PharmaFocus Today – Page 165 – media

Simple Blood Test Can Predict Heart Attack Risk within Six Months

Heart attacks are the leading cause of death globally, with their incidence on the rise. Despite this, many high-risk individuals either remain unidentified or fail to adhere to preventive treatments. Notably, the period preceding a heart attack is marked by significant biological changes. For instance, the risk of a heart attack doubles in the month following a divorce and increases fivefold in the week after a cancer diagnosis. Based on the hypothesis that several vital biological processes are active during the months before a heart attack, researchers have now suggested that these could be detected using a simple blood test. Researchers at Uppsala University (Uppsala, Sweden) have developed an online tool that, when used in conjunction with standard blood test results, can help clinicians determine if a person is at an elevated risk of experiencing a heart attack within the next six months. The study involved analyzing blood samples from ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294800241/simple-blood-test-can-predict-heart-attack-risk-within-six-months.html
- 160
- February 15, 2024
Hemogenyx gets reprieve as FDA lifts clinical hold on AML CAR-T therapy

Hemogenyx has received the all-clear from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial of its acute myeloid leukaemia (AML) chimeric antigen receptor (CAR) T-therapy in the US. In June 2023, the US FDA placed a clinical hold on the trial for HEMO-CAR-T, requesting additional information from Hemogenyx after a splicing deficiency during manufacture of the lentivirus used to produce CAR-T cells. Hemogenyx produced a plan, supported by laboratory tests to address FDA’s concerns in August 2023, which was accepted the following month. In January, the London, UK-based biopharma issued a complete response to the agency to lift the hold. Hemogenyx’s stock price has increased by 62% following the announcement of the lifting of the hold today (9 February) since the market close yesterday. CAR-T therapies have been hitting the headlines recently after the FDA launched an investigation into the incidence of potentially associated ...
- Source: https://www.pharmaceutical-technology.com/news/hemogenyx-gets-reprieve-as-fda-lifts-clinical-hold-on-aml-car-t-therapy/?cf-view
- 155
- February 15, 2024
International consortium identifies biomarkers for cardiovascular disease in diabetes

Type 2 diabetes is estimated to affect 462 million people worldwide An international academic consortium led by Johns Hopkins University, US, the Chinese University of Hong Kong and Lund University, Sweden, has identified 13 biomarkers that improve the ability to accurately predict the risk of cardiovascular disease in people with type 2 diabetes. The study was conducted by 23 experts across 11 countries as part of an international partnership between the American Diabetes Association and the European Association for the Study of Diabetes, the Precision Medicine in Diabetes Initiative. Estimated to affect around 462 million people globally, type 2 diabetes is a condition that causes too much sugar in the blood. Patients living with the condition are two times more likely to go on to develop cardiovascular disease compared to those without diabetes. Researchers reviewed and analysed the medical studies published from 1990 onward that investigated the differences between people ...
- Source: https://times.com/news/international-consortium-identifies-biomarkers-for-cardiovascular-disease-in-diabetes/
- 209
- February 15, 2024
Electrochemical Sensors with Next-Generation Coating Advances Precision Diagnostics at POC

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, ...
- Source: https://www.labmedica.com/clinical-chemistry/articles/294800220/electrochemical-sensors-with-next-generation-coating-advances-precision-diagnostics-at-poc.html
- 122
- February 14, 2024
FDA grants breakthrough status to J&J’s nipocalimab for HDFN

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Johnson & Johnson’s (J&J) nipocalimab for alloimmunised pregnant people at increased risk of increased severe haemolytic disease of the foetus and newborn (HDFN), which can cause life-threatening anaemia. This investigational therapy is the only one in the clinics for the condition, which occurs when the blood types of the pregnant individual and the foetus are incompatible. Nipocalimab is a fully human, aglycosylated, effectorless, monoclonal antibody designed to hinder the neonatal fragment crystallisable receptor (FcRn) and reduce levels of circulating immunoglobulin G antibodies. The regulator granted BTD based on findings from the proof-of-concept, open-label Phase II UNITY clinical trial of the therapy. The multicentre, international, non-blinded trial assessed nipocalimab’s efficacy, safety, pharmacodynamics and pharmacokinetics. The study met this primary endpoint with 54% of pregnant subjects. A small number of severe adverse events were reported in the study. ...
- Source: https://www.pharmaceutical-technology.com/news/fda-breakthrough-jj-nipocalimab/?cf-view
- 111
- February 14, 2024
Innovate UK grants funds for breast cancer therapy project

