In what is claimed as the first co-authored research between regulatory scientists at the U.S. FDA and a commercial manufacturer of organ-on-a-chip devices, CN Bio's Physiomimix system is shown to perform better than the current standard in vitro liver toxicity tests. In addition to maintaining its function for longer than 2D hepatocyte cultures or 3D spheroids, Physiomimix was found to reproducibly assess toxicity, metabolism and intracellular accumulation of drugs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkermes, Apnimed, Eloxx, Evelo, Faron, Forma, Jemincare, Ocular, Ocuphire, Seneca, Sumitomo, Dainippon, Synairgen, Theralase, Tris.
Aclaris Therapeutics Inc. CEO Neal Walker said “a lot of room within rheumatoid arthritis [RA]” remains for new drugs, such as his firm’s orally delivered ATI-450. “We see opportunities given the profile, the relative efficacy and safety that we've already demonstrated, to look at not only potentially monotherapy or earlier treatment of disease but also combo treatment, particularly given the safety profile. I think it's pretty well-known that polypharmacy is the rule in this indication.”
The U.S. Preventive Services Task Force (USPSTF) appears on the verge of expanding colorectal cancer screening to individuals ages 45 to 49, based on its latest draft recommendations. If it does, Exact Sciences Corp. is ready. A study in Cancer Prevention Research demonstrated that the Madison, Wis.-based company's Cologuard multitarget stool DNA test had better than 95% specificity in individuals with nonadvanced precancerous lesions or negative findings on colonoscopy.
Opticyte Inc., a medical device startup, is planning the first clinical trial of its cellular oxygen monitor, a new device that could help emergency physicians diagnose sepsis faster and prevent organ failure. The prospective, observational trial is set to launch in mid-2021.
With the table set for phase III data due next month from a trial testing Travere Therapeutics Inc.’s sparsentan against focal segmental glomerulosclerosis (FSGS), investor appetite grows ever sharper for prospects in kidney disease.
Arcus Biosciences Inc., in a presentation on the opening day of the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), reported a 41% objective response rate across the first four cohorts in its phase I dose-escalation study of AB-680, a small-molecule CD73 inhibitor for treating metastatic pancreatic cancer. The data also showed 88% of patients experienced at least some shrinkage of their lesions.
Medtronic plc reported that the first patient has been enrolled in the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) study its trial evaluating the safety and efficacy of adaptive deep brain stimulation (aDBS) in patients with Parkinson's disease (PD). This type of stimulation is an investigational feature of the Percept PC device that could be enabled if approved.
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