Astellas Pharma is working with Kelonia Therapeutics, a startup that develops in vivo CAR T-therapies with technology that precisely delivers genetic cargo to cells. The collaboration combines this tech with a platform from Xyphos Biosciences, a cell therapy developer that Astellas acquired in 2019. By FRANK VINLUAN Cell therapy’s next breakthrough could be the engineering of these cells inside the patient. Two deals more than four years apart put Astellas Pharma in position to ramp up its work developing these in vivo treatments. Under the more recent agreement announced late Thursday, Astellas is collaborating with Kelonia Therapeutics, a startup that has developed technology for precisely delivering genetic cargo to target cells in the body in order to make those cells into in vivo CAR T-therapies. Kelonia calls its technology in vivo gene placement system, or iGPS. The genetic payload delivered to a cell gets it to express a receptor that ...
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that its Yellow Card Biobank will begin investigating a new group of medicines to prevent strokes. First launched in partnership with Genomics England in June 2023, the Yellow Card Biobank will help to improve understandings of how genetic makeup can impact the safety of medicines and to improve personalised medicine approaches. Accumulated genetic data and patient samples will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse drug reactions (ADRs), which involve medicines and medical devices. In total, ADRs account for one in 16 hospital admissions in the UK and continue to be a significant burden on the NHS. In its second phase, the genetic biobank will begin investigating direct oral anticoagulants, such as apixaban, dabigatran, edoxaban and rivaroxaban. A stroke, responsible for more than 100,000 cases in the UK every year, occurs when the ...
BHF data reveals early heart disease deaths rise to highest level In 2022, over 39,000 people in England died prematurely of cardiovascular conditions The British Heart Foundation (BHF) has revealed new data showing that early heart disease deaths in England have risen to the highest level seen since 2008. New figures show that over 39,000 people in England died prematurely of cardiovascular conditions, including heart attacks, coronary heart disease and stroke, in 2022. Cardiovascular disease is a general term for conditions that affect the heart or blood vessels in the body. In the UK, there are currently around 7.6 million people living with heart and circulatory diseases. Before 2012, the number and rate of deaths from these types of conditions among people under the age of 75 were falling. However, recent statistics have shown that the rate of premature deaths from cardiovascular disease has increased in England for three years. ...
CAD is responsible for around 68,000 deaths per year in the UK PlaqueTec and the Babraham Institute’s Flow Cytometry facility have announced a collaboration to develop and improve treatment for coronary artery disease (CAD). Both will develop a bespoke cell phenotyping assay for human blood to be used to analyse the blood of patients with CAD to catalogue cell types at the coronary disease sites. Responsible for around 68,000 deaths per year in the UK, CAD occurs when the arteries that supply blood to the heart are narrowed or blocked by atherosclerotic plaques. The Babraham Institute’s Flow Cytometry facility is currently one of the UK’s leading facilities, pioneering the latest flow cytometry technology and expertise. PlaqueTec aims to focus on understanding the biological mechanisms of CAD to advance the development of precision medicine. Current treatment approaches for CAD are general, as opposed to tailored for individuals, and can be ineffective ...
Dive Brief The Food and Drug Administration has categorized Smiths Medical’s correction of more than 50,000 syringe pumps in the U.S. as a Class I recall. Smiths Medical, which became part of ICU Medical in a $2.35 billion takeover in January 2022, wrote to customers in December after identifying software problems that could cause its Medfusion 4000 syringe pump to fail. There has been one reported injury linked to the problem. The recall is the latest in a series of regulatory actions related to Smiths Medical. ICU Medical was still working to resolve a warning letter sent to Smiths Medical in 2021 and was facing falling sales of acquired products as of Sept. 30, according to its most recent quarterly results filing. Dive Insight The Class I recall applies to Model 4000 syringe pumps distributed between November 2010 and July 2023. The devices are designed to administer fluids such as ...
Gonorrhea, ranked as the second most reported bacterial sexually transmitted infection (STI), affected approximately 82 million people globally in 2020. The infection can lead to severe health complications, including pelvic inflammatory disease, chronic pelvic pain, and infertility. Untreated gonorrhea may progress to the bloodstream, posing a life-threatening risk and increasing the likelihood of HIV infection. Many cases go unreported due to asymptomatic patients, implying that the actual burden of the disease may be significantly higher. Now, a rapid test aims to identify gonorrhea and also determine its antibiotic susceptibility. Visby Medical (San Jose, CA, USA) has been awarded up to USD 1.8 million by CARB-X (Boston, MA, USA) for the development of a portable rapid polymerase chain reaction (PCR) diagnostic to identify the presence of Neisseria gonorrhoeae (NG), the pathogen responsible for gonorrhea, and ascertain its susceptibility to ciprofloxacin. Ciprofloxacin was once a primary oral antibiotic for treating NG but ...
Globally, around 1.9 million people are diagnosed with colorectal cancer each year, resulting in approximately 935,000 deaths. Early detection is key, as colorectal cancer can be cured if found early. However, symptoms like weight loss or blood in the stool often emerge too late for effective intervention. Consequently, many countries have initiated population-based screening programs. These programs commonly utilize the fecal immunochemical test (FIT), which detects the blood protein hemoglobin in stool samples. Colorectal cancer screening programs have been effective in diagnosing the disease at earlier stages and reducing mortality rates. Despite the current test’s effectiveness, there is a need for improvement, particularly in detecting larger premalignant polyps before they become invasive. Early detection would allow for these polyps to be removed during a colonoscopy instead of requiring surgery. Researchers at the Netherlands Cancer Institute (Amsterdam, the Netherlandsl) have been developing a new test, the multitargetFIT-test (mtFIT), which measures hemoglobin ...
Drugdu.com expert’s response: The declaration of Class I medical devices as non-medical or medical depends on the specific use of the device and the regulations of the target market. Typically, Class I medical devices refer to low-risk medical equipment, such as surgical instruments and some diagnostic devices. In most cases, these devices are categorized as medical because they are used directly or indirectly for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases. However, if the same type of device is intended for non-medical purposes (for example, solely for cosmetic or personal care), it may be classified as non-medical. In such cases, the classification should be determined based on the actual use of the device and the regulations of the target market. Therefore, when declaring, you should consider the following factors: Purpose of the Device: Is the main use of the medical device for medical or non-medical purposes (such ...
Current point-of-care (POC) diagnostic technologies are typically limited to measuring a single disease biomarker or several biomarkers from the same class of molecules, such as various RNAs, proteins, or antibodies. However, the ability to measure multiple biomarkers from different molecular classes could provide a more comprehensive understanding of a disease’s state, severity, progression, and individual variations in its development. Electrochemical biosensors, which convert the chemical signal of a biomarker found in a small biofluid sample (like blood, saliva, or urine) into an electrical signal proportional to the biomarker’s amount, could potentially address many diagnostic challenges at the point of care. These sensors can be assembled into multiplexed arrays to detect different biomarkers, and recent advances have overcome the challenge of “biofouling” – the degradation of electrode surfaces by nonspecific biological molecules in samples – through the development of thin antifouling coatings. Now, researchers at Wyss Institute at Harvard University (Boston, ...
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