With many on Wall Street transfixed by the three injectable calcitonin gene-related peptide (CGRP) therapies cleared in the prophylactic migraine market, Satsuma Pharmaceuticals Inc.’s prospects with STS-101 may have gone overlooked, at least until lately.
Check-Cap Ltd., of Isfiya, Israel, reported positive results from a U.S. pilot study of its C-Scan System, a preparation-free, ingestible scanning capsule-based technology aimed at preventing colorectal cancer (CRC) through early detection of precancerous polyps. The company is currently preparing an IDE submission with the U.S. FDA and plans to launch a pivotal clinical trial in late 2020.
Genome sequencing is enabling new insights into the genetic aspects of health and disease that have touched just about every aspect in biomedicine. It is also, like the “skin”-colored crayons of yore, disproportionately focused on the Caucasian segment of the population. And that is a loss for everyone.
In the Dec. 20, 2019, issue of Science, Stefan Kaufmann, who is the founding director of the Max Planck Institute for Infection Biology, and his colleagues report that the immune system could calibrate its response to Pseudomonas aeruginosa by monitoring the bacterial quorum sensing chatter.
Will the digital transformation in health care start to benefit consumers in 2020? That was one of the challenges addressed in a recent report from PwC Health Research Institute titled “Top health industry issues of 2020: Will digital start to show an ROI?” The report predicts that in the next year, health system leaders will tout their investments in technology and transformation.
The screening of at-risk patients for Barrett’s esophagus, a precursor to esophageal cancer, has long been a goal for health systems. Currently, most patients with the condition remain undiagnosed, and more than 90% of individuals are identified after it has progressed into esophageal cancer via endoscopy, according to a 2018 paper in Digestive Diseases and Sciences.
The U.S. FDA’s attempt to use objective performance criteria for class II devices offers several advantages for device makers. However, the Advanced Medical Technology Association (Advamed) said in comments to the docket for two such sub-guidances that the documents are too narrowly scoped to be of much use in many instances.
Roseville, Calif.-based US Kidney Research Corp., formerly Curion Research Corp., has been working on its waterless renal replacement technology since its inception in June 2015. Its latest research efforts using its novel blood purifying technology have led to the production of the first ‘synthetic urine,’ which mimics the body’s natural production and the kidney’s filtration capability.
Researchers at Duke University have developed a bandage that concentrates adenosine at the site of a fracture and speeds bone repair. In animal testing, the bandage accelerated bone healing by 20% to 25%, lead researcher Shyni Varghese told BioWorld MedTech.
The exclusion of makers of devices and drugs from a proposed overhaul of the Anti-Kickback Statute (AKS) probably took many in industry by surprise, but Premier Inc., of Charlotte, N.C., argued that this approach fails to capitalize on an opportunity to hold manufacturers accountable for clinical outcomes in value-based arrangements.
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