Sage Therapeutics (NSDQ:SAGE) said today that the FDA accepted its new drug application for an intravenous formulation of brexanolone as a treatment for postpartum depression. The application was accepted under priority review status, according to the Cambridge, Mass.-based company. If approved, the drug would be the first therapy specifically indicated to treat postpartum depression – […]
NanOlogy touts preclinical data for inhaled NanoPac cancer drug
NanOlogy touted results today from preclinical studies of its inhaled submicron particle formulation of paclitaxel, NanoPac. The company said animal studies have shown prolonged retention of the cancer drug in lung tissue and significant tumor regression without adverse drug-related side effects. NanOlogy plans to present the data from its preclinical studies at this year’s annual […]
BioTime lands $1.9m grant to fund dry-AMD drug
BioTime Inc. (NYSE:BTX) said today that it won a $1.9 million grant from the Israel Innovation Authority to help support development of its dry-AMD drug, OpRegen. The company’s investigational therapy delivers retinal pigment epithelial cells into the subretinal space to replace lost RPE cells in patients with macular degeneration. BioTime is testing its drug in a […]
Report: Trump to sign controversial law granting patients access to experimental drugs
President Donald Trump is slated to approve legislation this week that will give terminally-ill patients access to experimental drugs that haven’t yet been cleared by the FDA. The “right-to-try” bill has sparked a great deal of controversy among policymakers and patient groups. While some, including the president, describe the effort as offering hope to patients […]
MIT researchers send drug-ferrying nanoparticles across the blood-brain barrier
Researchers at the Massachusetts Institute of Technology demonstrated in an animal study that nanoparticles shuttling two different cancer drugs could effectively cross the blood-brain barrier and target tumor cells. The team of scientists evaluated the drug combination in mice that had gliobastoma – an aggressive form of brain cancer that is notoriously hard to treat. […]
Reva Medical’s Fantom bioresorbable scaffold succeeds in two-year trial
Reva Medical (ASX:RVA) touted sustained safety and efficacy results for its Fantom bioresorbable scaffold at this year’s EuroPCR meeting. The company also revealed new information about its suite of Fantom Encore products, noting that the devices will have strut profiles of 95 microns, 105 microns and 115 microns. Reva’s Fantom II trial included 240 patients and […]
Biotronik touts two-year study comparing drug-eluting stents
Biotronik yesterday presented two-year data from a trial comparing Boston Scientific‘s (NYSE:BSX) Synergy biodegradable polymer everolimus-eluting stent, Biotronik’s Orsiro sirolimus-eluting stent and Medtronic‘s (NYSE:MDT) Resolute Integrity zotarolimus-eluting stent. Results from the 3,514-patient trial showed no significant difference between the various stents regarding the rate of target vessel failure after two years. But analyses of one-year data found differences between the rates of […]
FDA approves Abbott’s latest drug-eluting stent
Abbott (NYSE:ABT) said today that it won FDA approval for its Xience Sierra everolimus-eluting coronary stent. The company’s device features a thin profile, improved flexibility and longer lengths than previous stents. The device and delivery system were designed to help clinicians tackle complex cases, like those involving multiple or totally blocked vessels, according to Abbott. “We […]
EuroPCR 2018: Study compares drug-coated balloons in patients with arterial in-stent restenosis
At this year’s annual EuroPCR meeting, Boston Scientific (NYSE:BSX touted results from the first trial to compare two drug-coated balloons with different drug formulations – Boston Scientific’s Agent paclitaxel-coated PTCA device and B. Braun’s SeQuent Please balloon. The 125-patient study evaluated the balloons in patients with in-stent restenosis of a lesion previously treated with a drug-eluting […]
Beta Bionics wins FDA nod for home-use trial of artificial pancreas tech
Beta Bionics said this week that it won FDA approval to start recruiting patients with Type I diabetes for home-use studies of its iLet bionic pancreas system. The trial is slated to test Novo Nordisk’s fast-acting insulin, Fiasp, with the company’s autonomous infusion pump in adults with Type I diabetes. The study will also evaluate […]
