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 […]
FDA approves delivery system for Intersect ENT’s Propel implant
Intersect ENT (NSDQ:XENT) said today that it won FDA approval for a new delivery system for its Propel Mini steroid-eluting sinus implant. The Menlo Park, Calif.-based company said the straight delivery system is designed to place the mometasone furoate-eluting Propel Mini in the ethmoid sinus behind the nasal bridge. The SDS is slated to hit […]
Eli Lilly, Aptar win FDA approval for nasal glucagon powder
Eli Lilly (NYSE:LLY) and AptarGroup (NYSE:ATR) today won FDA approval for the first injection-free glucagon for treating severe low blood sugar in diabetes patients. The federal safety watchdog’s approval, of Lilly’s Baqsimi nasal powder and the delivery device developed by Aptar for treating severe hypoglycemia, was based on two studies comparing a single dose of Baqsimi […]
FDA issues new postmarket guidance for drug-device products
The FDA has released final postmarket guidance for manufacturers of drug-device combination products. The guidance outlines how the agency expects manufacturers of combination products and those that make constituent parts of drug-device combinations to report adverse events and product malfunctions. Combination-product manufacturers will have five working days to report adverse events that require remedial action […]
Teva wins FDA approval for AirDuo Digihaler for asthma
Teva (NYSE:TEVA) yesterday said that it received FDA approval for its AirDuo Digihaler Inhalation Powder. The Israel-based company’s AirDuo Digihaler is a combination therapy digital inhaler with built-in sensors that can connect to a smartphone application, indicated to treat asthma in people 12 years and older.. It delivers a multi-dose dry powder of 113mcg of fluticasone […]
Avoset to develop infusion pump with unnamed pharma giant
Avoset Health said this week that it plans to develop a connected infusion pump with an unnamed pharmaceutical company. The product is set to debut in early 2021. The company touted that its technology allows physicians and pharmacists to track when patients receive infusions, how much drug was infused and which patients need additional intervention. […]
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 […]
Clearside Biomedical licenses microinjector to Aura Biosciences
Clearside Biomedical (NSDQ:CLSD) said today that it licensed its microinjector technology to Aura Biosciences for use with Aura drug candidates in treating ocular cancers. Alpharetta, Ga.-based Clearside’s Suprachoroidal Space Microinjector is designed to deliver therapeutics into the suprachoroidal space between the sclera and choroid of the eye. Aura, based in Cambridge, Mass., is developing viral nanoparticle […]
Valeritas touts study results
Valeritas (NSDQ:VLRX) today announced the results of a study that showed patients using its V-Go wearable insulin delivery device needed less insulin, had lower A1c levels and reduced diabetes-related medication cost compared with patients using multiple daily injection (MDI) therapy. The retrospective study by the Bridgewater, N.J.-based company used information from the HealthCore Integrated Research Database […]
Kurve, Suerat partnered in nasal-delivery migraine treatment deal
Kurve Technology last week announced a new development and collaboration agreement with Seurat Therapeutics for migraine prevention in adults. Mill Creek, Wash.-based Kurve Technology develops and markets intranasal drug delivery devices that transport liquid compounds from the nose to the brain to treat Alzheimer’s PTSD, multiple sclerosis and more. “Both Seurat and Kurve are proud […]
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