A secondary analysis of two Phase 3 trials of Biogen's Alzheimer's disease drug Aduhelm showed more than 40% of patients with early Alzheimer's disease who took the drug experienced a side effect called amyloid-related imaging abnormalities. The most common side effect seen in the pooled data was ARIA-edema or swelling, followed by ARIA-microhemorrhage or microbleed, according to a study in JAMA Neurology.
The FDA has recommended several approaches to lower the risk of nitrosamine impurities in drug products. One of the strategies require manufacturers to consider using sodium carbonate and other antioxidants or excipients to inhibit the formation of nitrosamine impurities.
Mary Ruth Organics is recalling certain lots of organic liquid probiotics for infants after discovering the presence of Pseudomonas aeruginosa bacteria during internal testing. The California firm distributed the affected products nationwide.
Disinformation fueled in part by a politically connected activist group about experiments on beagles resulted in 3,600 angry phone calls -- many of them conveying threats -- in 36 hours to National Institute of Allergy and Infectious Diseases Director Anthony Fauci. The activist group, founded by a partisan political operative, capitalized on animosity toward Fauci over his stance on COVID-19 prevention measures to further its own agenda -- banning biomedical research involving animals -- and the group's leader defends the tactic of targeting Fauci personally.
A predictive analytics model that translates the electrical activity of animal cardiac cells into human-specific data could accelerate the development of new therapies for arrhythmia and other cardiac diseases, researchers reported in Science Advances. The researchers mapped the activity of mouse, rabbit and human heart muscle cells and developed systems for translating electrophysiological responses across species, which could be useful in studying the effects of drugs and heart disease.
Remdesivir, an antiviral approved by the FDA to treat COVID-19, was also effective against Ebola and Middle East respiratory syndrome in tests with rhesus monkeys and Nipah virus infection in African green monkeys, but the drug had some adverse effects in humans that were not seen in nonhuman primate studies. Researchers found that the drug is unstable in plasma, but a new study posted on bioRxiv discovered that encapsulating remdesivir in a polymer boosted the drug's stability among healthy rats and rats infected with SARS-CoV-2.
Sophisticated brain-computer interface devices could help people overcome paralysis, speech apraxia, depression and other maladies, but they must be found safe and effective with nonhuman primates before being tested in humans. Much of that research is being done in China, which has a vast nonhuman primate research infrastructure but whose animal welfare laws and intellectual property laws are less stringent than in the US.
Researchers in Japan have found a way to prevent barley from prematurely sprouting by making the genes for sprouting dormant. "We could successfully produce mutant barley that was resistant to pre-harvest sprouting, using the CRISPR-Cas9 technology," said Hiroshi Hisano, an associate professor at Okayama University.
Research published in JAMA Cardiology concludes that levels of apolipoprotein B predict the risk of heart attack in patients both with and without atherosclerosis better than other lipoprotein markers. The study found that levels of apolipoprotein B, non-HDL cholesterol, and triglycerides were all "predictive of risk when you look at them independently and without adjustment," but "apolipoprotein B was the only one that remained significant" when the presence of the other lipid markers was controlled for, said lead investigator Nicholas Marston, M.D.
An analysis of electronic health records of 8,592 patients with type 2 diabetes found that from 2012 to 2017, the number of people treated with statins decreased from 34% to 23% among women, and from 42% to 27% among men. The findings published in Scientific Reports also revealed that 8% of the participants who had high-stable, low-density lipoprotein cholesterol levels were the least likely to receive any moderate- and high-intensity treatment or any statin treatment.