At the World Health Organization’s (WHO) sixth meeting of the Intergovernmental Negotiating Body in Geneva, the WHO director-general Dr Tedros Adhanom Ghebreyesus has called out critics of the organisation’s planned pandemic accords at the opening remarks of Intergovernmental Negotiating Body’s sixth meeting. “20 years ago, the tobacco industry tried to undermine negotiations on the WHO Framework Convention on Tobacco Control. The same thing is happening now. Groups with vested interests are claiming falsely that the accord is a power grab by WHO, and that it will stymie innovation and research,” he said in his opening remarks on 19 July. The “Pandemic prevention, preparedness and response accord” is an agreement between the WHO member states to “draft and negotiate a convention, agreement or other international instrument under the Constitution of the World Health Organization to strengthen pandemic prevention, preparedness and response”. Member states began developing the pandemic accords in February 2022 ...
Dive Brief Abiomed’s Impella heart pumps can potentially interact with transcatheter aortic valve replacement (TAVR) stents, causing damage to the heart pump’s motor, the Food and Drug Administration said in a recall posted Friday. The company, which was acquired by Johnson & Johnson in December, began the recall of its Impella heart pumps in June, warning that the problem could result in low flow from the damaged pump or that the fractured material could block blood flow. Abiomed is not pulling the device from the market, but cautioned physicians to place it carefully in patients. Dive Insight The FDA marked the recall as Class I, its highest risk category. It did not specify whether any injuries or deaths had been reported. The recall includes Abiomed’s Impella CP with SmartAssist, Impella 5.5, Impella 5.0, Impella 2.5 and Impella LD pumps, totaling 9,252 units. ...
Why do nonsteroidal anti-inflammatory drugs (NSAIDs) exacerbate gastrointestinal infections by Clostridioides difficile, the leading cause of antibiotic-associated diarrhea worldwide? In a new paper published in Science Advances, researchers at Children’s Hospital of Philadelphia (CHOP) have begun to answer that question, showing that NSAIDs disrupt the mitochondria of cells lining the colon, sensitizing them to damage by pathogenic toxins. Clostridioides difficile, often referred to as C. difficile or C. diff, is a bacterium that leads to a wide range of symptoms, from mild diarrhea to complex infection and death. The factors that influence this wide spectrum of clinical outcomes remain largely unclear, but emerging evidence suggests that factors like diet and pharmaceutical drugs influence both susceptibility to infection and disease progression. However, researchers still know very little about how these factors impact the course of C. difficile infection. Prior studies have shown that NSAIDs like indomethacin, aspirin, and ...
Glioblastoma (histology slide). Credit: Wikipedia/CC BY-SA 3.0 “Don’t eat me,” is how one might translate the signal that the cancer cells in a glioblastoma send to the macrophages (white blood cells specialized in removing dead and dying cellular matter) in the brain. Immunotherapy attempts to enable these cells to eradicate the abnormal cells, but so far, it has met with little success when it comes to glioblastomas. Researchers led by Professor Gregor Hutter from the Department of Biomedicine at the University and University Hospital Basel have recently used patient data, experiments with mice, and samples from human tumors to study one of these “don’t eat me” signals and its inhibitory effect. Their findings, which may pave the way for effective immunotherapies for glioblastomas, are now being published in Science Translational Medicine. The signal is based on sugar molecules called sialic acid glycans on the surface of the cancer cells. These sugar molecules are ...
While vaccines for COVID-19 have certainly enjoyed the spotlight in recent years, rates of uptake for other shots have sharply declined.That’s the finding of a new analysis funded by GSK in collaboration with the IQVIA Institute for Human Data Science and the Global Coalition on Aging (GCOA). All told, about 100 million fewer doses than anticipated of some adult vaccines, other than those targeting COVID-19, were administered between 2021 and 2022, the team found. To reach this number, the group weighed vaccine use in the last two years versus trends in global vaccine adoption from 2013 to 2020. In fact, just 16.2 doses of some vaccines were doled out globally per 100 adults in 2022. Meanwhile, COVID-19 vaccines saw overwhelming success with 132 doses delivered for every 100 adults in the same year, according to the report. “While significant strides in vaccine development have delivered vaccines to ...
