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NIH researchers gain new insights on rare immune deficiency

In an 11-year study, researchers at the National Institutes of Health have further characterized idiopathic CD4 lymphocytopenia (ICL), a rare immune deficiency that leaves people vulnerable to infectious diseases, autoimmune diseases and cancers. Researchers observed that people with the most severe cases of ICL had the highest risk of acquiring or developing several of the diseases associated with this immune deficiency. This study, published in the New England Journal of Medicine, was led by Irini Sereti M.D., M.H.S. and Andrea Lisco, M.D., Ph.D. of the HIV Pathogenesis Section in the Laboratory of Immunoregulation at the National Institute of Allergy and Infectious diseases (NIAID), part of NIH, and conducted at the NIH Clinical Center. ICL is a condition marked by too few CD4+ T-cells, which are a type of white blood cell. The clinical definition of ICL is a CD4+ T-cell count of less than 300 cells per cubic ...
- Source: drugdu
- 163
- May 6, 2023
Janssen signs $245m deal with Cellular Biomedicine for pair of CAR T-cell therapies

Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has entered into a worldwide collaboration and licensing agreement with Cellular Biomedicine Group (CBMG) for a pair of CAR T-cell therapy candidates. Under the terms of the agreement, Janssen will pay CBMG an upfront fee of $245m, with the Chinese biotech also eligible for certain milestone payments, as well as tiered royalties. In exchange, CBMG will grant Janssen a worldwide licence to develop and commercialise the CAR-T assets, except in Greater China, with the companies set to negotiate an option for the pharma to commercialise the products in the China territory. The investigational CAR-Ts have shown promising early-stage results in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL), the companies said, with the majority of patients in the studies having diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of aggressive lymphoma, accounting for approximately one-third of ...
- Source: drugdu
- 152
- May 6, 2023
Membrane lipid remodeling alters key enzyme involved in Alzheimer’s

Adding long-chain fatty acids can thicken cell membranes and alter the activity of a key enzyme, as LMU scientists have demonstrated in cell cultures. A characteristic feature of Alzheimer’s disease are deposits of the amyloid-β protein, which clumps together to form plaques in the brain. The amyloid-β protein is produced by an enzyme which resides in cellular membranes. A team lead by Prof. Harald Steiner and Dr. Edgar Dawkins from the Biomedical Center Munich at LMU has now shown that the production of amyloid-β is influenced by the membrane thickness. Cellular membranes consist of lipid bilayers. By externally adding further lipids, they can be thickened, which alters their properties. In earlier studies, Steiner’s team had already demonstrated in cell-free model systems that such changes affect the production of amyloid-β. This effect arises because the key enzyme for the production of amyloid-β, the so-called γ-secretase, is localized inside ...
- Source: drugdu
- 123
- May 6, 2023
Acelyrin follows Kenvue with largest IPO for a biotech startup since 2021

Acelyrin has raised $540 million in an initial public offering, the largest for a biotechnology startup since early 2021 and one of only a handful by young drugmakers this year. The company said Thursday it sold 30 million shares at $18 apiece, exceeding the projections it set earlier this week. It will start trading Friday on the Nasdaq under the ticker symbol “SLRN.” The pace of biotech IPOs has slowed considerably since 2021, when a record 104 startups flooded Wall Street, according to data compiled by BioPharma Dive. The following year, the number of new stock offerings fell by about 80%. Until this week, only five companies had priced a new offering in 2023, the sector’s slowest start in at least five years. The value of those offerings has also trended downwards. Prior to Acelyrin’s offering, nine of the last 15 biotech startups that went public raised $15 million or ...
- Source: drugdu
- 121
- May 6, 2023
Psychiatric disorders in children

Some types of epilepsy medicine taken during pregnancy are associated with an increased risk of severe psychiatric disorders in children. This is the conclusion of a comprehensive study of 38,000 children of mothers with epilepsy by researchers from Aarhus University. The research is published in the journal JAMA Neurology. While it has long been known that some forms of epilepsy medicine used during pregnancy are associated with a risk of birth defects, this new study is the most comprehensive study of children’s mental health so far. Among other things, the researchers found a worrying link between the antiseizure medication valproat and the child’s risk of developing a number of different psychiatric disorders. “Our study shows that four out of ten children born to mothers with epilepsy who had used valproat during pregnancy were diagnosed with a psychiatric disorder before the age of 18, and that the drug was particularly associated with an ...
- Source: drugdu
- 126
- May 6, 2023
FDA issues new draft guidance on decentralised clinical trials

