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: […]
Clinical Trials
Augmenix touts long-term data for hydrogel spacer in prostate cancer patients
Augmenix Inc. said today that long-term outcomes data from the company’s phase III clinical trial evaluating its hydrogel spacer, SpaceOAR, were published in the International Journal of Radiation Oncology Biology and Physics. The spacer is designed to separate the rectum and prostate during prostate cancer radiotherapy, according to the Waltham, Mass.-based company. The newly published data were […]
BioCardia launches pivotal trial for CardiAmp heart failure treatment
BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S. The pivotal trial is a part of the company’s efforts for premarket approval, as regulated by the FDA’s Center for Biologics Evaluation and Research division. “We are honored to be working with the leading […]
Researchers’ bionic pancreas outperforms standard insulin pump therapy
Researchers from Boston University have developed a bionic pancreas system that outperformed conventional insulin pump therapy for patients with type 1 diabetes, according to a trial conducted at Massachusetts General Hospital. The team’s work was published in The Lancet. This device is the latest development in the race to make an entirely closed loop insulin pump system, […]
Eyenovia touts phase II study data
Eyenovia Inc. touted data from its phase II study evaluating the safety and efficacy of its high-precision ophthalmic microtherapeutics compared to conventional eyedropper treatment. The trial comes on the heels of a previous phase II study published in Therapeutic Delivery in October. New York-based Eyenovia’s trial demonstrated that its microdosing achieved superior pharmacologic effects and bioavailability compared to […]
Bristol-Myers, PsiOxus land licensing agreement
Bristol-Myers Squibb (NYSE:BMY) said today that it landed an exclusive licensing agreement for PsiOxus Therapeutics‘ ‘armed’ oncolytic virus, NG-348, for the treatment of solid tumors. According to the agreement, Bristol-Myers will pay PsiOxus $50 million upfront and will assume responsibility for global clinical development and commercialization. PsiOxus will be eligible for $886 million in development, regulatory and […]
Cerus raises funds for phase III trial of Intercept red blood cell system
Cerus Corporation (NSDQ:CERS) said today that it exercised $10.8 million in additional options from its contract with the Biomedical Advanced Research & Development Authority, a part of the U.S. Dept. of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The funds will go towards in vitro pathogen inactivation and red blood cell […]
GSK launches phase III trial for inhaled triple combination therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that they launched a phase III trial evaluating the triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with asthma. The companies’ triple combination therapy is made up of 3 drugs – an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta-adrenergic agonist. The treatment is delivered once a day using GSK’s […]
Brainstorm’s NurOwn stem cell treatment for ALS readies for phase III
Brainstorm Cell Therapeutics (NSDQ:BCLI) said today that it’s preparing for a phase III trial of its NurOwn stem cell treatment, after meeting with the FDA about a biologic license application. The company is developing adult stem cell therapies derived from autologous bone marrow cells to treat neurodegenerative diseases, such as ALS. Hackensack, N.J.-based Brainstorm is planning […]
Japan approves Novocure’s Optune brain cancer treatment
Novocure (NSDQ:NVCR) said today that the Japanese Ministry of Health, Labor and Welfare has approved its tumor treating fields delivery system, Optune, for adult patients with supra-tentorial glioblastoma following surgery and radiation therapy. The St. Helier, N.J.-based company is expected to submit an application for public reimbursement of the device in Japan for newly diagnosed […]
