PharmaFocus Today – Page 53 – media

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
- 104
- 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
- 63
- 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
- 72
- 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
- 76
- 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
- 71
- 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
- 63
- August 20, 2024
FDA Authorizes First At-Home, OTC Diagnostic Test for Syphilis

NOWDiagnostics’ First to Know has FDA De Novo marketing authorization as a new test for syphilis. The at-home product needs only a single drop of blood to test for this sexually transmitted infection. By Frank VinluanSyphilis testing typically requires obtaining a blood sample and sending it to a lab. The wait for results ranges from hours to days. The FDA has authorized a new at-home syphilis test, a NOWDiagnostics product that yields results within 15 minutes. The FDA said Friday that its marketing authorization for the NOWDiagnostics test makes the kit the first at-home, over-the-counter test for syphilis. Springdale, Arkansas-based NOWDiagnostics, or NOWDx, will market its new syphilis test as First-to-Know. Syphilis is caused by a bacterium, Treponema pallidum. It’s treatable with antibiotics, such as penicillin. Untreated, syphilis infection can damage the heart and the brain. This infection can also cause blindness, deafness, and paralysis. Reports of this sexually transmitted ...
- Source: drugdu
- 98
- August 20, 2024
Pfizer and BioNTech’s Covid-19/flu combination vaccine falters in Phase III readout

Pfizer and BioNTech have announced that a Phase III trial studying their investigational combination mRNA vaccine for the treatment of influenza and Covid-19 has failed to meet one of its two primary endpoints. While the vaccine demonstrated a trend of higher responses in neutralising the influenza A strain compared to a licensed influenza vaccine, it failed to demonstrate non-inferiority against the influenza B strain in geometric mean titers (GMT) and seroconversion, as per a 16 August press release. Additionally, data indicated that the combination vaccine showed “comparable” responses for SARS-CoV-2 when compared to Pfizer’s licensed approved Covid-19 vaccine, Comirnaty (tozinameran). The randomised, parallel assignment Phase III study (NCT06178991) enrolled over 8,000 adults aged 18 to 64 years old to evaluate the safety, tolerability, and immunogenicity of a single dose of the combined vaccine for protection against influenza and Covid-19. No new safety signals were found in the Phase III study. ...
- Source: drugdu
- 71
- August 20, 2024
AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting

AstraZeneca’s Imfinzi (durvalumab) plus chemotherapy has secured US Food and Drug Administration (FDA) approval for non-small cell lung cancer (NSCLC) in the perioperative setting, just weeks after the agency called for an overhaul of perioperative lung cancer trials. This approval is for patients with resectable early-stage (IIA-IIIB) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated in the perioperative setting – a term that refers to the time before, during, and after surgery. In a 25 July meeting, the FDA’s Oncologic Drugs Advisory Committee (ODAC) raised concerns about the design of trials done in this setting. The Imfinzi approval is based on positive data from the Phase III AEGEAN study (NCT03800134), which showed that the perioperative use of the treatment reduced the risk of cancer returning, progressing, or causing death by 32% compared to using chemotherapy alone. ...
- Source: drugdu
- 74
- August 20, 2024
McMaster drug trial receives more than $6m to test smallpox vaccine against mpox

Researchers from McMaster University have received $6.7m from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Canadian Institutes of Health Research to assess the effectiveness of a smallpox vaccine in providing protection against mpox after post-exposure. Beginning in August, the Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial (SMART) will assess the effectiveness of the Bavarian Nordic smallpox vaccine, MVA-BN, in more than 1,500 participants in households with laboratory-confirmed mpox infection at sites in the Democratic Republic of Congo (DRC), Uganda and Nigeria. Mpox is a disease caused by infection with a virus known as the monkeypox virus, which is part of the same family as the virus that causes smallpox. Symptoms include fever and headache, as well as painful lesions. In some cases, the disease can lead to bronchopneumonia, sepsis, encephalitis, loss of vision and even death. In the DRC, between June 2023 and 2024, ...
- Source: drugdu
- 54
- August 20, 2024

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