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, […]
Clinical Trials
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 […]
Flamel Technologies dose first patient in Phase III narcolepsy trial
Flamel Technologies (NSDQ:FLML) said today that the 1st patient in its Rest-On phase III clinical trial was dosed with FT218, sodium oxybate, for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients.The Lyon, France-based company developed the controlled-release oral formulation of sodium oxybate using its Micropump technology. The randomized, double-blind trial has enrolled […]
Galderma wins FDA nod for dermal fillers
Galderma said today that it won FDA approval for 2 of its products to treat nasolabial folds, or “laugh lines”. The Fort Worth, Texas-based company’s Restylane Refyne and Restylane Defyne are made with XpresHAn technology to manufacture injectable gels with customized hyaluronic acid crosslinking in each product. The federal watchdog’s approval was based on 2 […]
BioDelivery’s topical gel for diabetic neuropathy fails in phase IIb trial
BioDelivery Sciences International (NSDQ:BDSI) said today that its clonidine topical gel for pain relief in patients with diabetic neuropathy failed in a phase IIb clinical trial. Raleigh, N.C.-based BioDelivery will halt any further development of the painkiller. In the phase IIb clinical trial, BioDelivery’s topical gel did not demonstrate a statistically significant difference in pain relief […]