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 ...
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
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 ...
Researchers from University College London (UCL) and the Wellcome Sanger Institute have revealed how specific nasal cells differ in children and elderly people when protecting against COVID-19. Published in Nature Microbiology, the study used cells donated from healthy participants from Great Ormond Street Hospital, University College London Hospital and the Royal Free Hospital. Researchers focused on the early effects of the SARS-CoV-2 infections using the human nasal epithelial cells (NECs) gathered from children aged up to 11 years, adults aged 30 to 50 years, as well as elderly people aged over 70 years. After using specialised techniques to regrow these cells into the different types usually found in the nose, researchers used single-cell RNA sequencing to identify the genetic networks and functions of thousands of individual cells to identify 24 epithelial cell types. The cell cultures from each age group were then either mock-infected or infected with SARS-CoV-2. After three ...
Recently, Anhui ANKE Bio Engineering (Group) Co., Ltd (hereinafter referred to as “ANKE Bio”, stock code: 300009) signed a license agreement with Shanghai Shijian Biotechnology Co. (“ANKE Bio”). According to the license agreement, ANKE Bio has formally obtained the license of EZWi-Fit®, the ADC technology platform of SHIJIAN BIOLOGY, to develop ADC products. During the license period, ANKE Bio will be responsible for the preclinical research, clinical development and commercial production and sales of the developed products in Greater China, and will pay equity payments (including down payment and milestone payments) and a sales commission as a percentage of net sales to SHIJIAN BIO. Shijian Bio acquires an overseas interest in the ADC product. Shijian Bio is a clinical-stage ADC new drug discovery and development company with an ADC clinical pipeline and comprehensive new drug discovery and development capabilities, and has established a new-generation ADC technology platform, EZWi-Fit®, with its ...
Drugdu.com expert’s response: The approval process for import and export customs clearance permits typically involves the following steps: Application Preparation: Import and export companies prepare the necessary documents and information, including descriptions of goods, quantities, values, origins, destinations, as well as any required permits or certificates. Submission of Application: The application documents are submitted to the relevant import and export management department or agency. Applications can be submitted online or through traditional mail. Preliminary Review: The import and export management department conducts a preliminary review of the application documents to ensure completeness, accuracy, and compliance with relevant regulations and requirements. Approval: Following the preliminary review, further approval processes are carried out by the import and export management department. The specifics of the approval process depend on factors such as the type of goods, regulatory requirements in the country or region, etc. Issuance of Permit: If the application is approved, the ...
Small cell lung cancer (SCLC) is a highly aggressive type of cancer known for its ability to metastasize. The behavior of tumors is largely governed by which genes are turned on, or transcribed, irrespective of whether mutations are present. Researchers have identified various signature patterns of gene activation in SCLC, and these subtypes dictate how the cancer responds to treatments and its specific vulnerabilities. There is a significant need for blood-based tests that can determine SCLC subtypes, track disease progression, recognize transformations into other types of lung cancer, and identify potential treatment targets, especially when standard biopsies are not feasible. Scientists have now made progress towards a liquid biopsy capable of distinguishing between multiple SCLC subtypes from blood samples. New research at Fred Hutch Cancer Center (Seattle, WA, USA) has revealed that big-picture patterns of DNA packaging, gene activation, and mutations may provide the information required to develop a blood-based ...
Dive Brief Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday. Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type. Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company. Dive Insight Heartmate devices take over the pumping function of the left ventricle, the ...
Sepsis is a life-threatening condition triggered by an extreme response of the body to an infection. It requires immediate medical intervention to prevent potential death or lasting damage. Delay in diagnosing patients with sepsis or septic shock is linked with heightened mortality and morbidity, emphasizing the critical need for prompt diagnosis to improve survival rates. Now, new research findings promise faster diagnosis and better outcomes for sepsis and septic shock patients. In the study led by Murdoch University (Perth, Australia), researchers successfully used blood plasma metabolic phenotyping to accurately diagnose sepsis or septic shock within an hour of collecting blood samples. This method marks a significant improvement over traditional pathogen culturing techniques, which may take days to yield results. According to the researchers, metabolic signatures were the key to the breakthrough. The study involved the analysis of blood plasma samples collected from 152 patients admitted to the Intensive Care Unit ...
The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder. A Neumora Therapeutics drug candidate addressing a promising and competitive target for schizophrenia has been placed under an FDA clinical hold after new preclinical data emerged showing convulsions in rabbits that received the experimental treatment. The Neumora drug, NMRA-266, began Phase 1 testing last November. The clinical hold announced Monday pauses the study, which had dosed about 30 healthy participants so far. Watertown, Massachusetts-based Neumora said no convulsions have been observed in any of the study participants. The company added that it is working with the FDA to resolve the clinical hold and will provide an update on the program’s status when new information becomes available. “We are ...
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