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First of Its Kind Universal Tool to Revolutionize Sample Collection for Diagnostic Tests

The COVID pandemic has dramatically reshaped the perception of diagnostics. Post the pandemic, a groundbreaking device that combines sample collection and processing into a single, easy-to-use disposable unit could revolutionize the way samples are collected for diagnostic tests. ReadyGo Diagnostics’ (Bath, UK) Sampler device incorporates both the swab and collection buffers into one device, making it exceptionally user-friendly. It is the world’s first universal tool of its kind that ensures convenience, reliability, and reproducibility right from the initial step of a diagnostic test. The patented technology behind the ReadyGo Sampler uses specially engineered materials that not only allow the device to collect the exact amount of sample required instantly but also rapidly break open viruses and bacteria, making them readily detectable in specific tests. The ReadyGo Sampler device is intended to be a more user-oriented alternative to conventional swab-based sample collection methods by combining sample collection and processing into one ...
- Source: drugdu
- 83
- May 1, 2024
Blood Test Predicts Knee Osteoarthritis Eight Years Before Signs Appears On X-Rays

Osteoarthritis (OA) is the most prevalent form of arthritis, impacting millions worldwide and resulting in significant economic and social costs. Although no cure exists currently, the effectiveness of emerging therapies might depend on early detection and slowing the disease’s progression before severe debilitation occurs. Traditional diagnostic methods typically do not catch the disease until it has already caused structural damage to the joint. For example, an abnormal X-ray can reveal definitive signs of knee OA, but by the time these signs are visible, the disease has often been advancing for years. Now, a novel blood test has been developed that can predict the onset of knee OA at least eight years before its signs become visible on X-rays. Researchers at Duke Health (Durham, NC, USA) validated the accuracy of the blood test, which detects key biomarkers of OA. Their findings indicate that the test not only predicts the onset of ...
- Source: drugdu
- 116
- May 1, 2024
ETH Zurich researchers use AI to develop drug molecules based on protein structures

Researchers from ETH Zurich have developed a new generative artificial intelligence (AI)-based computer process to develop drug molecules based on a protein’s three-dimensional surface. The new process could revolutionise drug research, making it possible to generate active pharmaceutical ingredients quickly and easily. The new computer process’ algorithm was developed in collaboration with ETH’s professor Gisbert Schneider and former doctoral student Kenneth Atz, using AI to design new active pharmaceutical ingredients. Researchers trained the AI model with information from hundreds of thousands of known interactions between chemical molecules and the corresponding three-dimensional protein structures. The algorithm generates the blueprints for potential drug molecules that can increase or inhibit the activity of proteins with a known three-dimensional shape. The generative AI then designs molecules that bind specifically to the protein according to the lock-and-key principle to be interacted with. “This means that when designing a drug molecule, we can be sure that ...
- Source: drugdu
- 83
- May 1, 2024
KCL study reveals particles in cows’ milk effective for oral delivery of RNA drugs

In a new study, researchers from King’s College London (KCL) have revealed that tiny particles present in cows’ milk could offer a new and effective method for the oral delivery of ribonucleic acid (RNA) drugs. Published in the Journal of Nanobiotechnology, the tiny particles known as extracellular vesicles (EV) could help protect and deliver RNA drugs following oral administration. RNA therapies are a powerful class of drugs based on nucleic acids that offer a way to target previously untreatable diseases on a molecular level. Despite successful administration via injection, there has been no successful way to deliver them orally, as the drugs are destroyed by the harsh conditions of the gut. Researchers extracted EVs from cows’ milk and loaded them with RNA molecules to treat inflammatory bowel disease (IBD). EVs are nanoscale transporters that carry biological molecules in a protective coat throughout the body, controlling and regulating the access of ...
- Source: drugdu
- 107
- May 1, 2024
Study reveals high levels of antibiotic resistance in meat sold for consumption

New research presented at the ESCMID Global Congress (formerly ECCMID) in Barcelona, Spain (27-30 April) has found substantial levels of resistance to critically important antibiotics in meat sold for human and animal consumption. The study is by Dr Jordan Sealey, Professor Matthew Avison and colleagues from the University of Bristol, UK. Meat sold for consumption by humans and companion animals in the UK is regulated by the UK Government Food Standards Agency (FSA) to ensure it falls within bacterial limits deemed safe. However, while meat is tested for the types and amounts of pathogens present, it is not tested for resistant opportunistic pathogens (e.g. Escherichia coli). Multiple studies have shown a strong association between feeding dogs a diet of uncooked meat (raw dog food) and an increased risk of excreting E. coli resistant to critically important antibiotics in their faeces. It is possible that pet animals eating raw meat increases ...
- Source: drugdu
- 98
- April 30, 2024
Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’

