional product categories tailored to the everyday health, nutritional and lifestyle needs of older adults.
Three of Bio-Techne's Ella automated immunoassay instruments have been installed and commissioned at Asuragen, which the company says provides the infrastructure required for clinical testing of its assay. Alongside the equipment, inter-laboratory reproducibility studies are underway. These studies compare results from Cleo's MelbourneFacilitywith those …
Breakthrough Therapy designation is a regulatory pathway for serious conditions where early clinical evidence suggests a candidate may offer meaningful improvement over existing options. Holders gain access to the features of Fast Track designation, more intensive FDA guidance on development programs and greater senior-level …