Cognoa has gained regulatory recognition for its machine learning software as a class II diagnostic medical device for autism — meaning the digital health startup is now positioned to submit an application for full FDA clearance.
Roche’s balovaptan has picked up a Breakthrough Therapy Designation in the US for its potential as a treatment for people with autism spectrum disorder (ASD), potentially placing the drug on a faster path to market.
An experimental Roche drug designed to improve social interaction in people with autism scored the U.S. Food and Drug Administration’s Breakthrough Therapy Designation.
Neurotech International Ltd has successfully raised $4 million via a placement of shares at $0.20 each to drive its ongoing commercialisation of the Mente Autism device.
In the current Chinese medical device industry, competition is extremely fierce, and many fields have become saturated, making it difficult to find new growth points or development space. But this set of data shows that there is a huge resource gap in the intervention of hearing loss in the elderly population in China. According to the “China Elderly Hearing Loss and Hearing Aid Application Survey” released by Tmall Health, Beijing Hearing Association, and Sonova Group, there is one professional hearing service provider for every 90000 people in China, which is much lower than the United States (9000:1). This huge gap not only reflects the scarcity of human resources allocation in this field in China, but also reflects the large scale of the population with hearing loss. 1. There are 120 million elderly people with hearing loss, and the wearing rate of hearing aids is less than 5% Hearing loss is ...
BioArt In the brains of mammals, in addition to a large number of neurons, there are also a large number of glial cells. These glial cells are widely involved in various aspects of advanced brain functions. Among them, astrocytes, as one of the most abundant glial cells in the mammalian brain, play a crucial role in the functioning of the brain, including participating in synaptic pruning, formation of the blood-brain barrier, and regulation of brain homeostasis balance. Moreover, an increasing number of studies indicate that astrocytes are directly involved in the processing of neural circuit information, and their developmental disorders may trigger various brain diseases. It is worth noting that the morphology and transcriptome characteristics of astrocytes exhibit high heterogeneity in different brain regions and even within the same brain region. During the development of the brain, the origin of astrocytes, namely the location of neural stem cells, determines the ...
Questions about whether acetaminophen use during pregnancy can lead children to develop neurological problems have sparked scientific inquiry and litigation. Lawsuits are continuing, but a new National Institutes of Health-sponsored study has results that show no causal link between acetaminophen and neurodevelopmental disorders. By Frank Vinluan When women experience pain or fever during pregnancy, many clinicians recommend acetaminophen for relief. But concerns about a possible link between these medicines and neurodevelopmental disorders have lingered. A multi-year study sponsored by the National Institutes of Health has results that add to the scientific consensus that these medicines aren’t the cause of neurodevelopmental problems. Acetaminophen is the active pharmaceutical ingredient in some prescription products and popular over-the-counter pain relievers, notably Tylenol and Excedrin. While nonsteroidal anti-inflammatory drugs offer an alternative approach to pain relief, these drugs aren’t recommended during pregnancy because they can cause low levels of amniotic fluid among other problems. The ...
The lack of non-invasive methods for monitoring brain status is a significant challenge in psychiatric care. Using genetic material from human blood and lab-grown brain cells, researchers have now made advances in developing a blood test to detect brain-related changes associated with postpartum depression and other psychiatric and neurological disorders. The research by investigators at Johns Hopkins Medicine (Baltimore, MD, USA) focused on tracing brain cell-derived mRNAs in the bloodstream. These extracellular vesicles (EVs), which are tiny sacs containing genetic material, are crucial for cell communication and carry messenger RNA (mRNA) from the brain. This method allows for the detection of changes in gene activity within the brain. The team’s interest in this area grew from an earlier study that found altered EV communication in pregnant women who developed postpartum depression after childbirth. The latest study used the human placenta as a model to identify 26 placental mRNAs in maternal ...
Stalicla announced the successful closing of a $17.4m Series B funding round as deal-making interest stirs in the central nervous system disorder space. “In the current environment, we see this [financing round] as a huge success, but we’re targeting a much larger round in Q3 2024 with the involvement of large venture capital funds,” says Stalicla CEO Lynn Durham in an exclusive interview with Pharmaceutical Technology. Stalicla aims to use the extra funds to launch a Phase III substance use disorder (SUD) study for its STP7 mGluR5 Negative Allosteric Modulator (mGluR5 NAM) platform in 2025. The US National Institute on Drug Abuse and the National Institutes of Health are supporting Stalicla’s development of STP7.Stalicla acquired the therapy through an in-licensing agreement with Novartis in January 2023. In this deal, the Swiss company acquired the worldwide rights for studies using the STP7 platform for SUD, neurodevelopmental disorders, and other indications in ...
Three years after bringing Jaguar Gene Therapy out of stealth, Deerfield Management is leading the funding of a manufacturing spinout from the Illinois company. Deerfield, with the help of ARCH Venture Partners and Nolan Capital, is backing a new company—Advanced Medicine Partners—which was formerly responsible for Jaguar’s chemistry, manufacturing and controls (CMC). The new firm seeks to provide best-in-class development of advanced medicines, including gene and cell therapies, addressing quality and scaling issues that have hindered new treatments. The management and technical teams have directed the CMC work of several approved products, including three gene therapies. In a release, CEO Andrew Knudten touted the experience of Advanced Medicine Partners’ genetic medicines team, which has manufactured roughly 350 non-GMP batches and supplied more than 20 preclinical studies. “With so many biotechnology companies being slowed or halted due to manufacturing challenges including product quality and scalability, we have the experienced people and ...
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