Age-related macular degeneration (AMD) is still widely seen as the most common cause of irreversible blindness in those aged 50 and older, but the U.S. NIH and two partners from the private sector believe they have a solution. The three have teamed up to develop a patch embedded with induced pluripotent stem cells that has been implanted in a patient in the U.S. for the first time, marking the commencement of a safety study that may help take a bite out of the $4.6 billion in direct medical spending on AMD each year in the U.S.
Treating mice with butyrate, a short-chain fatty acid that is normally produced by beneficial gut microbes, prevented anaphylactic shock in allergic mice when they were exposed to peanuts after treatment. It also reduced inflammation in animals with colitis.
Cumulus Neuroscience Ltd. published a study demonstrating its home use electroencephalogram (EEG) can turn in more precise results than supervised laboratory-based assessments.
Regenerative medicine company Avita Medical Ltd. reported that topline results were mixed for its pivotal trial evaluating the safety and effectiveness of its Recell system combined with meshed autograft for reducing donor skin harvesting in soft tissue reconstructions.
Apollo Endosurgery Inc. released details of a landmark, multi-center randomized clinical trial demonstrating the safety and effectiveness of Apollo’s Endoscopic Sleeve Gastroplasty procedure (ESG) performed with the company’s endoscopic suturing system. The Merit study report comes on the heels of FDA market authorization of ESG as a minimally invasive, endoscopic weight loss therapy for patients suffering from obesity.
A study involving more than 1.25 million people in the U.S. has shown there is an increased risk of developing certain neurological and psychiatric conditions for up to two years after COVID-19 infection, and that despite causing less serious disease in the acute phase, the risk with omicron is the same as with the delta variant of SARS-CoV-2.
As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld.
The largest study to date assessing the use of cell-free DNA (cfDNA) analysis to detect cancer in advance of symptoms has completed enrollment of 140,000 healthy volunteers. The study, being run in the U.K. National Health Service (NHS) by the charity Cancer Research UK (CRUK) and cfDNA diagnostics specialist Grail Inc., is using Grail’s Galleri test to look for cancer-specific methylation patterns in blood.
Data on C2N Diagnostic LLC’s new blood test combining a proprietary p-tau217 measurement with the amyloid beta (a-beta) 42/40 ratio, a component of C2N’s commercially available PrecivityAD blood test, could help to predict people at risk for Alzheimer’s disease (AD) – even at the earliest stages.
Epigenetic test company Volitionrx Ltd. appointed contract research organization (CRO) Diagnostic Oncology CRO LLC (DXOCRO) to conduct development and clinical validation studies for its Nu.Q product portfolio in the U.S. DXOCRO will carry out large-scale finding studies across the U.S. using Henderson, Nev.-based Volition's cancer tests to determine clinical utility in sepsis and cancer. The trials are aimed at U.S. FDA approval of the products.
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