Wednesday, March 29, 2023


Biotechnology News Magazine


CytoSorbents Announces Health Canada Regulatory Approval For Pivotal STAR-T Trial

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, "We are very pleased to receive regulatory approval to expand STAR-T into Canada and are now working closely with our partners at the Population Health Research Institute to onboard up to 7 Canadian sites as soon as possible.

REGENXBIO Announces Phase I/II Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy, is Active and Recruiting Patients

RGX-202 is designed to deliver a transgene for a novel microdystrophin protein that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO's proprietary NAV® AAV8 vector.

Illuminare Biotechnologies Announces First Participant Dosed in Phase I Study of Novel Nerve Visualization Investigational Fluorophore

Illuminare-1 is a single dose injectable myelin binding fluorescent agent currently in development by Illuminare Biotechnologies, in collaboration with MSK, to provide real time visualization and delineation of nerves potentially as small as ~60 micron during both open and minimally invasive surgery under blue light illumination. The agent has been shown in animal studies to have an immediate onset of action and a duration of activity between 4-5 hours. Safety has been established in animal models.

ABIONYX Pharma Reports Positive Results from Phase 2a Pilot Clinical Trial Evaluating CER-001 in the Treatment of Septic Patients at High Risk of Developing...

The RACERS study included 20 patients with gram-negative sepsis who were at high risk for acute kidney injury due to high levels of endotoxin activity and decline in function of one or more organ systems.

Revolo Biotherapeutics Completes Enrollment in Phase 2 Trial of ‘1104 in Allergic Disease

“The ability of ’1104 to reduce and reset the inflammatory immune response to common allergens has the potential to provide a long-awaited improvement to disease management with less frequent dosing without immunosuppression,” said Jonathan Rigby, Group Chief Executive Officer of Revolo Biotherapeutics.

Melt Pharmaceuticals’ MELT-300 (Midazolam 3mg and Ketamine 50mg Sublingual Tablet) Achieves Primary Sedation Endpoint in Phase 2 Pivotal Efficacy and Safety Study

MELT-300 combines fixed doses of midazolam (3mg) and ketamine (50mg) in one rapidly dissolving tablet (RDT) that is administered sublingually for procedural sedation during cataract surgery.