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FDA issues new draft guidance on decentralised clinical trials

The US Food and Drug Administration (FDA) has issued new draft guidance on the implementation of decentralised clinical trials (DCTs), in which some or all trial-related activities occur at locations other than traditional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
- 130
- 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
- 140
- 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
Wearable ultrasound researchers report breakthrough in deep tissue monitoring

This wearable ultrasound device for monitoring tissue stiffness measures 23 mm x 20 mm x 0.8 mm. [Photo courtesy of University of California San Diego] Wearable ultrasound researchers have developed a stretchable ultrasonic array for serial, noninvasive, 3-D tissue imaging with a penetration depth of up to 4 cm. The latest device out of Sheng Xu’s lab at the University of California San Diego (UCSD) is able to frequently evaluate the stiffness of human tissue. It could be used to measure the progression of cancer, to monitor muscles, tendons and ligaments, and assess the effectiveness of liver and cardiovascular treatments. Xu is commercializing the technology through a UCSD spinoff called Softsonics. “We integrated an array of ultrasound elements into a soft elastomer matrix and used wavy serpentine stretchable electrodes to connect these elements, enabling the device to conform to human ...
- Source: drugdu
- 136
- May 5, 2023
Algorithm generates 128-fold increase in antibodies

In a recent article published in the journal Nature, researchers used a classical concept in computational linguistics to design a new algorithm, LinearDesign, which optimized the structural stability and codon usage of messenger ribonucleic acid (mRNA) sequences. For instance, using this algorithm, researchers could optimize mRNA sequences encoding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein and use it in mRNA-based coronavirus disease 2019 (COVID-19) vaccines. Background All vaccines based on the relatively new mRNA technology suffer from common limitations, such as mRNA instability and rapid degeneration, which, in turn, lead to poor protein expression and, subsequently, compromised immunogenicity and druggability of all mRNA vaccine products. It also critically hinders the storage, distribution, and efficacy of all mRNA vaccines, including COVID-19 and varicella-zoster virus (VZV) vaccines. Therefore, there is an urgent need for a principled mRNA design algorithm that simultaneously optimizes stability and codon usage of encoding mRNA sequences to ...
- Source: drugdu
- 245
- May 5, 2023
Bristol Myers Squibb and Tubulis partner in deal worth over $1bn

The agreement is aimed at developing differentiated ADCs for solid tumours Bristol Myers Squibb (BMS) and Tubulis have announced an agreement aimed at developing differentiated antibody-drug conjugates (ADCs) for solid tumours. ADCs are a class of potent cancer therapies combining the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy ones. Under the terms of the licensing agreement, the German biotech will receive an upfront payment of $22.75m from BMS and will be eligible for future payments of over $1bn plus royalties. In exchange, BMS will gain exclusive rights to Tubulis’ Tubutecan payloads and P5 conjugation platform for the development of a selected number of highly differentiated ADCs to treat solid tumours. ...
- Source: drugdu
- 149
- May 5, 2023
ChatGPT outshines physicians in quality and empathy for online patient queries

By Neha Mathur In a recent study published in JAMA Internal Medicine, researchers evaluated the ability of ChatGPT, an artificial intelligence-based chatbot assistant, to respond to patient questions posted on a publically accessible social media forum. Background Owing to the quick expansion of digital health care, more and more patients have begun to raise queries on social media forums. Answering these questions is not just time-consuming but tedious for healthcare professionals. AI assistants, like ChatGPT, could help address this additional work and help draft quality responses, which later clinicians could review. About the study In the present cross-sectional study, researchers randomly drew 195 exchanges in response to a patient question asked over Reddit’s r/AskDocs, a publically accessible social media forum, in October 2022. Then, a team of licensed healthcare professionals generated a new chatbot session using the original full text of the question to which a physician responded and then evaluated the ...
- Source: drugdu
- 146
- May 5, 2023
Mpox outbreak was wake-up call for smallpox preparation, vaccine maker Bavarian Nordic says

The maker of the mpox vaccine is looking at ways to dramatically scale up its production capacity to prepare for a potential threat from smallpox. Bavarian Nordic CEO Paul Chaplin said the rapid spread of mpox last year was a wake-up call for the company, which is based in Denmark. “If it wasn’t mpox but it was smallpox, we are completely at the wrong scale,” Chaplin told CNBC in an interview. “We’re looking at ways we can dramatically change the way we manufacture to increase our scale,” he said. Mpox is in the same virus family as smallpox. Bavarian Nordic’s Jynneos vaccine is approved by the U.S. Food and Drug Administration to protect against both pathogens. Previously known as monkeypox, the World Health Organization changed the name to mpox last year to reduce stigma. Bavarian Nordic plans to simplify its production process so ...
- Source: drugdu
- 109
- May 5, 2023

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