PharmaFocus Today – Page 184 – media

Novel Nanoparticles Found in Blood Pave Way for Less Invasive Cancer Diagnosis

Extracellular vesicles (EVs) and exosomes, tiny nanoparticles about 1,000 times smaller than a human hair, are secreted by all cells into biofluids like blood and urine. These particles are known to transport genetic material safely through the body. Researchers have now discovered a new class of RNAs within EVs that could transform the diagnosis and treatment of cancer and other diseases. This team found that these RNAs change in the presence of cancer, indicating their potential as biomarkers for diseases like prostate cancer or as therapeutic targets. The research group at the Icahn School of Medicine at Mount Sinai (New York, NY, USA) has dubbed these RNAs “EV-UGRs” (Extracellular Vesicles-Associated Unannotated Genomic Regions), following their identification in the blood and urine of patients with prostate cancer. UGRs, often described as the genome’s “dark matter,” play a key role in gene regulation and protein synthesis. The team previously discovered that EVs ...
- Source: drugdu
- 441
- August 21, 2024
FDA Approves Incyte and Syndax Pharmaceuticals’ Niktimvo for Treating Chronic Graft-Versus-Host Disease

By Don Tracy, Associate Editor Approval of Niktimvo was based on positive data from the AGAVE-201 study, which demonstrated a 75% response rate in patients with chronic graft-versus-host disease.The FDA has approved Incyte Sundax Pharmaceuticals’ Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for treating chronic graft-versus-host disease (GVHD) in patients who have not responded to at least two previous lines of systemic therapy. According to both companies, Niktimvo is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD. The approval was based on promising results from the AGAVE-201 study.1 “With the approval of Niktimvo, patients with chronic GVHD whose disease has progressed after prior therapies, now have a new treatment option with a novel mechanism of action to help address the serious and devastating complications associated with this disease,” said Hervé Hoppenot, CEO, Incyte, in a press release. “Niktimvo is Incyte’s second approved treatment for ...
- Source: drugdu
- 180
- August 21, 2024
Digital Therapeutics Sector See Billing Codes as Key to Breaking Free of Reimbursement Rut

Medicare’s physician fee schedule includes billing codes for digital therapeutics for the first time. Stakeholders say these codes could help turn around reimbursement challenges weighing on the entire digital medicines sector. By Frank VinluanWhen the FDA approves a drug, passing that regulatory bar of safety and efficacy puts it on the path toward likely reimbursement by government and commercial payers. The same has not been true for digital therapeutics. A proposal from the Centers for Medicare and Medicaid Services signals a change in federal thinking about such technologies, which could pave the way for broader coverage of novel digital medicines. For the first time, CMS’s proposed physician fee schedule, a comprehensive annual listing of the fees that Medicare uses to pay doctors, now includes digital therapeutics. The proposal does not cover all digital therapeutics under multiple benefit categories, as the Digital Therapeutics Alliance (DTA) had asked nearly a year ago. ...
- Source: drugdu
- 280
- August 21, 2024
South African president calls on WHO for better mpox response

Amidst the global health emergency declared for mpox, the South African president has called for a greater emphasis on an equitable distribution of healthcare interventions. The World Health Organization (WHO), “must be different and correct the unfair treatment from the previous one [public health emergency] declared in 2022, where vaccines and therapeutics were developed and made available primarily to Western countries, with little support extended to Africa,” said Cyril Ramaphosa, the president of South Africa in a 17 August statement on the recent mpox outbreak in Africa. Ramaphosa called on the WHO to collaborate more closely with the Africa Centers for Disease Control and Prevention (Africa CDC) to allow wider access to vaccines, while countries in the African Union (AU) to increase domestic resource allocation. The AU is a continental union consisting of 55 African member states. Thus far, the AU has granted $10.4m in emergency funds to support Africa ...
- Source: drugdu
- 260
- August 21, 2024
Sound Pharmaceuticals plans to stick with WuXi amid BIOSECURE Act rumblings

Sound Pharmaceuticals wishes to maintain its relationship with the WuXi AppTec for manufacturing its lead Meniere’s disease drug SPI-1005, amidst increasing scrutiny on Chinese companies in the US, says CEO Jonathan Kil. In an exclusive interview with Pharmaceutical Technology Kil stated the company is “actively supporting WuXi”. The Biden administration set its sights on several Chinese firms with the introduction of the BIOSECURE Act, including WuXi AppTec. The BIOSECURE Act will withhold federal funding and contracts to companies should the biotech equipment or services used be sourced from ‘companies of concern’. These include several Chinese firms including WuXi. Under the Act, existing corporate ties will be permitted until 2032. According to Reuters, information stating the company transferred US intellectual property to Beijing without consent was shared with US senators driving this bill. Last month, Sound Pharmaceuticals completed a Phase III trial for its drug SPI-1005. Interim results from the study ...
- Source: drugdu
- 250
- August 21, 2024
New research reveals AI bowel cancer test can help patients avoid chemotherapy

