Davy James Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy. The FDA has approved Bristol Myers Squibb’s and 2seventy bio’s Abecma (idecabtagene vicleucel) to treat adults with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy that included an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.1 The regulatory action expands the indication for Abecma to earlier lines of treatment in patients whose disease relapsed or became refractory following administration of the three primary treatment classes following two prior lines of therapy. “Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the ...
Diagonal Therapeutics develops agonist antibodies to treat rare cardiovascular conditions. Using artificial intelligence, the startup’s technology sorts through billions of antibody/receptor combinations to identify the ones that reactivate signaling pathways lost to disease.In a drug discovery career spanning more than two decades, Alex Lugovskoy has seen a lot of antibodies come and go. The vast majority of them work by inhibiting a cellular function. Lugovskoy, now the CEO of startup Diagonal Therapeutics, said he long hoped someone would come up with a way to develop antibodies that activate their targets. With each passing year, no one did. So he took up the challenge himself. Diagonal uses computational and experimental techniques to understand what happens when an antibody binds to a receptor and which binding combinations will yield the desired effect. After developing its platform for the past two years, the startup this past week pulled back the curtain on its ...
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 ...
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, ...
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 ...
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 ...
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 ...
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, ...
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 ...
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 ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.