Cerveau Technologies said today that the FDA cleared the investigational new drug application for its tau imaging agent. The company plans to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess neurofibrillary tangles in the brain. NFTs composed of aggregated tau protein are characteristic of certain neurodegenerative conditions like […]
Clinical Trials
Blaze Bioscience touts Phase 1 data from pediatric oncology Tumor Paint BLZ-100 study
Oncology-focused biotech company Blaze Bioscience today released clinical data from the Phase 1 study of its Tumor Paint BLZ-100 in pediatric brain cancer patients, touting that the agent was well tolerated. Data from the study was presented at the 4th Biennial Pediatric Neuro-Oncology Basic and Translational Research Conference in New York. The BLZ-100 is the […]
Sanofi, Parexel collaborate on clinical trial data collection wearables
Parexel said today it is collaborating with Sanofi (NYSE:SNY) to develop and promote wearable devices to improve collection of data during clinical trials. Through the collaborative deal, the 2 companies will leverage their specific expertise to explore how wearables could improve study performance and new drug development and how sensors from several wearable devices could be […]
pSivida implant meets primary endpoint in late-stage trial
pSivida (NSDQ:PSDV) touted data from the 2nd Phase III trial of its Durasert 3-year treatment for posterior segment uveitis. The company reported that the trial, which followed patients for 3 years, met its primary endpoint of prevention of recurrence of posterior uveitis at 6 months. In the 153-patient trial, 21.8% of Durasert-treated patients had a […]
Adapt Pharma touts usability data for Narcan nasal spray
Adapt Pharma touted data today from 2 human factors studies that evaluated the usability of its Narcan nasal spray by adolescents and people with low literacy. The Dublin-based company’s product is a ready-to-use, needle-free device that delivers a single dose of naloxone in a nasal spray to someone experiencing an opioid overdose and does not require […]
Cleveland Clinic spinout Infuseon wins FDA nod for CNS drug delivery device
Cleveland Clinic spinout Infuseon Therapeutics said today that its novel central nervous system delivery device won 510(k) clearance from the FDA as a therapeutic delivery device. The company’s Cleveland Multiport Catheter, which won FDA clearance in March, was designed to effectively deliver therapeutics to the brain. Usually, the blood brain barrier prevents drugs delivered in […]
BTG touts digital patient engagement platform with TheraSphere treatment
BTG (LON:BTG) touted data last week from a pilot study of its digital patient engagement platform IO Loop in patients with primary hepatocellular carcinoma undergoing treatment with the company’s TheraSphere transarterial radioembolization therapy. The study found that patients experienced sustained quality of life up to 3 months after treatment. The company touted the study of […]
ADA 2017 Roundup: Photo ban causes stir among conference attendees
Many scientific conferences have embraced the technological age, creating hashtags for attendees to share content on Twitter and engage with one another. Some conferences even acknowledge attendees with powerful social media presences by giving them special ribbons and including their Twitter handles on their name badges. But at this year’s meeting of the American Diabetes […]
Medtech stories we missed this week: June 9, 2017
From 3M’s expanded 510(k) clearance for its Tegaderm dressing to Medtronic and Acacia burying the hatchet, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks Taiwanese distro deal for CGuard InspireMD announced in a June 8 press release that it has signed a distribution deal with […]
Inovio launches late-stage cervical dysplasia trial after FDA lifts hold
Shares in Inovio Pharmaceuticals (NSDQ:INO) jumped more than 10% after it announced that it is launching a Phase III clinical study of its investigational DNA immunotherapy candidate designed to treat cervical dysplasia caused by human papillomavirus. The moves comes after the FDA lifted a hold that it placed on the clinical program in October last year. At […]