A study led by researchers at the University of Leeds has revealed that a new artificial intelligence (AI) test to determine the risk of recurring bowel cancers could help patients avoid chemotherapy. The findings published in the Journal of Clinical Oncology Production could help doctors when deciding whether a patient needs chemotherapy following bowel cancer surgery. Found anywhere in the large bowel, bowel cancer is one of the most common cancers in the world, with 1.9 million cases diagnosed in 2020. In the UK alone, bowel cancer is the fourth most common cancer, affecting over 250,000 people. Researchers aimed to establish whether the number of CD3 cells within tumours could be used to predict the risk of a tumour coming back after surgery. In previous studies, bowel and rectal tumours with higher numbers of CD3 immune cells, which attack the cancer and help the body tackle the disease, have been ...
- Source: drugdu
- 212
- August 21, 2024
Researchers map interactions of 144 active substances to identify drug benefits

Researchers from the Technical University of Munich (TUM) have successfully mapped the interactions of over 100 active substances with around 8,000 proteins to help identify previously unknown benefits of existing drugs. Published in Nature Biotechnology, researchers yielded more than one million dose-responsive curves, which demonstrated the mechanism behind the effects of active substances over the course of treatment. Precision medicine is designed to optimise efficiency or therapeutic benefit for particular groups of patients using genetic or molecular profiling to provide patients with the most individualised treatment possible. To do this, a precise understanding of what is happening at the cellular level is required. Researchers treated cells with various doses of 144 active substances, most of which are already being used in cancer treatment or are in the clinical approval stage. Once extracted, the team analysed proteins using mass spectrometry before studying the cell reactions using the data. In cancer, depending ...
- Source: drugdu
- 218
- August 21, 2024
Novel Test Identifies Patients at High Risk of Esophageal Cancers

Barrett’s esophagus is a precancerous condition where chronic acid reflux damages the esophageal lining, increasing the risk of progressing to esophageal cancer or high-grade dysplasia. Currently, about 90% of patients with Barrett’s esophagus undergo endoscopic surveillance every three to five years. However, this frequency may not be sufficient to catch some cancerous changes early. It’s estimated that up to 25% of patients progress to high-grade dysplasia or esophageal cancer before their next scheduled endoscopy, missing crucial early treatment opportunities. Common treatments include radiofrequency ablation or endoscopic resection to eliminate abnormal cells before they turn cancerous. Now, a novel test could significantly aid gastroenterologists in identifying which patients with Barrett’s esophagus are more likely to develop esophageal cancer, thus optimizing surveillance and management strategies. This innovative test, named Esopredict, is a PCR-based test that evaluates DNA methylation changes in the genes RUNX3, p16, HPP1, and FBN1 from biopsy samples. DNA methylation ...
- Source: drugdu
- 225
- August 20, 2024
Mouthwash-Based Test Could Predict Head and Neck Cancer Recurrence

Head and neck cancers comprise close to 4% of all cancer cases in the U.S., predominantly affecting individuals over the age of 50. Men are over twice as likely to develop this type of cancer compared to women. The primary treatments, surgery and radiation, can severely impact functions such as speech, swallowing, and physical appearance, significantly diminishing the quality of life. These impacts can intensify with cancer recurrence, which is challenging to detect as it is hard to distinguish between normal post-treatment changes and a recurrence of the cancer. Early detection of recurrence could greatly reduce the severity of outcomes for patients. Now, a new test using a simple mouthwash to detect biomarkers shows promise in predicting disease recurrence in patients with head and neck cancer. A previous study by researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine (Miami, FL, USA) explored how ...
- Source: drugdu
- 157
- August 20, 2024
FDA Grants 510(k) Clearance to Cresilon’s Traumagel for Temporary External Control of Moderate to Severe Bleeding

By Don Tracy, Associate Editor Cresilon works to stop life-threatening bleeding in seconds, offering a valuable tool for military, emergency medical services, and healthcare professionals. The FDA has granted 510(k) clearance to Traumagel, Cresilon’s plant-based gel designed for temporary external control of moderate to severe bleeding. According to the company, the gel is expected to be a valuable tool for military, emergency medical services, and healthcare professionals. Additionally, Cresilon stated that Traumagel requires no preparation and is effective across all types of bleeds.1 “The ability to rapidly stop bleeding at the point of care and halt a life-threatening hemorrhage can be the difference between life and death for people with traumatic injuries,” said Joe Landolina, CEO, co-founder, Cresilon, inventor of the technology, in a press release. “The FDA clearance for Traumagel is a monumental milestone for Cresilon and brings us another step forward in our mission to save lives and ...
- Source: drugdu
- 198
- August 20, 2024

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