Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus. The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee […]
Implants
Ocular Therapeutix doses first patients in pivotal allergic conjunctivitis trial of Dextenza
Ocular Therapeutix (NSDQ:OCUL) yesterday said it dosed the first patients in a Phase 3 clinical trial of its Dextenza drug-device combination. The U.S.-based Phase 3 clinical trial is a multi-center, 1:1 randomized, double-masked, placebo-controlled trial slated to enroll 80 patients. The study will evaluate Dextenza 0.4mg to treat allergic conjunctivitis and ocular itching versus a placebo […]
Senseonics touts long-term safety data on home-use Eversense
Senseonics (NYSE:SENS) yesterday touted real-world data it said demonstrated the safety and lack of adverse events with its Eversense continuous glucose monitoring system for people with diabetes. Eversense is a long-term, implantable GCM sensor with a transmitter that sends discreet vibrations to alert users of low or high glucose. The device can be removed, recharged and […]
Senseonics touts real-world CGM data
Senseonics (NYSE:SENS) announced yesterday that real-world data from its Eversense continuous glucose monitoring system reflected strong performance and safety. The data, published in Diabetes Technology and Therapeutics, included the first 205 U.S. patients to use Germantown, Md.-based Senseonics’ Eversense system over a 90-day wear period. Zero device or procedure-related adverse events were reported with the […]
Ocular Therapeutix’s ophthalmic device gains Medicare coverage early
Ocular Therapeutix (NSDQ:OCUL) said today that the Centers for Medicare and Medicaid Services has assigned a specific and permanent reimbursement J-code for its Dextenza ophthalmic insert, which is approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The code assigned to Dextenza through the Healthcare Common Procedure Coding System will become effective […]
Taris Bio, Bristol-Myers Squibb launch bladder cancer trial
Taris Biomedical has announced the dosing of the first patient in a study of its TAR-200 system plus a programmed immune checkpoint inhibitor for the treatment of muscle-invasive bladder cancer (MIBC). The TAR-200 system continuously delivers the chemotherapy drug gemcitabine in the bladder for multiple weeks. The combination with Bristol-Myers Squibb’s Opdivo (nivolumab) will be […]
Ocular Therapeutix launches Dextenza eye insert
Ocular Therapeutix (NSDQ:OCUL) yesterday announced the commercial launch of its Dextenza ophthalmic insert in the U.S. Dextenza is an ocular insert that is designed to release 0.4 mg of dexamethasone to relieve pain after ophthalmic surgery. It can deliver drugs for up to 30 days after treatment in a physician’s office. The Bedford, Mass.-based company won […]
Louisiana prisoners may get non-FDA-approved naltrexone implant
This article has been updated to clarify the BioCorRx’s role in the program. The Louisiana Department of Corrections is working with BioCorRx (OTC:BICX) to offer soon-to-be-released inmates an opioid addiction treatment implant that has not been approved by the FDA. The implant, which contains a compounded form of naltrexone, is one of several medication-assisted options being […]
Intersect ENT wins preliminary CMS reimbursement code
Shares in Intersect ENT (NSDQ:XENT) got a boost yesterday on news that the Centers for Medicare and Medicaid Services (CMS) had assigned the company’s Sinuva corticosteroid-eluting sinus implant a preliminary J-code. Intersect ENT stock, which had been bumping along just under $30 per share last week, jumped to $33.13 per share at Monday’s market open, […]
Ocular Therapeutix doses first wet-AMD patient in implant trial
Ocular Therapeutix (NSDQ:OCUL) said today that it dosed the first patient in a study of its OTX-TKI tyrosine kinase inhibitor implant. The Phase I trial is slated to assess the bioresorbable device’s safety, durability and tolerability in people with wet age-related macular degeneration. The company’s investigational product is a bioresorbable hydrogel fiber implant formulated with a […]
