PharmaFocus Today – Page 81 – media

Verona scores FDA approval for Ohtuvayre as COPD maintenance therapy

The US Food and Drug Administration (FDA) has approved Verona Pharma’s Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is an inhaled dual inhibitor of phosphodiesterase 3 and phosphodiesterase 4 enzymes and has bronchodilator and non-steroidal anti-inflammatory effects. Verona plans to launch the therapy in Q3 this year. “With substantial funding of up to $650m secured, Verona Pharma is well-positioned to distribute Ohtuvayre in the US, ensuring its availability even beyond 2026,” said Asiyah Nawab, Pharma Analyst at GlobalData. The Ohtuvayre approval was based on the positive results from Phase III ENHANCE-1 and ENHANCE-2 trials (NCT04535986 and NCT04542057). The data from the pooled analysis of the studies showed significant improvements in the symptoms of COPD exacerbations, including dyspnea, breathlessness, cough, sputum, and chest symptoms, in patients with moderate to severe COPD. Ohtuvayre is expected to generate global sales of $1.1bn by 2029, ...
- Source: drugdu
- 86
- June 29, 2024
The Lancet sub-journal publishes clinical phase 1b/2 results of the next-generation CD20 antibody MIL62 in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma

Recently, eClinical Medicine, a sub-journal of The Lancet, published the results of a phase 1b/2 study of recombinant humanized monoclonal antibody MIL62 injection in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma, led by Prof. Yuankai Shi of Cancer Hospital, Chinese Academy of Medical Sciences. The study was designed to evaluate the efficacy and safety of MIL62 in combination with lenalidomide in the treatment of relapsed/refractory follicular lymphoma and marginal zone lymphoma. Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are common pathological subtypes of non-Hodgkin’s lymphoma (NHL) and are inert lymphomas. In China, FL accounts for about 8% of B-cell NHL, while MZL accounts for about 12%. Early progression in patients with inert lymphoma is directly related to poor prognosis, with approximately 20% of patients experiencing disease recurrence or progression within 24 months of diagnosis (POD24). These patients typically have a poor prognosis, ...
- Source: drugdu
- 105
- June 29, 2024
Scientists uncover new disease-driving mechanism to treat atheroschlerosis

Researchers from the University of Bristol have revealed a new disease-driving mechanism that could help treat the development of atherosclerosis. The new therapeutic, IMSET, is being developed by researchers at the Bristol Medical School: Translational Health Sciences (THS) and is being supported by funding through beLAB1407, one of Evotec’s global portfolio of BRIDGE partnerships. Affecting 42% of adults without heart disease, atherosclerosis is characterised by the build up of atherosclerotic plaques (fatty deposits) in the arteries, which can lead to heart attacks, strokes and peripheral arterial disease. When investigating how immune cells in the blood contribute to the creation of atherosclerotic plaques within the arteries, researchers found that these cells could exist in different forms, with particular types driving the development of the plaques. The discovery allowed researchers to identify a certain genetic target, known as IMSET, “which is a central regulator of their behaviour… [which] will allow us to ...
- Source: drugdu
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- June 29, 2024
Study shows cholesterol-lowering drug reduces diabetic retinopathy risk

A study conducted by Oxford Population Health has demonstrated that a cholesterol-lowering drug could help reduce the risk of eye disease in people living with diabetes. The Lowering Events in Non-proliferative retinopathy in Scotland (LENS) trial has been investigating the effect of fenofibrate on retinopathy in patients living with diabetes and early retinopathy. Estimated to affect around 415 million people worldwide, diabetes is a chronic, metabolic disease that is characterised by elevated levels of blood glucose, which can lead to serious damage to the heart, blood vessels, eyes, kidneys and nerves. Globally, the prevalence of diabetic retinopathy among diabetic patients is estimated to be 27%. As part of the national routine diabetic eye screening programme, the LENS trial compared the effects of fenofibrate with a placebo in 1,151 adults with type 1 or type 2 diabetes in Scotland who had early-to-moderate diabetic retinopathy. Sold under several brand names, including Tricor ...
- Source: drugdu
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- June 29, 2024
New Urine Test Improves Accuracy for Early Detection of Bladder Cancer in Patients with Hematuria

Blood in the urine, known as hematuria, is often one of the earliest signs of bladder cancer. Although cystoscopy is recommended for patients presenting with both microscopic and gross hematuria, the detection rate for bladder cancer in these patients varies widely from 2% to 20%, leading to many unnecessary procedures. Additionally, due to the invasive nature of cystoscopy and low patient compliance, many cases of hematuria, especially microhematuria, are not promptly examined, missing early detection opportunities. This often results in diagnoses at more advanced stages, increasing both physical and economic burdens. To address these challenges, researchers have developed a simplified DNA-based urine test to enhance the early detection accuracy of bladder cancer in patients with hematuria and reduce reliance on more invasive cystoscopies. The potential of aberrant DNA methylation as a diagnostic biomarker for various cancers, including bladder cancer, has been recognized for some time. Researchers from Genomictree, Inc. (Daejeon, ...
- Source: drugdu
- 93
- June 28, 2024
Customizable AI Tool Helps Pathologists Identify Diseased Cells

