By Ronald Boumans, Emergo Group In 2016, we discussed the possible options for what a Brexit could look like and what the British prime minister meant with “Brexit means Brexit.” The official date of announcing formally that the United Kingdom wants to leave the European Union is fast approaching. Get the full story here at […]
Regulatory/Compliance
Ocular Therapeutix resubmits NDA for Dextenza
Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a New Drug Application to the FDA for its post-surgical ocular pain reliever. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery. The Bedford, Mass.-based company has had trouble gaining regulatory approval for the […]
Sanofi’s Suliqua combination therapy approved in European Union
Sanofi (NYSE:SNY) said today that the European Commission granted marketing authorization in Europe for its Suliqua combination product for adults with type II diabetes. The therapy is a fixed-ratio combination of basal insulin glargine and lixisenatide, intended to be used with metformin to improve patients’ glycemic control. Suliqua will be available in 2 pre-filled SoloSTAR pens at […]
Pulmatrix shares soar after winning FDA designation
Pulmatrix (NSDQ:PULM) shares were up 159% to $1.79 apiece in mid-afternoon trading today after the company announced that its drug candidate for treating fungal infections in the lungs of cystic fibrosis patients was designated as a ‘qualified infectious disease product’ by the FDA. With the designation, the Lexington, Mass.-based company will receive 5 years of […]
South Korean medical device regulatory changes updates
By Stewart Eisenhart, Emergo Group Enforcement dates for various new and updated medical device regulations in South Korea have now gone into effect, according to Emergo consultants in Seoul. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those […]
Dexcom surges on Medicare nod for continuous glucose monitors
DexCom (NSDQ:DXCM) said yesterday that the Centers for Medicare & Medicaid classified therapeutic continuous glucose monitors as durable medical equipment under Medicare Part B. The company’s Dexcom G5 Mobile is the only CGM system that falls under this classification, according to San Diego, Calif.-based DexCom, since patients can make treatment decisions using the device. DXCM […]
Keystone Nano wins FDA nod for nanoliposome cancer treatment
Keystone Nano said today that the FDA approved its investigational new drug application for the ceramide nanoliposome as a treatment for solid tumors. The company will launch a phase I trial at 3 sites to evaluate safe dosing levels and the product’s efficacy as a cancer therapy. Ceramide is a lipid that has demonstrated efficacy in […]
Neurelis wins fast track designation from FDA for intranasal diazepam spray
Neurelis, Inc. said today that it won fast track designation from the FDA for its intranasal diazepam spray. The nasal formulation of diazepam, which is being developed for pediatric and adult epilepsy patients who experience repititive or cluster seizures, is in the final stage of clinical development, according to Neurelis. The company expects to submit […]
Ocular Therapeutix touts data from phase III trial of Dextenza
Ocular Therapeutix (NSDQ:OCUL) touted interim data today from its phase III trial of Dextenza for the treatment of post-surgical ocular inflammation and pain. The bioresorbable intracanalicular hydrogel plug is designed to release drugs at the ocular surface for up to 30 days. The company announced last month that Dextenza met the trial’s 2 primary efficacy endpoints: […]
FDA accepts Allergan’s new drug application for Liletta contraception device
Allergan (NYSE:AGN) and the global nonprofit women’s health company Medicines360 said today that the FDA accepted its supplemental New Drug Application for the Liletta contraception device. The companies are asking the federal watchdog to extend the system’s duration of use from 3 years to 4 years. Liletta is a levonorgestrel-releasing intrauterine system that is placed […]
