Noveome Biotherapeutics announced that it entered a commercial license agreement to use SipNose’s proprietary drug delivery device. Yokneam, Israel–based SipNose develops its intranasal Cribriform Targeted Device (CT6), which, under the agreement, was licensed to Noveome to deliver the Pittsburgh-based company’s ST266 biologic to the central nervous systems, according to a news release. CT6 allows aerosolized […]
Clinical Trials
NRx Pharmaceuticals touts Zyesami results, seeks EUA for treating COVID-19
NRx Pharmaceuticals (NSDQ:NRXP) announced that it applied for FDA emergency use authorization based on a study of its Zyesami therapeutic. Radnor, Pa.-based NRx Pharmaceuticals, formerly NeuroRx, just last week completed a merger with SPAC Big Rock Partners Acquisition Corp. and went public, changing its name in the process. The company develops Zyesami, a synthetic form […]
DarioHealth touts research on digital therapeutics for diabetes patients
DarioHealth (NSDQ:DRIO) announced today that recently published research supports its digital therapeutic platform for type 2 diabetes. New York-based DarioHealth published a new study through a letter to the editor in the Journal of Diabetes Science and Technology, according to a news release. The study observed participants using DarioHealth’s digital therapeutics for diabetes management, monitoring […]
Avalyn Pharma touts study of aerosolized pulmonary fibrosis treatment
Avalyn Pharma announced today that it observed statistically significant success in a study of its aerosolized pulmonary fibrosis treatment. Seattle-based Avalyn presented data from a 24-week Phase 1/2 clinical study at the ISAM conference in Boise, Idaho. The data covered two dose regimens of AP01, a formulation of pirfenidone optimized for delivery through inhalation in […]
FDA issues draft clinical trial guidelines for neurostim, other devices to treat diabetes
The FDA today issued a draft guidance with recommendations for clinical trials for certain devices intended for treating diabetes. Included in the guidance are recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus, independent of medication delivery. Among the […]
Neurodon prepping IND application for type 1 diabetes treatment
Neurodon announced today that it initiated studies to prepare an FDA Investigational New Drug (IND) application for its type 1 diabetes treatment. Crown Point, Ind.-based Neurodon’s NDC-0009 novel molecule targets endoplasmic reticulum (ER) stress, a pathway triggered by factors arising from disease that features in type 2 and type 2 diabetes, as well as inflammation […]
Boston Scientific initiates coronary drug-coated balloon study in U.S.
Boston Scientific (NYSE:BSX) this week launched its Agent IDE trial for its Agent drug-coated balloon. The U.S. prospective, randomized clinical trial will evaluate the safety and effectiveness of a drug-coated balloon (DCB) in patients with coronary in-stent restenosis in lesions up to 26 mm in length in a coronary artery 2.0 mm to 4.0 mm in […]
Qpex Biopharma initiates Phase 1 study of oral anti-infective therapy
Qpex Biopharma announced today that it dosed the first patient in a Phase 1 study of its ORAvance inhibitor for bacterial infections. San Diego-based Qpex designed its ORAvance ultra-broad-spectrum oral beta-lactamase inhibitor for use in combination with beta-lactam antibiotics for drug-resistant gram-negative bacterial infections, according to a news release. ORAvance delivers QPX7728 in an oral […]
Virta Health touts one-year outcomes for diabetes reversal tech in Native American tribal nation
Virta Health announced today that one-year outcomes for its diabetes reversal tech proved successful on a number of levels. San Francisco-based Virta’s results came from its multi-year partnership with the Mashantucket Pequot Tribal Nation. Native Americans suffer from the highest rates of type 2 diabetes compared to any other ethnic group in the country, with […]
FDA accepts IND application for Samus Therapeutics’ oral glioma drug
Samus Therapeutics announced today that the FDA cleared its investigational new drug (IND) application for its glioma treatment. Boston-based Samus Therapeutics develops the PU-AD (icapamespib) orally administered small molecule drug for the treatment of recurrent malignant glioma, according to a news release. Under the IND, Samus will move forward with its Phase 1b study to […]