PharmaFocus Today – Page 156 – media

Touchlight joins forces with University of Liverpool for NSCLC vaccine

UK-based CDMO Touchlight has teamed up with the University of Liverpool, UK, to utilise its doggybone DNA (dbDNA) technology in for developing a personalised DNA vaccine for patients with non-small cell lung cancer (NSCLC), which will be assessed in a clinical trial. Touchlight’s dbDNA is a small, closed loop of DNA that is made in a lab using enzymes. This technique can speed up the drug development process by amplifying long and complex DNA sequences without traditional methods like bacterial fermentation. The term doggybone DNA refers to the structure of the synthesised DNA molecule, which resembles a bone with two loops at each end. The approach offers a way to make vaccines very quickly, especially for personalised treatments. In March 2023, Touchlight received a £14m ($17.7m) grant from the UK government for commercial scale manufacturing of the technology. A team at the University of Liverpool will use Touchlight’s dbDNA technology ...
- Source: drugdu
- 96
- April 9, 2024
AstraZeneca reports positive Phase III results for Imfinzi in small cell lung cancer

Though a recent Phase III trial failed to achieve its primary endpoint with Imfinzi (durvalumab) in a specific subset of non-small cell lung cancer (NSCLC), AstraZeneca has announced that another Phase III study evaluating the checkpoint inhibitor has demonstrated a survival benefit in patients with limited-state small cell lung cancer (LS-SCLC). As per the 5 April press release, Imfinzi monotherapy demonstrated statistically and clinically meaningful improvements across the study’s primary endpoints of overall survival (OS) and progression-free survival (PFS). Additionally, the safety profile of the Imfinzi remained consistent with previous findings. The randomised, double-blind, placebo-controlled Phase III ADRIATIC study (NCT03703297) is actively evaluating Imfinzi as both a monotherapy and as a combination therapy with AstraZeneca’s Imjudo (tremelimumab) for the treatment of patients with LS-SCLC who have not progressed following concurrent chemoradiotherapy (cCRT). The study enrolled a total of 730 patients who were randomly assigned to receive placebo or 1500mg Imfinzi, ...
- Source: drugdu
- 191
- April 9, 2024
Study reveals new aptamer targeting tool can detect early signs of motor neurone disease

Researchers from the University of Edinburgh and the University of Aberdeen have revealed that an aptamer (biological molecules) tool can successfully detect early signs of motor neurone disease (MND). Published in Acta Neuropathologica, the aptamer was collaboratively developed by scientists at the University of Edinburgh, the Instituto Italiano di Tecnologia, King’s College London and the Centre for Genomic Regulation in Spain. Currently affecting around 5,000 people in the UK, MND is a fatal, rapidly progressing neurological condition caused by the accumulation of proteins in the brain that clump together to gradually stop cells from working. The new method works to detect MND by targeting the protein association with the disease in brain tissue before the onset of symptoms. It uses small biological molecules to bind to protein clumps that accumulate in the brains of people living with MND. Funded by Target ALS, researchers from Edinburgh and Aberdeen discovered that the ...
- Source: drugdu
- 199
- April 9, 2024
KCL project receives £100,000 UK government funding to boost AI-assisted healthcare

A project being led by King’s College London (KCL) has received funding from the Department for Science, Innovation and Technology (DSIT) totalling £100,000 to create a platform to boost artificial intelligence (AI)-assisted healthcare for cancer diagnosis. The PharosAI project will develop a platform for AI researchers and companies to access cancer-related datasets to train AI in healthcare settings. One of 12 teams awarded as part of the DSIT’s Research Venture Catalyst Programme, the project will comprise researchers from KCL, Guy’s and St Thomas’s Trust, Bart’s Cancer Institute and Bart’s Health Trust. The platform will help researchers and companies develop, evaluate and deploy NHS-quality AI for cancer diagnosis, offering AI clinical evaluation, deployment, standards validation services and educational programmes. According to the project proposal, researchers aim to develop a data refinery sourced from over 50,000 patient samples from King’s Health Partners Cancer Biobank and the Breast Cancer Now Tissue Bank to ...
- Source: drugdu
- 123
- April 9, 2024
Amylyx Withdraws ALS Drug From Market; Restructuring Will Slash 70% of Staff

The voluntary removal of ALS drug Relyvrio from the market comes with a corporate restructuring that turns Amylyx Pharmaceuticals’ focus to other neurodegenerative diseases. But the company also has another ALS drug candidate set to begin clinical testing this year.Amylyx Pharmaceuticals is withdrawing its drug for amyotrophic lateral sclerosis from the market, a decision that comes a month after post-marketing clinical trial results showed the medication was no better than a placebo at treating the fatal neuromuscular disease. Starting Thursday, Relyvrio (known as Albrioza in Canada) will no longer be available for new patients, Amylyx said. But patients currently receiving the drug in the U.S. and Canada who, in consultation with their physicians, wish to stay on treatment may transition to a program that will provide the drug for free. The withdrawal of Relyvrio is voluntary. The drug received full FDA approval in 2022 based on results from a small ...
- Source: drugdu
- 103
- April 8, 2024
Johnson & Johnson Set to Acquire Shockwave Medical, Aiming to Strengthen Company’s MedTech Division

