Warming the hand is an effective way to facilitate blood collection from a fingertip, yet off-the-shelf solutions often do not fulfill laboratory requirements. Now, a unique hand-warming technology has been specifically designed to enhance the collection of high-quality blood samples from the fingertip. The hand warmer designed to improve the collection of high-quality capillary blood samples has been developed by Babson Diagnostics (Austin, TX, USA) in collaboration with experts in biomedical engineering who study the impact of heat on the human body in the design of therapeutic devices. The Babson Hand Warmer is part of its BetterWay blood testing ecosystem, which combines Babson’s proprietary sample preparation and laboratory technologies with the BD MiniDraw Capillary Collection System. This system is the result of a strategic partnership between Babson and BD (Becton, Dickinson and Company, Franklin Lakes, NJ, USA). Slated for commercial release this year, BetterWay revolutionizes blood testing by requiring just ...
Mike Hollan BrandShield states that it has identified sites selling counterfeit versions of Wegovy and Ozempic, among other drugs. It’s important to always be careful whenever buying anything from a website, especially medication. In recent years, it’s become much more common for patients and other consumers to find online sources where they can directly access medications without having to visit a pharmacy. This provides clear benefits for patients, such as limiting the burden placed upon them and potentially helping to reduce the cost of some medications. As is the case with most things, however, there are also risks. A new report from Reuters details one company’s work to take down sites selling fake medications.1 Not surprisingly, a significant percentage of these sites were selling counterfeit weight-loss drugs, such as fake versions of Ozempic. The report does note, however, that the number of sites selling these counterfeit weight-loss drugs has significantly ...
Don Tracy, Associate Editor With a final decision expected next February, MenABCWY combines the protective elements of GSK’s existing vaccines to target the five primary serogroups of Neisseria meningitidis. GSK announced that the FDA has accepted for review an application for its five-in-one meningococcal vaccine MenABCWY. MenABCWY is a combination of GSK’s two existing vaccines, Bexsero and Menveo, and targets the five primary serogroups (A, B, C, W, and Y) of Neisseria meningitidis. These serogroups are credited with causing the majority of meningococcal disease (IMD) cases around the world. According to the company, a final decision is expected on February 14, 2025.1 “In the Phase III trial (NCT04502693), all primary endpoints were achieved for the MenABCWY vaccine candidate, including immunological non-inferiority to one dose of GSK’s Meningococcal Groups A,C,Y and W Vaccine, and non-inferior immune responses against 110 diverse MenB invasive strains (representing 95% of MenB strains circulating in the ...
Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride extended-release capsules, a medication used to treat high blood pressure in the American market due to failed dissolution specifications, informed USFDA in its latest Enforcement Report. The affected lot has been produced in India and is being recalled for “failed dissolution specifications”, the USFDA said. “Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study,” it noted. Glenmark initiated Class II recall of the drug across the US on March 26 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. https://www.business-standard.com/companies/news/glenmark-pharma-recalls-6-528-bottles-of-blood-pressure-drug-in-us-124041400116_1.html
Biopharmaceutical companies are regaining interest in metabolic dysfunction-associated steatohepatitis (MASH) innovator drug development. MASH innovator drugs witnessed over $2.5 billion increase in the total value of partnership deals from 2020 to 2024 year-to-date (YTD), with more than $2 billion forged in Q1 2024 alone, reveals GlobalData. MASH, previously known as nonalcoholic steatohepatitis (NASH), is a disease characteriSed by liver inflammation and damage caused by the accumulation of fat. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a small molecule THRB agonist, was the first drug approved by the FDA for MASH in March 2024. Alison Labya, Business Fundamentals Analyst at GlobalData, comments, “Interest in MASH has returned in light of the FDA approval of Madrigal’s Rezdiffra, as well as the success of GLP-1 obesity drugs and their potential efficacy in MASH, as demonstrated by Eli Lilly’s Zepbound (tirzepatide; also known as Mounjaro for type 2 diabetes) in its Phase II SYNERGY-NASH trial readout.” However, ...
