Researchers from University College London (UCL) have found that common routine blood tests could be used to speed up and improve early cancer diagnosis for patients in a new study published in PLOS Medicine. Researchers analysed data from more than 400,000 people aged 30 or older in the UK who had visited a GP due to stomach pain from the Clinical Practice Research Datalink, collected between 2007 and 2016, and from more than 50,000 who had visited their GP due to bloating – two-thirds of whom had blood tests following their appointment. The team found abnormal results in 19 commonly used blood tests were linked to a higher risk of being diagnosed with cancer within a year – one in 50 people who reported stomach pain, as well as bloating, to a GP were diagnosed with cancer within 12 months. If taken into account, researchers estimated that there would have ...
Pfizer has announced positive topline results from a pivotal late-stage study of its respiratory syncytial virus (RSV) vaccine, Abrysvo, in adults who are immunocompromised and at risk of developing severe RSV-associated lower respiratory tract disease (LRTD). As per the 12 August press release, Abrysvo was found to be well tolerated in the substudy B portion of the pivotal Phase III MONeT study (NCT05842967). While substudy B evaluated two 120 µg dose doses of Abrysvo, Pfizer reported that a single 120 µg dose of the vaccine led to “strong neutralizing” responses against RSV-A and RSV-B. The safety profile of Abrysvo was consistent with that of previous studies. “Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” said senior vice president and CSO, Vaccine ...
The US Food and Drug Administration (FDA) has approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD). Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease. Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products. The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release. Interchangeable biosimilars are eligible for a year of market exclusivity if they are the first biosimilar of a given product ...
Bronchopulmonary dysplasia (BPD) is a condition that impacts 65% of preterm infants, leading to chronic lung disease and neurodevelopmental impairments that persist throughout life. BPD typically arises when premature infants require respiratory support and prolonged oxygen therapy, which can damage their developing lungs. Currently, options for predicting, preventing, and treating BPD are inadequate. Diagnoses are often not confirmed until 36 weeks post-menstrual age, delaying interventions that could reduce lung damage and enhance respiratory health. Existing early prediction tools do not effectively address the underlying pathology of the disease. However, timely lung protective measures can modify BPD incidence. More precise care could be administered if the likelihood of lung damage and other complications in these infants were known sooner. Researchers have now developed a blood test that can predict which preterm infants will go on to develop chronic lung disease, facilitating earlier intervention and more focused treatment strategies. The research, led ...
By Don Tracy, Associate Editor Approval of neffy marks a significant advancement in epinephrine delivery, offering a less painful alternative to traditional needle injections.The FDA has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray), a first-in-class needle-free, nasal spray treatment for type I allergic reactions, such as anaphylaxis, for adults and children weighing 66 lbs. or more. According to the company, this approval offers a less painful alternative to traditional needle injections, which are often delayed due to anxiety, potentially worsening allergic reactions.1 “Until today, patients with severe allergic reactions, including anaphylaxis, only had one treatment option—an often painful and anxiety-inducing needle injection of epinephrine. In some cases, patients would delay or not administer the life-saving treatment at the onset of symptoms, increasing the risk for a severe reaction or negative outcomes requiring additional emergency medical treatment,” said Thomas B. Casale, MD, professor of medicine, pediatrics, and chief of clinical and ...
The US Food and Drug Administration (FDA) has approved ARS Pharmaceuticals‘ neffy (epinephrine nasal spray) 2mg for the emergency treatment of allergic reactions (type I). The indications include life-threatening anaphylaxis in adults and children weighing a minimum of 30kg. Previously, only injectable epinephrine was available for such patients. Anaphylaxis is a severe allergic reaction that can quickly become fatal, necessitating immediate medical intervention. Common triggers include certain foods, medications and insect stings, with symptoms such as hives, swelling, and difficulty breathing typically manifesting within minutes of exposure. The approval of neffy is supported by data from four clinical studies involving 175 healthy adults. These studies compared the blood concentration levels of epinephrine after administering neffy or traditional epinephrine injections. The findings indicated that neffy delivers comparable epinephrine levels to those of injectable products. In addition to matching the epinephrine blood concentrations, neffy demonstrated similar increases in blood pressure and heart ...
Sable Therapeutics has entered into an exclusive global licensing agreement with Columbia University to develop new polycation nanomedicines aimed at treating obesity. This partnership will focus on progressing a portfolio of compounds, SBL-001 and SBL-002, targeting both visceral and subcutaneous adiposity. Sable will hold sole rights for the development and commercialisation of the intellectual property created by Columbia University’s Dr Kam Leong, biomedical engineering professor Samuel Sheng, and Sable Therapeutics scientific co-founder Dr Li Qiang. SBL-001 and SBL-002 are designed to significantly diminish fat cell volume and have been uniquely engineered for selective uptake by adipose cells. Key features of the compounds include the ability to reduce fat cell targeted uptake volume by up to 70%. They can also act as a discrete drug delivery system for other agents, such as GLP-1s, which reduce fat. Sable Therapeutics focuses on creating assets for fat reduction, targeting conditions such as visceral obesity ...
Researchers from King’s College London have developed a new artificial intelligence (AI) brain imaging model in collaboration with University College London (UCL) which is realistic and accurate enough to use in medical research. Published in Nature Medicine Intelligence, the three-dimensional, synthetic images of the human brain could help support research to predict, diagnose and treat brain diseases including dementia, stroke and multiple sclerosis. According to Brain Research UK, there are an estimated 11 million people in the UK who are living with a neurological condition. Among the most common are Alzheimer’s disease, epilepsy and stroke. In collaboration with the London Medical Imaging and AI Centre for Value-Based Healthcare and NVIDIA data scientists and engineers, researchers trained the AI model in weeks as opposed to months using the NVIDIA Cambridge-1 supercomputer. The model is able to produce 3D, high-resolution images that have all the characteristics of real human brains, including correct ...
A US study supported by the Parkinson’s Foundation has revealed that genetic variants associated with Parkinson’s disease (PD) are more common than researchers previously thought. The PD GENEration study published in the journal Brain has been testing for clinically relevant PD-related genes while providing genetic counselling at no cost for people living with the condition since 2019, and recently reached a recruitment milestone of more than 15,000 patients. PD is a neurodegenerative condition in which parts of the brain become progressively damaged, causing problems such as shaking and stiffness. Results from the first 3.5 years of the study showed that 13% of patients have a genetic form of PD and revealed that positivity rates for a genetic variant were significantly higher for individuals at high risk of developing PD. Those with early-onset PD, high risk-ancestry such as Ashkenazi Jewish, Spanish Basque, or North African Berber, or with first-degree relatives affected ...
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in a phase 2 clinical trial (NCT06349980) of HLX53, an anti-TIGIT Fc fusion protein, in combination with HANSIZHUANG (serplulimab, HLX10) and HANBEITAI (bevacizumab, HLX04) for the first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC). Liver cancer is one of the most prevalent malignancy in the world. According to GLOBALCAN 2022, there are about 870,000 new cases diagnosed and 760,000 deaths for the tumour in the globe. Meanwhile, primary liver cancer (PLC) is the fifth most common cause and the second mortality cancer in China, with about 370,000 new cases and 320,000 deaths in 2022. From which, hepatocellular carcinoma (HCC) is the predominant pathological type of PLC, which accounts for between 75% and 85% of liver cancer cases. Due to its insidious onset, lack of symptom in its early stage, and quick progression, PLC usually has ...
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