Don Tracy, Associate Editor The deal, which is worth approximately $13.1 billion, is part of J&J MedTech’s goal to expand into high-growth markets. Johnson & Johnson (J&J) announced that it has agreed to terms on acquiring Shockwave Medical, an intravascular lithotripsy (IVL) technology company focused on coronary artery disease (CAD) and peripheral artery disease. According to J&J, the deal is a part of its strategy to enhance the profile of its MedTech division, with an emphasis on the area of cardiovascular intervention. Shockwave Medical’s IVL technology is described as a minimally invasive treatment for calcified artery diseases that can also lead to reduced blood flow, pain, or heart attacks. Under terms of the deal, J&J is expected to acquire all outstanding shares of the company for $335.00 per share in cash.1 “Shockwave offers a truly differentiated opportunity to further enhance our leadership position in medtech, expand into additional high-growth segments, ...
- Source: drugdu
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- April 8, 2024
Beckman Coulter receives FDA warning letter

Dive Brief Beckman Coulter received a warning letter in March after inspectors found fault with quality practices at a facility that makes immunoassay analyzer instruments and tests. The Food and Drug Administration, which published the letter Tuesday, said Beckman failed to adequately establish procedures for risk analysis and other activities at a facility in Minnesota. Beckman Coulter responded to the observations in January and February 2024, but the FDA said the responses to specific problems were either inadequate or impossible to assess at this time. Dive Insight The warning letter names the DxI 9000 Access Immunoassay analyzer instrument system and assays as the device that is “adulterated” because of the compliance failings. Rainer Blair, CEO of Beckman’s parent company Danaher, singled out Dxl 9000 as a new product that is “enabling faster, more accurate patient diagnosis” on an earnings call in January. Beckman was a growth driver in the fourth ...
- Source: drugdu
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- April 8, 2024
Simple Blood Test Combined With Personalized Risk Model Improves Sepsis Diagnosis

Sepsis, a critical condition that arises from organ dysfunction due to severe infection, can progress to severe sepsis and septic shock, leading to multi-organ failure and increased mortality rates. The complexity of diagnosing sepsis stems from the absence of a definitive test, with current detection methods depending on broad-ranged biomarkers such as CRP, PCT, and lactate levels. The disease’s variability and the general approach of administering broad-spectrum antibiotics, antivirals, and antifungals underscore the urgency for more specific diagnostic and treatment strategies. New research to be presented at ECCMID 2024 highlights the success achieved by researchers in identifying distinct molecular signatures associated with the clinical signs of sepsis that could enable more accurate diagnosis and prognosis of the condition, as well as help design targeted therapies for patients who stand to benefit the most. In this study, researchers from Lund University (Lund, Sweden) analyzed plasma samples collected over a period of ...
- Source: drugdu
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- April 8, 2024
Legend Biotech’s “CARVYKTI®” was approved for second-line indications in the United States

Recently, Legend Biotech announced in Somerset, New Jersey, that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (cilta-cel) for the treatment of relapsed or refractory multiple myeloid(RRMM) patients who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), and are resistant to lenalidomide1. CARVYKTI® is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for second-line treatment of multiple myeloma patients, including CAR-T therapy, bispecific antibodies and antibody-drug conjugates (ADCs). The FDA’s approval is based on positive results from the CARTITUDE-4 study, which showed that compared with pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (PVd), DPd) these two standard treatment regimens, CARVYKTI® can significantly improve the progression-free survival (PFS) of adult patients with relapsed and lenalidomide-resistant multiple myeloma who have received first- to third-line treatment. This result has statistical and clinical significance. The approval ...
- Source: drugdu
- 133
- April 8, 2024
World Health Organization launches AI-powered digital health assistant for public health

The World Health Organization (WHO) has announced the launch of a generative artificial intelligence (AI)-powered digital health promoter prototype ahead of World Health Day on 7 April. Celebrated annually, World Health Day draws attention to a specific health topic of concern to people globally. This year’s theme, ‘My Health, My Right’, champions the right of everyone, everywhere to have access to quality health services, education and information. The Smart AI Resource Assistant for Health (SARAH) will comprise new language models and cutting-edge technology to engage users across major health topics, including healthy habits and mental health. SARAH aims to provide an additional tool for people to learn their rights to health, by supporting them in developing a better understanding of risk factors for some of the leading causes of death worldwide, including cancer, heart disease, lung disease and diabetes. In addition, the AI assistant can help individuals access up-to-date information ...
- Source: drugdu
- 139
- April 8, 2024

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