Braeburn Pharmaceuticals and Camurus (STO:CAMX) touted data today from a long-term Phase III study of its weekly and monthly buprenorphine depots in patients with moderate-to-severe opioid use disorder. The safety and efficacy study enrolled 228 patients and 71% of participants completed the 48-week treatment. The safety profile of CAM2038 was comparable to previous, shorter studies, […]
Clinical Trials
Philips touts consistency, reproducibility in HeartModel AI 3DE imaging study
Royal Philips (NYSE:PHG) today released data from a study of automated 3D echocardiogram analyses with its HeartModel A.I. ultrasound software, touting it as an accurate alternative to conventional methodology. Results from the study were published in the European Heart Journal. The study aimed to explore the accuracy and reproducibility of left atrial volume, left ventricular […]
Kala touts Phase III data for nanoparticle ophthalmic suspension
Kala Pharmaceuticals touted data today from a Phase III trial of its nanoparticle formulation of loteprednol etabonate as a treatment for inflammation and pain in cataract surgery patients. The KPI-121 1% suspension met both primary efficacy endpoints and secondary endpoints and was well tolerated by the trial’s participants. The Waltham, Mass.-based company’s KPI-121 uses Kala’s mucus-penetrating […]
Aeterna shares tumble after cancer-killing agent fails in Phase III trial
Shares in Aeterna Zentaris (NSDQ:AEZS) fell more than -50% this morning after the company said that the Phase III trial of Zoptrex did not meet its primary endpoint in women with locally advanced, recurrent or metastatic endometrial cancer. The ZoptEC pivotal trial was designed to evaluate the safety and efficacy of a hybrid molecule made up […]
Artificial pancreas shows promise in pediatric study
A pilot study evaluating an artificial pancreas in children with Type I diabetes found that the device helped kids control their condition, according to researchers at the University of Virginia. The artificial pancreas was developed at the UVA Center for Diabetes Technology and features a smartphone powered by algorithms that wirelessly link to a glucose monitor […]
Boston Scientific looks to lead the drug-eluting PAD market
Angioplasty is not a new procedure – doctors have been widening obstructed arteries with balloons since the 1960s. But for years the medtech industry has been plagued with what Jeff Mirviss, president of Boston Scientific’s interventional peripheral biz, calls the procedure’s Achilles heel: Restenosis. For patients treated with bare balloons, half must have the procedure done again […]
Midazolam nasal spray trial meets primary endpoint in patients with seizure clusters
Proximagen Ltd. said today that its pivotal Phase III trial of intranasal midazolam met its primary efficacy endpoint as a treatment for patients with seizure clusters. The Cambridge-based company said it plans to begin talks with the FDA for a New Drug Application in the 2nd half of this year based on the trial’s findings. […]
Braeburn’s risperidone implant meets primary endpoint in schizophrenia trial
Braeburn Pharmaceuticals said yesterday that a 6-month study of its risperidone implant in patients with schizophrenia or schizoaffective disorder met its primary endpoint. Risperidone, the most commonly-prescribed therapy for schizophrenia, depends on consistent administration, but patients with schizophrenia sometimes stop taking their medication when their symptoms improve. Long-acting, injectable formulations of risperidone are on the market, […]
LimFlow wins FDA IDE to launch end-stage CLI treatment trial
LimFlow said today it won FDA investigational device exemption to launch a feasibility study of its LimFlow percutaneous deep vein arterialization system in patients with end-stage critical limb ischemia. The company said that the study will examine the use of its system in treating CLI patients facing major amputations. The system is designed to bypass blocked […]
Medtronic touts long-term data from VenaSeal studies
Medtronic (NYSE:MDT) touted 3-year outcomes from a pivotal clinical trial and 1-year data from the Waves study of its VenaSeal closure system in patients with venous reflux disease. Dr. Kathleen Gibson, from Lake Washington Vascular, presented the data at the 2017 Charing Cross Symposium. Both studies demonstrated long-term clinical benefits and improvement in quality of […]
Medtronic touts 5-year Endurant II AAA registry data
Medtronic (NYSE:MDT) today released 5-year data from the Engage global registry study of its Endurant II abdominal aortic aneurysm stent graft, touting long-term durability and consistent outcomes with the device. Results from the study, which the company claims is the most robust post-market registry of endovascular aortic repairs to date, was presented at the 2017 […]