A patient with type 1 diabetes has begun producing his own insulin after receiving a transplant of pancreatic cells.
For the first time in humans, these islet cells have been genetically edited so they wouldn’t be rejected by the patient, removing the need for immunosuppressant drugs.
Type 1 diabetes usually begins when the immune system mistakenly attacks the islet cells in the pancreas, which are responsible for producing insulin. The condition is usually managed with a careful diet and regular insulin injections, but an emerging treatment involves replacing the damaged islet cells with functional ones.
Fresh grapes contain a potent mix of over 1,600 compounds that benefit heart, brain, skin, and gut health. New evidence suggests they deserve official superfood recognition, with benefits even at the genetic level.
A new article appearing in the current issue of the peer-reviewed Journal of Agriculture and Food Chemistry explores the concept of “superfoods” and makes a case that fresh grapes have earned what should be a prominent position in the superfood family. The author, leading resveratrol and cancer researcher John M. Pezzuto, Ph.D., D.Sc., Dean of the College of Pharmacy and Health Sciences at Western New England University, brings forth an array of evidence to support his perspective on this issue.
As noted in the article, the term “superfood” is a common word without an official definition or established criteria. Mainstream superfoods are typically part of the Mediterranean Diet and generally rich in natural plant compounds that are beneficial to a person’s health. Pezzuto addresses the broader topic of superfoods in detail, then makes the scientific case for grapes, noting that fresh grapes are underplayed in this arena and often not included with mention of other similar foods, such as berries.
The US Food and Drug Administration (FDA) has approved Tonix Pharmaceuticals’ Tonmya (cyclobenzaprine HCl, formerly known as TNX-102 SL), a novel treatment form for fibromyalgia.1 The drug is now the first in a new category of non-opioid analgesics for fibromyalgia and the first new medication for this disorder in 15 years.
The FDA’s approval cited efficacy from 2 double-blind, randomized, placebo-controlled, phase 3 clinical trials of almost 1,000 patients that evaluated Tonmya as treatment for fibromyalgia. Across both phase 3 trials, Tonmya significantly reduced daily pain scores compared with placebo at the primary endpoint of 14 weeks. In these trials, a greater percentage of patients taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after 3 months, as compared with placebo. Across phase 3 clinical trials with over 1,400 patients evaluated, Tonmya was generally well tolerated. The most common adverse events (incidence ≥2%) included oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
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The US FDA has granted De Novo marketing authorization for ArteraAI Prostate (Artera, Los Altos, California), a novel artificial intelligence (AI)-powered risk-stratification tool for patients with nonmetastatic prostate cancer.
The authorization means the digital pathology software tool is recognized as an FDA-regulated Software as a Medical Device, Artera explained in a press release.
De Novo authorization provides a marketing pathway to classify low-or moderate-risk novel medical devices. The De Novo authorization for this specific test establishes a new product code category for future AI-powered digital pathology risk-stratification tools and enables implementation at the point of diagnosis at qualified US pathology labs, the company said.
The test analyzes digital pathology images from patients’ biopsy slides to predict long-term outcomes, such as 10-year risk for metastasis and mortality. This can help direct treatment decisions.
The FDA’s De Novo authorization for the tool establishes a new product code category for future AI-powered digital pathology risk-stratification tools.