Clinical-stage biotech Chemomab Therapeutics has announced the publication of a study highlighting that high serum CCL24 levels are linked to more severe forms of systemic sclerosis (SSc). SSc is a chronic autoimmune disease characterised by excessive collagen production, leading to thickening and hardening of the skin and various internal organs. Affecting the skin, blood vessels, muscles, and internal organs, the condition causes symptoms like joint pain, skin tightening, and organ dysfunction. The study, published in the Arthritis Care and Research journal and conducted at the University of Leeds in the UK, looked at 200 patients with SSc. It found that a quarter of them had high levels of CCL24 in their blood, even though they were receiving standard treatment. Higher CCL24 levels were linked to more severe forms of the condition, including worse skin problems and lung issues. Scientists identified that high CCL24 levels were predictive of lung problems worsening ...
Recently, Hengrui Pharmaceuticals and its subsidiary Shanghai Hengrui Pharmaceuticals Co., Ltd. received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, approving the company to conduct an open, multi-center Phase I clinical study on the safety, tolerability and pharmacokinetics of HRS8807 combined with dalsylate hydroxyethanesulfonate in ER-positive, HER2-negative metastatic or locally advanced breast cancer patients. Breast cancer is the most common malignant tumor worldwide. According to the Global Cancer Epidemiology Report 2024, breast cancer ranks first among female malignant tumors in terms of incidence and mortality, with approximately 2.31 million new cases of breast cancer and 670,000 deaths per year globally, ranking first in terms of incidence and mortality of female malignant tumors. Among all breast cancer patients, about 70% are ER-positive, and the guideline-recommended standard treatment is endocrine drugs combined with CDK4/6 inhibitors. In contrast, the new generation of oral selective estrogen receptor down-regulators (SERDs) ...
Infections from soil-transmitted helminths (STHs), commonly known as intestinal parasitic worms, are among the most widespread neglected tropical diseases and impose a significant health burden in low- and middle-income countries, particularly among school-aged children. These infections often lead to chronic health issues that can cause disability, social stigma, and for their substantial economic impacts on communities. STHs are notorious role in nutrient loss, which can contribute to neurocognitive impairments, stunted growth and development, and persistent fatigue in affected children. Additionally, these parasites are a major cause of morbidity and complications during pregnancy. The standard diagnostic method for STHs involves manual microscopy, which requires up to 10 minutes per slide and is hindered by a lack of skilled professionals and access to necessary equipment and lab infrastructure in highly affected regions. There is a pressing need for improved diagnostic techniques, particularly for detecting infections of mild intensity, to effectively manage and ...
Colon cancer, a relatively common but challenging disease to diagnose, requires confirmation through a colonoscopy or surgery. Recently, there has been a worrying increase in colon cancer rates among younger populations, heightening the need to understand more about the disease’s mechanisms and preventive measures. Fusobacterium nucleatum, a bacterium typically linked with dental plaque and gingivitis, is found more frequently in colon cancer tissues than in normal colon tissues, suggesting its involvement in cancer progression and its association with adverse outcomes after treatment. Now, researchers have identified a specific subtype of this bacterium that can migrate to the gut and proliferate within colorectal cancer tumors. The finding could help improve early screening methods for colorectal cancer by paving the way for a test to screen for the presence of this bacterium with a mouth swab or stool sample. In the study, a team of researchers at Fred Hutch Cancer Center (Seattle, ...
Eli Lilly drug tirzepatide, marketed as Zepbound for weight management, has results from two Phase 3 studies showing reductions in the breathing problems caused by obstructive sleep apnea. Lilly is now preparing regulatory submissions to add this indication to the drug’s label. By Frank Vinluan Sleep apnea could be the next new indication for an Eli Lilly drug that’s already a blockbuster seller in metabolic indications. The pharmaceutical giant has preliminary Phase 3 data showing that treatment with the drug reduced the breathing interruptions characteristic of the common sleep disorder. With the positive data in hand, Lilly said it is now planning for regulatory submissions seeking to expand the label of tirzepatide, which is marketed as Mounjaro for type 2 diabetes and as Zepbound for weight management. Those submissions are expected in the middle of this year. Obstructive sleep apnea (OSA) is the collapse or partial collapse of the upper ...
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