The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the California biotech. (Jim Watson/AFP/Getty Images) After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. Gilead has cut the carrying value of Trodelvy to $3.5 billion in its first-quarter report, from $5.9 billion at the end of 2023, CFO Andrew Dickinson told investors during a call Thursday. The move comes after a January report of a phase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. The bad news at that time caused a 10% slide in Gilead’s stock price. The write-off reflects a “smaller addressable market that Trodelvy could serve among second-line-plus metastatic non-small cell lung ...
- Source: drugdu
- 129
- April 30, 2024
Pfizer scores FDA nod for hemophilia B gene therapy, will charge $3.5M per dose

Pfizer will offer a warranty program for its first FDA-approved gene therapy. The hemophilia B treatment will go for $3.5M, matching the price tag on CSL and uniQure’s hemophilia B gene therapy Hemgenix. (Pfizer) Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. The U.S. regulator has endorsed Beqvez (fidanacogene elaparvovec-dzkt) for adults with the bleeding disorder hemophilia B. It becomes the first FDA-approved gene therapy for Pfizer and the second in the indication following CSL and uniQure’s hemophilia B treatment Hemgenix, which became the world’s most expensive drug at $3.5 million when it was approved in 2022. Pfizer had the chance to undercut its rival on price but decided to charge the same $3.5 million for Beqvez. The therapy will be available to patients this quarter, a spokesperson confirmed on Friday ...
- Source: drugdu
- 88
- April 30, 2024
Fosun Pharma’s Self-developed Artemisinin Medicines Inject New Impetus to Malaria Prevention and Treatment in Africa

SHANGHAI, April 26, 2024 /PRNewswire/ — World Malaria Day is marked each year on April 25. World Health Organization (WHO) gave as the theme for World Malaria Day 2024 Accelerating the fight against malaria for a more equitable world. WHO stated that malaria not only continues to directly endanger health and cost lives, but it also perpetuates a vicious cycle of inequity. People living in the most vulnerable situations including pregnant women and children under 5 years of age continue to be disproportionately impacted. Artemisinin medicines developed with China’s scientific research efforts have become a ticket for China’s innovative medicines to go global. According to the WHO World Malaria Report 2023, globally in 2022, there were an estimated 249 million malaria cases and 608,000 malaria deaths. Sub-Saharan Africa accounted for more than 95% of the global malaria cases and deaths. Globally, an estimated 11.7 million malaria deaths were averted in ...
- Source: drugdu
- 74
- April 30, 2024
【EXPERT Q&A】What is the relationship between FDA registration and 510K registration for medical devices and what is the difference?

Drugdu.com expert’s response: The relationship between FDA registration and 510(k) clearance for medical devices involves overlap but also key distinctions. Relationship: 1.FDA Registration: This encompasses the process of submitting product information to the U.S. Food and Drug Administration (FDA) and obtaining FDA approval. It includes various types of registrations, such as 510(k) clearance, Premarket Approval (PMA), among others. 2.510(k) Clearance: This is a specific certification process within FDA’s regulatory framework, typically applicable to certain medical devices for which there are similar existing products on the market. In the 510(k) clearance process, manufacturers need to demonstrate that their product is substantially equivalent to an existing marketed device and does not pose an unreasonable risk to the user. Differences: 1.FDA registration is a broader concept encompassing various registration pathways, of which 510(k) clearance is one. 2.Within FDA registration, if a medical device can demonstrate substantial equivalence to a predicate device and meets ...
- Source: drugdu
- 177
- April 30, 2024
New CE-Marked Hepatitis Assays to Help Diagnose Infections Earlier

According to the World Health Organization (WHO), an estimated 354 million individuals globally are afflicted with chronic hepatitis B or C. These viruses are the leading causes of liver cirrhosis, liver cancer, and deaths related to viral hepatitis, affecting hundreds of millions. Early detection plays a crucial role in initiating timely treatments that improve long-term health outcomes. The detection of the hepatitis B virus surface antigen (HBsAg) in serum or plasma is an early indicator of infection. HBsAg is the first serological marker to appear in the progression of the disease, emerging in the blood two to three weeks before symptoms become apparent. Traditional testing protocols typically require retesting and subsequent confirmatory tests for reactive samples. Now, two newly introduced hepatitis assays use advanced technology to elevate efficiency and confidence in hepatitis testing. Beckman Coulter Diagnostics (Brea, CA, USA) has extended the menu of DxI 9000 Immunoassay Analyzer assays with ...
- Source: drugdu
- 123
- April 29, 2024

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