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 ...
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 ...
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for a variation in licence for Pfizer-BioNTech’s 30 micrograms dose of Comirnaty XBB.1.5, a Covid-19 vaccine targeting the Omicron variant. The decision follows the vaccine’s fulfilment of the UK regulator’s safety, quality and effectiveness standards. The latest approval for the single-dose vials allows for the vaccine’s thawing and re-labelling by an authorised manufacturer outside of the UK’s National Health Service (NHS), adhering to good manufacturing practice standards. The NHS previously managed the thawing and distribution of the Comirnaty Omicron XBB.1.5 vaccine centrally. The vaccine requires ultra-low temperature storage at -80°C before it is thawed for usage. MHRA noted that the formulation of the Comirnaty vaccine, approved in September 2023, remains unchanged. The new authorisation by the MHRA is applicable only in Great Britain. The UK regulator also approved Novavax’s Nuvaxovid, an adapted vaccine targeting the Omicron XBB 1.5 ...
AstraZeneca has reported a significant 81% rise in profit after tax, reaching $5.96bn for the fiscal year (FY) 2023 from $3.29bn in the previous year. Despite a $3.73m decline in the sales of Covid-19 medicines, the company’s total revenue for the full year 2023 grew by 6% to $45.81bn, up from $44.35bn in FY 2022. Excluding Covid-19 medicines, AstraZeneca saw a 15% increase in total revenue. The company experienced growth across oncology, where revenues rose by 21%, cardiovascular, renal and metabolism (a rise of 18%), respiratory and immunology (a rise of 10%) and rare disease (a rise of 12%). Reported earnings per share (EPS) stood at $3.84, an 81% increase from the $2.12 reported in the previous year. Core EPS, a key profitability measure, rose 15% to $7.26. The company’s earnings before interest, taxes, depreciation and amortisation also saw a notable increase of 47% ...
Dopamine neuron senescence is a hallmark of Parkinson’s disease Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center and Columbia University Vagelos College of Physicians and Surgeons have reported that SARS-CoV-2 can infect dopamine neurones in the brain, triggering senescence. Long COVID patients should be monitored for an increased risk of developing Parkinson’s disease (PD)-related symptoms, as dopamine neuron senescence is a hallmark of the condition. The study revealed that dopamine neurons that are infected with SARS-CoV-2, the virus that causes COVID-19, stop working and send out chemical signals that cause inflammation, triggering senescence, when a cell loses the ability to grow and divide. Neurons produce dopamine, a neurotransmitter that acts on areas of the brain and causes feelings of pleasure, motivation, memory, sleep and movement. Damage to these neurons is also associated with PD, a neurodegenerative disorder that progressively damages parts of the brain. After generating multiple cell types from ...
Individuals suffering from urinary tract infections (UTIs) face the risk of continued pain and discomfort, chronic infections, kidney infections, and in severe cases, sepsis. This makes timely and accurate diagnosis of UTIs crucial. Now, a novel multiplexed PCR test capable of detecting 26 pathogens and 12 antibiotic resistance gene markers can assist clinicians in administering rapid UTI treatment. PathogenDx (Scottsdale, AZ, US) has launched D3 Array-UTI which is based on the company’s patented Dynamic Dimensional Detection (D3 Array) technology. This cutting-edge multiplexed molecular diagnostics technology offers triple-redundant testing for quality assurance and provides both qualitative as well as quantitative results in a single reaction. Additionally, it offers automated, cloud-based data analysis, reporting, and management. PathogenDx’s advanced microarray testing platform is designed for human diagnostics (for research use only), as well as for the food and agricultural industries. It can rapidly detect and identify up to 50 pathogens simultaneously in a ...
Stalicla announced the successful closing of a $17.4m Series B funding round as deal-making interest stirs in the central nervous system disorder space. “In the current environment, we see this [financing round] as a huge success, but we’re targeting a much larger round in Q3 2024 with the involvement of large venture capital funds,” says Stalicla CEO Lynn Durham in an exclusive interview with Pharmaceutical Technology. Stalicla aims to use the extra funds to launch a Phase III substance use disorder (SUD) study for its STP7 mGluR5 Negative Allosteric Modulator (mGluR5 NAM) platform in 2025. The US National Institute on Drug Abuse and the National Institutes of Health are supporting Stalicla’s development of STP7.Stalicla acquired the therapy through an in-licensing agreement with Novartis in January 2023. In this deal, the Swiss company acquired the worldwide rights for studies using the STP7 platform for SUD, neurodevelopmental disorders, and other indications in ...
Barrett’s esophagus is a condition often resulting from reflux, characterized by stomach acid damaging the esophagus lining and causing cell changes. While these cells aren’t initially cancerous, there’s a risk they might transform into esophageal cancer, a type where cells in the esophagus proliferate uncontrollably, potentially spreading to other body parts. Esophageal cancer is among the deadliest cancers in adults, and early detection significantly improves survival rates compared to a diagnosis at an advanced stage. Since the symptoms of esophageal cancer can mimic heartburn and reflux, conducting early tests for cancer detection is crucial. Now, a non-endoscopic capsule sponge device has been designed to collect pan-esophageal samples which are then sent for laboratory testing to detect esophageal pre-cancer and other conditions. Cyted’s (Cambridge, UK) EndoSign cell collection device is designed to detect and monitor conditions such as chronic reflux and Barrett’s esophagus, ultimately aiming to prevent esophageal adenocarcinoma. The EndoSign ...
AnaMar has received orphan drug designations for its systemic sclerosis candidate AM1476 from the FDA and the EMA. The Swedish biotech is now eligible for several incentives in the two regions, according to the designations. Both agencies will provide regular feedback during the application process and waive certain fees. The FDA also offers seven years of market exclusivity while the EMA promises ten years of protection from competition. AnaMar’s AM1476 is an oral antagonist of the 5-hydroxytryptamine receptor (5-HT2B) receptor, which is also known as a serotonin receptor. The company says its candidate halts key signalling pathways associated with fibrosis in a 5 February press release. Systemic sclerosis, also known as scleroderma, is a progressive autoimmune disease characterised by inflammation and fibrosis. Not only is skin hardened in this condition, but internal organs can be affected too. Interstitial lung disease (ILD) is one of the most common disease consequences, occurring ...
Mass spectrometry, known for its higher sensitivity and specificity compared to immunoassays, is particularly effective for testing molecules like Vitamin D and certain hormones where antibody-based tests struggle to differentiate between similar forms. This method allows for more precise testing. Researchers and clinicians have been investigating the use of mass spectrometry for such assays for several years. However, due to its complexity compared to standard immunoassays, mass spectrometry has largely been limited to large clinical reference laboratories and specialized testing companies that have the necessary resources and expertise to develop and conduct these tests. Now, a fully automated clinical mass spectrometry system being developed for routine lab testing could change that. Roche Diagnostics (Basel, Switzerland) is currently developing a fully automated, standardized liquid chromatography-mass spectrometry (LC-MS) solution that will seamlessly integrate into existing clinical chemistry and immunochemistry testing as part of its cobas Pro integrated solutions, as well as laboratory ...
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