Innovate UK has awarded a £1m ($1.26m) grant for a collaborative initiative called AI-VISION to aid treatment decisions for breast cancer patients. The project involves the Institute of Cancer Research (ICR), Durham University, the Royal Marsden Hospital and techbio company Concr. It will support clinical decision-making, including directing breast cancer patients on the use of immunotherapy. AI-VISION is a 24-month observational clinical study to assess tissue samples from early triple-negative breast cancer (TNBC) patients. These subjects will be analysed to define and establish chemotherapy response biomarkers, irrespective of immunotherapy status. The study aims to validate the safety and performance of new computational methods to offer precision therapies for patients. Concr will apply Bayesian computational frameworks, inspired by astrophysics, to interconnect diverse oncology data, enabling researchers to detect and develop biomarkers indicative of drug response. The ICR will contribute genomic data from its genomics facility, which will be integrated with clinical ...
- Source: https://www.pharmaceutical-technology.com/news/innovate-uk-funds-breast-cancer/?cf-view
- 105
- February 14, 2024
NHS launches Pharmacy First to treat seven common conditions

Over 10,000 pharmacies in England will be offering the new advanced service The NHS has announced the launch of Pharmacy First, which allows patients in England to receive treatment for seven common conditions without needing to see a GP. Approximately 10,265 community pharmacies in England will be offering the new advanced service. From today, patients in England will be able to receive treatment for sinusitis, sore throat, earache, infected insect bite, impetigo, shingles and uncomplicated urinary tract infections in women under the age of 65 without needing a GP appointment or prescription. Community pharmacies play a vital role in keeping local communities in England healthy. The NHS has said that the new service will free up to ten million GP appointments by this winter. “This is all part of [a] major transformation in the way the NHS delivers care, [which will give] people more choice in how they can access ...
- Source: https://healthmedia.blog.gov.uk/2024/02/01/pharmacy-first-what-you-need-to-know/
- 115
- February 14, 2024
MRC Laboratory of Medical Sciences worth £120m opens on ICL campus

The institute is one of two UK laboratories wholly funded by the MRC The Medical Research Council (MRC) has opened a new Laboratory of Medical Sciences (LMS), worth £120m, at Imperial College Healthcare NHS Trust’s Hammersmith hospital. The institute is one of two laboratories in the UK that is wholly funded by the MRC. Commissioned by the LMS with investment from Imperial College London, the new eight-story building houses 400 scientists who work across themes including genes and the environment, heart and metabolic diseases and sex-based differences in diseases. It was designed to amplify the institute’s ability to bridge the gap between scientists exploring fundamental biological mechanisms as well as those translating that work into clinical applications. Professor Wiebke Arlt, LMS director, takes a new approach to research with a challenge-led team science approach, designed to build dynamic collaborations around specific biomedical challenges, co-designed with a variety of stakeholders such ...
- Source: https://pharmatimes.com/news/mrc-laboratory-of-medical-sciences-worth-120m-opens-on-icl-campus/
- 101
- February 14, 2024
Everly Health Partners With National Kidney Foundation, Expands Kidney Health Testing Suite

Everly Health is teaming up with the National Kidney Foundation to improve education around chronic kidney disease, the company announced Monday. In addition, Everly Health is also expanding its diabetes monitoring and kidney health testing suite for health plans and employers. Austin, Texas-based Everly Health is a digital health company for remote diagnostics and managing health conditions. It has three brands: Everlywell, which offers direct-to-consumer at-home health tests; Natalist, which offers fertility and pregnancy products; and Everly Health Solutions, which works with health plans and employers by providing at-home lab tests and virtual care to members and employees. Through the partnership between Everly Health and the National Kidney Foundation, the two organizations will have co-branded educational information about the importance of kidney health screening. Everly’s health plan customers will identify the patients who are at risk of chronic kidney disease, such as being diagnosed with diabetes. Everly Health will ship ...
- Source: https://medcitynews.com/2024/02/kidney-disease-home-testing/
- 99
- February 13, 2024
Why One Google Cloud Exec Thinks HHS’ New Cybersecurity Guidelines Are A Step In The Right Direction

Cyberattacks remain a formidable threat to healthcare providers, with hackers’ tactics getting more sophisticated by the day. Policymakers are trying to combat this. For example, New York Governor Kathy Hochul released a proposed set of cybersecurity regulations in November that require hospitals to establish new policies and procedures to protect themselves from ever-intensifying cyber threats. And a couple weeks ago, HHS published guidance outlining voluntary cybersecurity performance goals for the healthcare sector. While this initial guidance is voluntary, these goals will likely be used to inform upcoming HHS rulemaking. In its guidance, HHS outlined 10 key goals for strengthening providers’ cybersecurity: mandating basic cybersecurity training, mitigating known vulnerabilities, boosting email security, using multifactor authentication, ensuring strong encryption, requiring unique credentials, revoking credentials for departing workforce members, separating user and privileged accounts, establishing incident response plans, and vetting vendors’ cybersecurity. These guidelines are a starting point toward a more secure and ...
- Source: https://medcitynews.com/2024/02/google-cloud-hhs-cybersecurity/
- 104
- February 13, 2024

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