Pathologists are tasked with examining body fluids or tissues to diagnose diseases, a process that involves distinguishing rare disease-indicating cells from thousands of normal cells under a microscope. This skill requires extensive training. Artificial intelligence (AI) can assist by learning to differentiate between healthy and diseased cells from digital pathology images. However, traditional AI tools, once trained, lack flexibility. They are designed for specific tasks, such as identifying cancer cells in one organ but not another, and might not align perfectly with a pathologist’s specific needs in different scenarios. Now, a collaborative team of computer scientists and physicians has developed a new AI tool that not only identifies diseased cells but also adapts to a pathologist’s requirements. Developed at Stanford Medicine (Stanford, CA, USA), the tool, named nuclei.io, functions like a human assistant that evolves with feedback. Starting with the basic function of recognizing different cell types by their nuclei, ...
- Source: drugdu
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- June 28, 2024
FDA Accepts Otsuka and Lundbeck’s Supplemental New Drug Application for Brexpiprazole to Treat Adults with Post-Traumatic Stress Disorder

Don Tracy, Associate Editor Results from three randomized clinical trials show safety and efficacy of a brexpiprazole-sertraline combination in adult patients with post-traumatic stress disorder. The FDA has accepted Otsuka and Lunbdeck’s supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The sNDA is supported by data from three randomized clinical trials that evaluated the safety and efficacy of the brexpiprazole-sertraline combination in adult patients with PTSD.1 “[PTSD] is one of the most common mental health disorders in the United States. Approximately 13 million adults in the US have PTSD during a given year, and between seven to eight out of every 100 will experience PTSD at some point in their lives,” said John Kraus, MD, PhD, EVP, chief medical officer, Otsuka, in a press release. “This is a significant development, and we look forward to continuing our efforts ...
- Source: drugdu
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- June 28, 2024
Novo Nordisk Drug Fails Pivotal Test in Hypertension and Chronic Kidney Disease

The Phase 3 results for ocedurenone come less than nine months after Novo Nordisk acquired the drug from KBP Biosciences. Novo Nordisk has stopped the clinical trial in uncontrolled hypertension and chronic kidney disease, but is evaluating potential applications of the small molecule in other indications. By Frank VinluanA Novo Nordisk drug for hypertension and chronic kidney disease has failed a pivotal study, a setback to the Danish pharmaceutical giant’s effort to bring patients a new therapy with potential safety and efficacy advantages over currently approved medications in the drug class, including a product marketed by Bayer. Novo Nordisk did not release specific details about the Phase 3 results for the drug, ocedurenone. The company said Wednesday that an independent data monitoring committee recommended stopping the trial after a prespecified interim analysis. Ocedurenone is a small molecule designed to block the mineralocorticoid receptor. When overactivated, this receptor can contribute to ...
- Source: drugdu
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- June 28, 2024
Lilly joins fellow pharma giants in OpenAI partnership

Eli Lilly has joined a growing list of pharma companies to partner with OpenAI, as it seeks to develop new treatments for drug-resistant pathogens. The collaboration will utilise the generative artificial intelligence (genAI) from OpenAI to come up with new solutions for microbial infections. Lilly didn’t specify the exact details of how OpenAI’s technology will be used, or any financial terms of the deal. Lilly joins Sanofi and Moderna, who have both unveiled partnerships with the genAI platform OpenAI this year. Last month, Sanofi announced that it was partnering with Formation Bio and OpenAI to harness AI to expedite drug development. On the other hand, Moderna has incorporated ChatGPT into an internal messaging platform called mChat, to harness data analytics, and use image generation, and dose selection. This new collaboration with OpenAI builds on Lilly’s commitment to tackle antimicrobial resistance (AMR). The pharma giant previously contributed $100m to the AMR ...
- Source: drugdu
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- June 28, 2024
GLP-1 shortages are not expected to resolve this year, says EMA Director

The glucagon-like peptide 1 (GLP-1) receptor agonists have emerged as blockbuster drugs and have raked in billions in sales. However, the higher demand for these therapies has now led to multiple reports of shortages. In response to these events, the European Medicines Agency (EMA) has put forth recommendations to tackle the shortages of these GLP-1 receptor agonists like Eli Lilly’s Trulicity (dulaglutide), and Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide) and Victoza (liraglutide). Another version of semaglutide, marketed as Wegovy, and Eli Lilly’s Mounjaro (tirzepatide) are approved in the EU for weight management in addition to diet and physical activity. The EMA has recommended that manufacturers and distributors avoid promotional activities for these products until the shortage persists. Cooke noted that EU member states should preserve stock, by controlling/limiting prescriptions. Broich stated that physicians should avoid prescribing GLP-1 receptor agonists for cosmetic use or in obese patients without any co-morbidities or ...
- Source: drugdu
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- June 28, 2024

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