Young startups backed by nanoparticle tech face a world hurdles before reaching the clinic. It’s been decades since the first innovations with nanotechnology – and experts are asking, “Where are all the drugs?” It’s been more than 20 years since the FDA approved the first nanoparticle drug, Doxil. At the time, nanoparticles were heralded as a […]
Clinical Trials
J&J’s DePuy Synthes touts 4-year Attune knee revision data
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes today touted 4-year data from a large registry study showing that its Attune knee implant had a lower revision rate than the overall rate for total knee replacement. The study examined data from 10,605 Attune implantations in Britain’s National Joint Registry for England, Wales, Northern Ireland & the Isle of […]
Lamellar Biomedical launches dry-eye trial
Lamellar Biomedical said today that the 1st patients were enrolled in its trial evaluating Lamelleye for the treatment of moderate to severe dry-eye disease. Lamelleye uses the Scotland-based company’s Lamellasome technology to mimic the actions of serous lamellar bodies and regulate interfaces between tissues and external environments. Get the full story at our sister site, […]
Medtronic launches opioid-induced respiratory depression study
Medtronic (NYSE:MDT) said today that it’s starting a large study on the effect of pulse oximetry and capnography in opioid-induced respiratory depression, using its Capnostream device. The 1,650-patient Prodigy study aims to create a tool to score the risk of OIRD in patients being treated with opioids for pain, using Capnostream’s continuous pulse oximetry and capnography monitoring […]
Vascular graft dev Somahlution launches EU registry trial of DuraGraft
Vascular graft developer Somahlution said today it launched the DuraGraft European Registry clinical trial of its DuraGraft device, enrolling the 1st patient in the study. In the registry study, investigators will evaluate the Jupiter, Fla.-based company’s DuraGraft, a vascular graft treatment designed to reduce the burden of ischemia reperfusion injuries, during use in coronary artery bypass […]
InVivo adds Reeve Foundation database to Contempo registry study
InVivo Therapeutics (NSDQ:NVIV) said today it will integrate data from the Christopher & Dana Reeve Foundation’s North American Clinical Trials Network Registry in the Contempo registry study which is complementing its ongoing Inspire study. The Cambridge, Mass.-based company said that the Contempo study looks to provide comprehensive natural history benchmarks for the Inspire study of its […]
BioElectronic launches migraine study for ActiPatch pulsed shortwave therapy
Non-invasive electroceutical developer BioElectronics said today it launched a clinical study of its ActiPatch, examining the use of the device for treating migraines. The ActiPatch is a series of patches or wraps which use electromagnetic pulse therapy to treat chronic pain, according to the Frederick, Md.-based company’s website. In the randomized, double-blinded placebo controlled study, […]
Novo Nordisk seeks to include cardiovascular data in Tresiba insulin label
Novo Nordisk (NYSE:NVO) said today that it submitted a supplemental application to the FDA, asking to include cardiovascular data on the label of its Tresiba insulin degludec. The Danish insulin-maker asked to include data specifically from the Devote trial, which evaluated the cardiovascular safety of Tresiba compared to insulin glargine in patients with Type II diabetes. Get […]
Intensity Therapeutics begins human testing of intratumoral cancer drug
Intensity Therapeutics said today that the 1st patient was treated in a Phase I/II trial of its intratumorally-administered cancer therapy, INT230-6. The company’s plans to evaluate the safety of its cancer-killing agent in patients with tumors that are treated at the surface of the skin, including breast cancer and melanoma. Intensity Therapeutics also plans to […]
Presbia touts preliminary data from Microlens PMA trial
Presbia (NSDQ:LENS) this week reported preliminary data from a US pivotal clinical trial of its Flexivue Microlens, touting that over 80% of subjects had shown significant improvements in vision. The Ireland-based company said it is 27 months into the 3-year trial which it hopes will support US FDA Premarket Approval, and that so far, 100% of subjects […]
Anika launches late-stage supplemental Cingal study
Anika Therapeutics (NSDQ:ANIK) said yesterday that it enrolled the 1st patient in a supplemental Phase III efficacy and safety trial of its Cingal hyaluronic acid-corticosteroid combination viscosupplement. The Bedford, Mass.-bsaed company is evaluating Cingal as a treatment for osteoarthritis-related knee pain. Get the full story at our sister site, Drug Delivery Business News.