The US Food and Drug Administration (FDA) has issued new draft guidance on the implementation of decentralised clinical trials (DCTs), in which some or all trial-related activities occur at locations other than traditional investigation sites. This could include carrying out clinical tests at a local facility rather than a research medical centre, or conducting follow-up visits in the participants’ homes using telemedicine. The 16-page document provides recommendations for sponsors, investigators and other stakeholders on the use of these trials, which the agency expects’ will play an important role in addressing public health needs’. ‘By reducing barriers to participation, we expect that DCTs will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges,’ the FDA said in a statement. The guidance covers recommendations on topics such as DCT design, the use of digital health technologies for remote patient monitoring, ...
- Source: drugdu
- 125
- May 6, 2023
BioSenic progresses cGvHD system and submits patent to EPO

Patent will allow the development of an industrial biomarker analysis kit which could be available worldwide. BioSenic – a company focusing on in autoimmune and inflammatory diseases – has announced that it has submitted a vital patent in relation to the use of its ATO platform. The patent is referred to as a ‘Diagnostic method for detecting the pathological correlates of chronic graft-versus-host disease (cGvHD) using particular cytokine or chemokine biomarkers’ and has duly been submitted to the European Patent Office desk for consideration. It also covers the use of a quantitative system of evaluating the impact of medications developed to change the course of cGvHD. Two years ago, BioSenic successfully concluded a national multi-location, single-arm phase 2 study in five university hospitals across France. During the trial, BioSenic treated 21 cGvHD patients with an intravenous formulation known as Arscimed. Subsequently, BioSenic published positive efficacy and safety results in the ...
- Source: drugdu
- 131
- May 6, 2023
Magic mushrooms may induce lasting improvements in color-blind vision

Researchers at the Department of Psychiatry and Psychology, Center for Behavioral Health, Neurological Institute at the Cleveland Clinic in Ohio have authored a case report on the positive effects of psilocybin on color blindness. Published in the journal Drug Science, Policy and Law, the researchers highlight some implications surrounding a single reported vision improvement self-study by a colleague and cite other previous reports, illustrating a need to understand better how these psychedelics could be used in therapeutic settings. Past reports have indicated that people with color vision deficiency (CVD), usually referred to as color blindness, experience better color vision after using lysergic acid diethylamide (LSD) or psilocybin (magic mushrooms). There is a lack of scientific evidence for these claims, as researching the effects of these drugs has been highly restricted. Color vision depends on a cluster of three types of photoreceptors known as cones—red, green, and blue sensing retinal photoreceptors with light-sensitive pigments. ...
- Source: drugdu
- 186
- May 6, 2023
New study reveals the best diets for a healthy heart

In a recent study published in the journal Vascular Health and Risk Management, researchers discuss the various non-traditional and traditional practices, as well as the socioeconomic and food insecurity-related limitations associated with adopting diets for heart health. Background Despite considerable progress in medicine and dietary interventions that have improved cardiovascular health, cardiovascular disease remains one of the most prevalent causes of mortality in the United States. Early studies on the association between diet and cardiovascular health reported that a diet rich in fish, vegetables, grains, fruits, and beans was linked to a lower rate of myocardial infarctions. Moreover, the consumption of vegetables and fruits, along with regular exercise, was associated with 40% lower rates of myocardial infarction. Hypertension, excess abdominal fat, dyslipidemia, and type 2 diabetes are some of the risk factors for cardiometabolic diseases that can be modified through changes in the diet. In the U.S., ...
- Source: drugdu
- 141
- May 5, 2023
Magic mushrooms may induce lasting improvements in color-blind vision

Researchers at the Department of Psychiatry and Psychology, Center for Behavioral Health, Neurological Institute at the Cleveland Clinic in Ohio have authored a case report on the positive effects of psilocybin on color blindness. Published in the journal Drug Science, Policy and Law, the researchers highlight some implications surrounding a single reported vision improvement self-study by a colleague and cite other previous reports, illustrating a need to understand better how these psychedelics could be used in therapeutic settings. Past reports have indicated that people with color vision deficiency (CVD), usually referred to as color blindness, experience better color vision after using lysergic acid diethylamide (LSD) or psilocybin (magic mushrooms). There is a lack of scientific evidence for these claims, as researching the effects of these drugs has been highly restricted. Color vision depends on a cluster of three types of photoreceptors known as cones—red, green, ...
- Source: drugdu
- 134
- May 5, 2023

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