Identifying biomarkers for various cancers and diseases often relies on cell-free DNA, RNA, and extracellular vesicles. Traditionally, separating blood plasma to detect these markers requires centrifugation, spinning blood to isolate cells from plasma. Yet, even after multiple centrifugation cycles, some cells and platelets remain in the blood plasma, potentially releasing unwanted biological materials that can affect diagnostic accuracy. Researchers have now developed a compact, coin-sized chip capable of extracting blood plasma directly from a sample within 30 minutes, resulting in a more convenient and user-friendly option than the currently laborious centrifugation method. The chip named ExoArc, developed by scientists at Nanyang Technological University (NTU, Singapore), offers a one-step solution to achieve over 99.9% purity by efficiently removing blood cells and platelets. This advance promises quicker and more reliable clinical analysis of critical biomarkers. To demonstrate its utility, the team developed a portable prototype device (measuring 30cm x 20cm x 30cm) ...
Rare kidney diseases are a group of conditions which account for over 5% of people living with chronic kidney disease A new study led by University College London (UCL) and the UK Kidney Association has suggested that treatments for rare diseases could significantly reduce the burden of kidney disease for patients and the NHS. Published in The Lancet in alignment with World Kidney Day (14 March 2024), the study draws on the largest kidney disease dataset ever created, the UK’s National Registry of Rare Kidney Disease (RaDaR). Affecting over seven million adults, according to Kidney Research UK, chronic kidney disease (CKD) is characterised by the gradual loss of kidney function over a period of months to years. Rare kidney diseases such as cystinosis and Fabry disease are a group of conditions that affect less than one in 2,000 people, accounting for over 5% of people with CKD. Researchers charted the ...
Davy James Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia. The FDA has granted accelerated approval to Takeda’s supplemental New Drug Application for Iclusig (ponatinib) plus chemotherapy to treat adults with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL).1,2 Iclusig is the only pan-mutational, third-generation tyrosine kinase inhibitor (TKI) that targets BCR::ABL1, an abnormal tyrosine kinase expressed in Ph-positive ALL and chronic myeloid leukemia (CML). Iclusig can also treat all known single, treatment-resistant mutations, including T315I. “This label expansion for Iclusig is an incredibly exciting milestone, allowing US adult patients with newly diagnosed Ph-positive ALL to have an approved, targeted treatment option in the frontline,” Awny Farajallah, MD, chief medical officer, oncology at Takeda, said in a press release. “We are thrilled that the FDA has recognized the potential of Iclusig to fill a large gap in care for these ...
Breathing in nontuberculous mycobacteria (NTM) is a common experience for many people. These bacteria are present in water systems, soil, and dust all over the world and usually don’t cause any problems. However, for individuals with certain underlying health conditions, these bacteria can lead to lung infections, showing symptoms similar to those of tuberculosis. Such infections can lead to chronic coughing, sometimes with blood, and scarring that increases susceptibility to respiratory infections like bronchitis and pneumonia. Diagnosing and treating these infections is a lengthy process due to the slow growth rate of the bacteria. With the number of NTM infection cases rising each year, partly due to climate change, there’s a pressing need for quick and precise diagnostic methods. Researchers have now introduced a CRISPR-based testing platform capable of identifying NTM infections using blood samples, providing results in as little as two hours. Researchers at Tulane University (New Orleans, LA, ...
Contineum Therapeutics, which emerged from a Verant Ventures startup creation engine, has filed paperwork for an IPO. The biotech’s clinical-stage pipeline spans multiple sclerosis, idiopathic pulmonary fibrosis, and depression. By FRANK VINLUAN Jhnson & Johnson is a partner on Contineum Therapeutics’ most advanced program, which is currently in mid-stage clinical testing for multiple sclerosis. As that research continues and Contineum plans to advance the development of its wholly owned assets, the biotech is moving forward with plans for an IPO. Contineum, which traces its origins to a startup creation engine of venture capital firm Versant Ventures, filed its IPO paperwork with the Securities and Exchange Commission late Friday. The company has not yet set any financial terms for its planned stock market debut, but IPO research firm Renaissance Capital said the offering could reach up to $150 million. The San Diego-based biotech has applied for a Nasdaq listing under the ...
AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug. By FRANK VINLUAN AstraZeneca is bolstering its rare disease pipeline with a deal to buy Amolyt Pharma, a biotech company in late-stage development with a therapy designed to treat a rare hormone deficiency whose only FDA-approved treatment will soon cease production. According to deal terms announced Thursday, AstraZeneca is paying Amolyt shareholders $800 million up front. Another $250 million is tied to the achievement of a regulatory milestone that was not disclosed. Considering that the drug is in Phase 3 testing, that milestone could be a regulatory approval. Lyon, France-based Amolyt is developing a therapy for hypoparathyroidism, a disease in which the parathyroid glands do not produce enough parathyroid hormone. This ...
The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence. By FRANK VINLUAN A chronic metabolic disease in which fat buildup leads to worsening liver function that can ultimately require an organ transplant now has its first FDA-approved therapy, a once-daily pill developed by Madrigal Pharmaceuticals. The FDA decision Thursday is for adults with noncirrhotic non-alcoholic steatohepatitis, or NASH. The approval specifically covers those who have reached the point of moderate-to-advanced liver scarring, which is also called fibrosis. The Conshohocken, Pennsylvania-based company’s drug, known in development as resmetirom, will be marketed under the brand name Rezdiffra. “We’ve had patients waiting and waiting for something that could impact underlying fibrosis in the setting of NASH, and this truly represents a milestone achievement that frankly I, and many ...
Melioidosis, a neglected tropical disease, is believed to affect around 165,000 individuals globally each year, with approximately 89,000 succumbing to it. This illness is caused by the bacterium Burkholderia pseudomallei, which thrives in the soil and water of tropical and subtropical areas, gaining entry into humans through skin cuts, consumption, or inhalation. Diagnosing melioidosis poses challenges due to its varying symptoms ranging from localized infections and pneumonia to severe septicemia or prolonged chronic conditions. The disease’s tendency to predominantly affect isolated rural communities contributes to its significant underreporting. Diagnosis traditionally depends on culturing bacterial specimens, a process extending over three to four days. Meanwhile, a large percentage of patients with melioidosis succumb to the disease, often within the initial 24 to 48 hours of hospital admission, while waiting for a diagnosis. Although no vaccine exists for melioidosis, it can be effectively managed with specific intravenous antibiotics if identified promptly. However, ...
The platform delivers digitalised patient data to improve clinical trials and development Phesi has announced that its artificial intelligence (AI)-driven Trial Accelerator platform has reached a critical milestone of now containing global data from more than 100 million patients. The volume will allow sponsors to access data on patients with over 4,000 indications, plan more successful trials and simulate clinical development activity more accurately. Phesi’s Trial Accelerator works to deliver digitalised patient data to enhance or replace those collected from clinical trials. Across the past two decades, data has been collated from product and disease registries, electronic health records, medical claims data and data gathered from around 100,000 dynamically updated sources. The platform powers the Phesi Patient Access Score, Diversity, Equity and Inclusion Data Service and the Digital Patient Profile. “We have been gathering and structuring a wealth of data for sponsors and clinical trial planners,” said Dr Gen Li, ...
Today, the U.S. Food and Drug Administration (FDA) announced it is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding will allow the agency to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s infrastructure and facilities. The request includes an increase of $495 million—or 7.4 percent above the FY 2023 funding level. The FDA’s request reflects the agency’s top priorities in key areas of importance for human and animal health. “The FDA continues to protect the health and well-being of millions of people,” said FDA Commissioner Robert M. Califf, M.D. “This new funding request will help us build on our accomplishments and also modernize our agency and operations as we plan for the future. Our request for critical investments will help us address our most urgent ...
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