PharmaFocus Today – Page 167 – media

New Analytical Tool Could Replace Traditional Biopsies with Liquid Biopsies for Disease Diagnosis

Biopsies are important clinical tools used to diagnose various diseases or monitor tissues for abnormal growth or transplant rejection. Typically, this involves removing tissue samples from the body for closer examination, which can be invasive depending on the tissue required. Researchers have developed a new analytical method that could enable the use of “liquid biopsies” as an alternative to traditional biopsies for certain patients or diseases. This new tool, developed by researchers from Vanderbilt University’s School of Medicine Basic Sciences (Nashville, TN, USA), is known as EV Fingerprinting, where EV stands for extracellular vesicles. EVs are membrane-bound particles filled with biologically active materials that play a crucial role in cell-cell communication in both health and disease. Although EVs have been studied since the 1980s, their origins and functions have not been fully defined. Research on EVs has intensified over the last two decades, revealing their involvement in processes such as ...
- Source: drugdu
- 171
- July 19, 2024
Early Detection of miRNAs in Maternal Blood Could Predict Preeclampsia

Preeclampsia (PE) significantly contributes to increased maternal morbidity and mortality globally, with notably high incidences in the United States where it impacts 2–8% of pregnancies. This condition often leads to premature births and subsequent health issues for infants. Now, a new study indicates that early detection of specific microRNAs (miRNAs) contained in vesicles could enable the prediction of preeclampsia in pregnant individuals before the appearance of clinical symptoms. Conducted by researchers at UCLA Health (Los Angeles, CA, USA), this study highlights the potential of a distinct set of miRNAs within extracellular vesicles (EVs)—small particles that facilitate cellular communication—as a noninvasive biomarker for preeclampsia. The analysis involved 33 participants, including a control group of seven non-pregnant women and a subgroup of 12 women with healthy pregnancies. The study also included 14 women exhibiting symptoms of preeclampsia, emphasizing early detection and prediction. Women with preeclampsia exhibited different levels of miRNAs in EVs ...
- Source: drugdu
- 166
- July 19, 2024
FDA Grants Fast Track Designation to Abdera Therapeutics’ Treatment for Extensive-Stage Small Cell Lung Cancer

By Don Tracy, Associate Editor The novel therapy, ABD-147, uses advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, a protein found on neuroendocrine tumors. The FDA has granted Fast Track Designation to Abdera Therapeutics’ ABD-147, a next-generation precision radiopharmaceutical therapy designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed following platinum-based chemotherapy. According to the company, ABD-147 implements advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, which is a protein commonly found on neuroendocrine tumors but rarely expressed on the surface of normal cells or tissues.1 “Aggressive neuroendocrine cancers such as SCLC carry a poor prognosis and new treatment options are urgently needed,” said Lori Lyons-Williams, president, CEO, Abdera Therapeutics, in a press release. “These cancers have the most aggressive clinical course of any type of pulmonary tumor and often rapidly metastasize to other parts of the body. We are ...
- Source: drugdu
- 260
- July 19, 2024
Roche Weighs In With Encouraging Early Clinical Data for Oral GLP-1 Drug

Roche reported its oral GLP-1 agonist led to an average 6.1% weight loss at four weeks, according to preliminary results from part of a Phase 1 study. The small molecule comes from Roche’s $2.7 billion acquisition of Carmot Therapeutics last year. By Frank VinluanRoche is a relative latecomer to GLP-1 metabolic disorder drugs, but an oral drug candidate that came as part of a $2.7 billion acquisition last year now has preliminary early-stage clinical data that keep the pharmaceutical giant in contention to bring patients a pill to tap into this increasingly popular mechanism for weight loss. The results reported Wednesday are from a Phase 1 test of CT-996, a once-daily pill designed to activate the GLP-1 receptor to treat type 2 diabetes and obesity. Roche said treatment of patients who are obese and do not have type 2 diabetes lost a placebo-adjusted average of 6.1% of body weight within ...
- Source: drugdu
- 182
- July 19, 2024
KCL leads first guidelines on immune monitoring for hard-to-treat blood cancer

Myelodysplastic syndromes are a group of blood cancers that currently affect more than 7,000 people in the UK King’s College London (KCL) has led the publication of first-in-their-kind guidelines that aim to standardise how clinicians measure the immune response of patients living with a hard-to-treat form of blood cancer. The new guidelines will help identify which patients could respond to certain types of therapies, as well as better categorise patients based on whether their immune response is autoimmune or autoinflammatory to determine the choice of therapy and clinical outcome. Affecting more than 7,000 people in the UK, myelodysplastic syndromes (MDS) are a group of blood cancers in which immature blood cells in the bone marrow do not mature or become healthy blood cells, causing them to die in the bone marrow or just after entering the bloodstream. Risks associated with MDS can include an increased likelihood of infections, anaemia, bleeding ...
- Source: drugdu
- 154
- July 19, 2024
Study finds Parkinson’s disease SLT more effective than one used in NHS

