Regeneron Pharmaceuticals (NSDQ:REGN) announced data supporting the use of its EYLEA injection in NPDR patients. Protocol W, a NIH-sponsored trial to evaluate the EYLEA (aflibercept) injection in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR), without center-involved diabetic macular edema (CI-DME), had its initial results published in JAMA Ophthalmology. At two years, the primary […]
Clinical Trials
Fractyl enrolls first patient in Revita DMR treatment for Type 2 diabetes
Fractyl Laboratories announced today that it enrolled the first patient in the trial for its Revita DMR Type 2 diabetes treatment. The Revita-T2Di trial will evaluate a single Revita DMR treatment to allow patients currently on insulin therapy but with inadequate glycemic control to achieve durable insulin-free glycemic control. The company will seek to use […]
Insulet touts results from Omnipod 5 study, expects launch this year
Insulet (NSDQ:PODD) touted positive results from the first pivotal trial for its Omnipod 5 automated insulin delivery system. Omnipod 5 is the world’s first tubeless, wearable system designed to continuously adapt insulin delivery based on glucose levels and trends, according to a news release. Acton, Mass.-based Insulet said the device, which has FDA breakthrough device […]
FDA approves oral multiple sclerosis treatment from J&J’s Janssen unit
Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical announced today that it received FDA approval for its Ponvory treatment. Ponvory (ponesimod) is a once-daily, oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator for treating adults with relapsing forms of multiple sclerosis (MS). It’s areas of treatment include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, […]
How Lyra Therapeutics is advancing rhinosinusitis treatment
With the use of anti-inflammatory drugs constituting the standard of care for treating rhinosinusitis, Lyra Therapeutics sees an opportunity. Whatever treatments are out there for the disease in which cavities around the nasal passages are inflamed, they leave room for improvement. “We focused on chronic rhinosinusitis because it’s an area that has been ignored,” Lyra […]
Eyenovia touts study of pupil dilation treatment
Eyenovia (NSDQ:EYEN) today announced positive results from a study of its microdose array print (MAP) pupil dilation technology. Study data, published in Therapeutic Delivery, revealed pooled results from two prospective, double-masked, controlled, cross-over superiority Phase 3 studies. Those results concluded that a micro-dosed fixed-combination of tropicamide 1% and phenylephrine 2.5% for pupil dilation (mydriasis) is safe and […]
Oramed reaches 25% randomization in oral insulin trial, expects topline results in 2022
Oramed Pharmaceuticals (NSDQ:ORMP) announced that it reached 25% randomization in the enrollment for its oral insulin capsule trial. New York-based Oramed’s Phase 3 ORA-D-013-1 study for the ORMD-0801 oral insulin capsule for the treatment of Type 2 diabetes has planned for 675 patients overall, reaching a quarter of that mark in enrollment so far with […]
HTX Urology set to participate in study for Urotronic’s prostate treatment device
Urotronic announced that HTX Urology is participating in an FDA-cleared study for a minimally invasive device for treating enlarged prostates. Plymouth, Minn.-based Urotronic’s Optilume BPH (benign prostatic hyperplasia, otherwise known as enlarged prostate) catheter system is an outpatient procedure designed to combine balloon dilation to open the prostate and local drug delivery to maintain symptom […]
How Bionaut Labs aims to tackle brain tumors with microrobots
The roboticist Michael Shpigelmacher was one of the founders of PrimeSense, a robotic 3-D vision technology company Apple acquired in 2013. PrimeSense created technology empowering the Microsoft Xbox Kinect and the iPhone’s Face ID feature, allowing users to use facial recognition to unlock their phones. Now Shpigelmacher has set his sights on drug-delivery with Bionaut […]
AVEO to collaborate with Bristol Myers Squibb on renal cell carcinoma drugs
AVEO Oncology (NSDQ:AVEO) announced today that it entered into a clinical trial collaboration with Bristol Myers Squibb. Boston-based AVEO’s collaboration and supply agreement with Bristol Myers Squibb is slated to evaluate Fotivda (tivozanib) in combination with Opdivo (nivolumab), an anti-PD-1 therapy developed by Bristol Myers Squibb. The drugs will be evaluated in a pivotal Phase […]