Dive Brief QuidelOrtho’s recall of a test to detect heart attacks was labeled Class I by the Food and Drug Administration, the most serious type of recall, the agency said in a Monday notice. The San Diego-based diagnostic manufacturer flagged a problem with the tests in late May after receiving reports that the tests showed lower than expected troponin levels, which could result in delayed or missed diagnosis of a heart attack. The recall affects nearly 7,800 tests, and QuidelOrtho is instructing clinicians to immediately discontinue using the product, and instead use a different test or send patients to another testing site. Dive Insight Quidel’s Triage Cardiac Panel is intended to help diagnose heart attacks. The test uses a blood sample, and can deliver results in about 20 minutes, according to the company’s website. It is important to detect heart attacks quickly to ...
Johnson & Johnson has hopped on the litigation bandwagon, becoming the fourth large drugmaker to sue the U.S. government over drug price negotiations in the Inflation Reduction Act (IRA).In U.S. District Court in New Jersey, J&J claimed (PDF) that price negotiations by Medicare would violate the First and Fifth Amendments of the U.S. Constitution. Merck, Bristol Myers Squibb and Astellas have made the same argument in separate lawsuits. Last week in federal court in Washington, D.C., Merck applied more pressure, filing for a decision in its case without a trial. The U.S. Chamber of Commerce and industry association PhRMA have also filed suits with similar claims. “The government is forcing (J&J) to provide its innovative, patented medicines on pricing terms that by law must be significantly below market prices,” J&J said in a release. “This would upend the current self-sustaining cycle of pharmaceutical innovation that provides patients with access ...
Recently, Zhejiang Pukang Biotechnology Co., Ltd. has completed the Phase IV clinical trial titled “Single-Arm, Multi-Center Evaluation of the Safety and Immunogenicity of Freeze-Dried Live Attenuated Hepatitis A Vaccine in Chinese Children Aged 18-24 Months” and received the final report. This Phase IV clinical study, involving a large sample size of 10,000 cases across multiple centers, aimed to observe the safety and immunogenicity of the freeze-dried live attenuated Hepatitis A vaccine in the real world. The study results show that after a single dose of the vaccine, the AEFI incidence rate in the 18-24 month-old children was 0.34%, with no serious AEFI reported, and an antibody seroconversion rate of 98.91%. This confirms the vaccine’s good safety and immunogenicity profile, providing richer data support for its widespread application. The freeze-dried live attenuated Hepatitis A vaccine (H2 strain), developed and produced by Zhejiang Pukang Biotechnology Co., Ltd., simulates ...
Chakrabartty’s lab created a battery-powered portable instrumentation that connects with a stretchy patch that places electrodes around the wearer’s abdomen. The electrodes detect both maternal heartbeat and EMG signals, which correspond to uterine contractions. Chuan Wang created flexible electrodes that Chakrabartty’s group used to build the device. Credit: Washington University in St. Louis Keeping track of pregnancy requires a dizzying array of gargantuan and expensive machines. An MRI machine is the size of a room and can cost up to $1 million. But the care such equipment provides is a critical part of prenatal care, especially for dealing with complications like preterm birth. To get this care, pregnant people frequently need to visit a hospital, a significant burden for underserved and disadvantaged communities. In a paper published May 19 in early access online in IEEE Transactions on Biomedical Circuits and Systems, a collaboration of researchers at Washington University St. ...
Following a three-month delay to provide more time for review, the FDA is scheduled on July 24 to decide on Daiichi Sankyo’s proposal to administer quizartinib in combination with standard chemotherapy to treat patients with acute myeloid leukemia (AML). The FDA first accepted Daiichi Sankyo’s NDA in October 2022 and granted it Priority Review, which is meant to accelerate the regulator’s decision. However, in April 2023, the FDA pushed the action date back by three months to accommodate updates to the proposed Risk Evaluation and Mitigation Strategies for quizartinib. Daiichi Sankyo is backing its NDA with data from the Phase III QuANTUM-First trial, which demonstrated that quizartinib can cut the risk of death by 22.4% in AML patients compared to chemotherapy alone. This advantage persisted until 40 months of follow-up, at which point the quizartinib arm had more than double the median overall survival of placebo comparators. ...
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