The progressive neurodegenerative condition affects around 153,000 people in the UK Researchers from the Universities of Nottingham and Birmingham have revealed that a new form of speech therapy was more effective than the speech and language therapy (SLT) currently used in the NHS for Parkinson’s disease (PD). Published in the British Medical Journal, the PD-COMM trial has been evaluating the effectiveness and cost-effectiveness of two forms of SLT for people living with the neurological disease who have self-reported problems with voice or speech. Affecting around 153,000 people in the UK, PD is a neurodegenerative condition in which parts of the brain become progressively damaged, causing problems such as shaking and stiffness. Due to changes in the brain in people with PD, movements in the muscles to generate speech become smaller and less forceful than before, leading to speech and communication problems. Carried out across the UK by NHS Speech and ...
- Source: drugdu
- 152
- July 19, 2024
German CDMO outlays $980m on GLP-1 manufacturing expansion

German contract development and manufacturing organisation (CDMO) Corden Pharma announced a €900m ($980m) investment to expand its diabetes drug manufacturing capabilities, as shortages persist around the world. The company declared that the investment would be used over the next three years to expand its peptide manufacturing capabilities at sites in Colorado, US, and Europe. The facilities will have a particular focus on GLP-1 peptide manufacturing, as the demand increases. In a 16 July press release, the company spoke of multiple long-term contracts worth more than €3bn with potential benefits. Last year, the company signed a major deal with Eli Lilly to manufacture the active pharmaceutical ingredient for its leading obesity drug Mounjaro (tirzepatide), as per a Reuters report. In January 2023, the company also shared the signing of a $1bn multi-year agreement to manufacture a large volume peptide with an undisclosed company. The latest investment will be used to construct ...
- Source: drugdu
- 170
- July 19, 2024
Revolution sets sights on Phase III trial for pan-RAS inhibitor

Revolution Medicine plans to kickstart a Phase III trial following positive data from a first-in-human study of its investigational KRAS inhibitor RMC-6236 in pancreatic cancer patients. In an investor deck released yesterday [15 July], the company outlined updated data from the Phase I trial (NCT05379985) that outlined responses from 127 patients with pancreatic ductal carcinoma (PDAC) who received between a dose of RMC-6236 ranging from 160mg to 300mg. Median progression-free survival was 8.1 months in patients with the KRAS G12X mutation, and 7.6 months in those who broadly have RAS-mutant tumours. Among participants who had at least three prior treatment regimens, the median progression-free survival was 4.2 months. Out of the 127 participants, 96% suffered from side effects. The most common were rashes, diarrhoea, nausea, and mouth sores. Those adverse events were deemed severe or medically significant in 28% of patients. The company had previously presented early Phase I data, ...
- Source: drugdu
- 158
- July 19, 2024
Innovative C. Difficile Diagnostic Test Provides Both GDH and Toxin Results within 30 Minutes

Clostridium difficile is a leading cause of hospital-acquired diarrhea and pseudomembranous colitis. Infections typically occur when antibiotics disrupt the normal gut flora. Toxigenic strains of C. difficile produce toxins A and B, which are responsible for the symptoms of the infection. Diagnosing C. difficile can be complex because it is possible to carry the bacteria without it producing disease-causing toxins. All strains of C. difficile produce glutamate dehydrogenase (GDH), making GDH testing a useful initial screen for the infection. However, additional tests are necessary since a GDH-positive result does not confirm if the strain is toxin-producing, which is necessary to determine if the patient has an active infection or is just a carrier. Now, a new test that provides results for both GDH and the toxins within approximately 30 minutes can help healthcare professionals accurately distinguish between active infection and colonization in a cost-effective and clinically relevant way. The C. ...
- Source: drugdu
- 159
- July 18, 2024
AI Identifies Drug-Resistant Typhoid-Like Infection from Microscopy Images within Hours

Antimicrobial resistance is becoming a serious global health concern, making many infections increasingly difficult to treat and limiting available treatment options. This escalation in resistance raises the concern of some infections soon becoming untreatable. A major challenge for healthcare providers is quickly distinguishing between organisms that respond to standard first-line drugs and those that are resistant. Traditional testing methods, which involve culturing bacteria, testing them against various antimicrobial agents, and either manual or machine analysis, can take several days. This delay often leads to the administration of ineffective drugs, which can cause more severe health issues and potentially contribute to the development of further drug resistance. Researchers have now demonstrated that artificial intelligence (AI) can significantly cut down the time needed to accurately diagnose drug-resistant infections. They have developed an algorithm capable of correctly identifying drug-resistant bacteria from microscopy images alone. In research published in Nature Communications, the team of ...
- Source: drugdu
- 138
- July 18, 2024

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