Anti-inflammatory drugs may reduce deaths due to Covid-19, but they do not help speed up the recovery for those in hospital, according to a recent study. Results from s study, published in The Journal of the American Medical Association, demonstrated that giving abatacept, cenicriviroc, or Johnson and Johnson’s Remicade (infliximab) in addition to standard of care did not decrease time to recovery for patients hospitalised with Covid-19 pneumonia. The standard of care included in this study involved Gilead Sciences’ Veklury (remdesivir) and the corticosteroid dexamethasone. Patients who took either one of the three drugs recovered after a similar number of days compared to those who were on placebo. The investigators also measured mortality across the sub-studies by day 28 – which did show slight differences, though not statistically significant. Abatacept and Remicade led to a narrow decrease in patient deaths – a 4.1% and 4.4% difference respectively, whilst ...
Pictured: Sign of U.S. Department of Health & Human Services at its headquarters in Washington/iStock, JHVEPhoto The Centers for Medicare and Medicaid Services will now provide broader coverage for Eisai and Biogen’s Alzheimer’s disease therapy Leqembi (lecanemab), the federal agency announced Thursday. The Medicare coverage expansion comes after Leqembi won the FDA’s traditional approval, making it the first anti-amyloid and disease-altering treatment to do so. Eisai and Biogen were granted accelerated approval for Leqembi in January and soon commenced their bid for full approval with data from the Phase III Clarity-AD study. According to CMS, only patients enrolled in Medicare and with physicians participating in a qualified registry will be eligible for reimbursement—provided their doctors collect their data as real-world evidence for Leqembi and submit it to a registry. Coverage is restricted to those who are diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with evidence of beta-amyloid deposits in the brain. “With FDA’s decision, CMS will ...
PacBio, a leading developer of high-quality, highly accurate sequencing solutions, today announced that Bioscientia is using its Revio long-read sequencing system to expand its genomics research projects and sequence several thousand human genomes per year. Part of Sonic Healthcare Group, Bioscientia is a leading global provider of clinical laboratory testing services for diagnostics based in Germany. The increased accuracy, read length and methylation insights offered by the Revio system will enable Bioscientia to explore certain monogenic disorders, such as deafness, blindness, and developmental delay, and study the underlying causes of rare diseases. “Bioscientia is a world-leading provider of testing services, and we are thrilled that they have chosen Revio to explore the potential clinical use of long-read sequencing,” said Christian Henry, President and Chief Executive Officer of PacBio. “Revio will help enable Bioscientia to deliver more insights to families with fewer tests, lower overall costs, and less time spent ...
An estimated 50 million individuals in the United States struggle with the challenges of cocaine or alcohol use disorders, according to the National Institutes of Health (NIH). Beyond the well-documented health risks, addiction to these substances detrimentally affects our cognitive flexibility, which is the ability to adapt and switch between different tasks or strategies. Although previous research has hinted at this connection, the underlying reasons for this cognitive impairment remain elusive. Cognitive flexibility is a crucial element in various domains of our life, including academic achievement, employment success and transitioning into adulthood. As we age, this flexibility plays an important role in mitigating cognitive decline. A deficiency in cognitive flexibility, however, is linked to academic deficits and a lower quality of life. A study led by Dr. Jun Wang, associate professor in the Department of Neuroscience and Experimental Therapeutics at the Texas A&M University School of Medicine, provides new insight into the ...
The US Food and Drug Administration (FDA) has granted traditional approval for Eisai and Biogen’s Leqembi (lecanemab-irmb) 100mg/mL injection to treat Alzheimer’s disease (AD) in adults. With the approval of the supplemental biologics licence application (sBLA), Leqembi becomes the first therapy to slow disease progression rate and cognitive and functional decline in AD patients. This development is based on findings from the Phase III portion of Eisai’s Clarity AD clinical trial. Trial data showed that the product met the Leqembi primary endpoint and all crucial secondary endpoints, and also demonstrated clinical benefit. In January 2023, the regulatory agency granted accelerated approval for Leqembi. Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and amyloid beta’s (Aβ) insoluble forms. Eisai CEO Haruo Naito stated: “The FDA approved Leqembi under the traditional approval pathway, making Leqembi the first and only approved anti-amyloid Alzheimer’s disease treatment shown ...
By Heather McKenzie Pictured: Physician with notepad/iStock, Everyday better to do everything you love The European Medicines Agency recently flagged a safety signal regarding the potential for glucagon-like peptide-1 receptor agonists to cause thyroid cancer. The documentation—the first step taken by the regulator toward investigation of potential adverse events in approved products—comes as demand for the popular diabetes and weight loss drugs reaches a fever pitch. The safety signal reported by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in April covers a range of glucagon-like peptide-1 receptor (GLP-1) agonists, including semaglutide, the key ingredient in Novo Nordisk’s Wegovy, Ozempic and Rybelsus. Supplemental information was also requested from Eli Lilly, Sanofi and AstraZeneca, all of which manufacture drugs in this class. GLP-1 is a hormone that stimulates insulin secretion after eating, enabling a feeling of fullness and regulating blood sugar. GLP-1 agonists mimic the effects of this hormone, making them an ...
If the face mask fits, it’s much safer—say Flinders University medical experts after developing a low-cost way to customize N95 filtering facepiece respirators (FFRs) for health workers on the front line of the pandemic and respiratory viruses such as influenza. Researchers say the decrease in “leakage” and greater comfort for the wearer whose face has been personally fitted could also have applications to improving respirator and mask safety in a wide range of industrial settings in health care and beyond. The article, “Personalized 3D-printed frames to reduce leak from N95 filtering facepiece respirators: a prospective crossover trial in health care workers” has been published in the Journal of Occupational and Environmental Hygiene. “Individually and anatomically personalized 3D-printed face frames represent a rapidly scalable technology to significantly improve health care worker protection and comfort, and fit-testing pass rates,” says Flinders University cardiology research fellow Darius Chapman. Working with public hospital workers ...
While Dupixent often steals the show, Sanofi isn’t sleeping on its vaccine franchise. Boasting prophylactic prospects in respiratory syncytial virus (RSV), pneumococcal disease and flu—including a clutch of promising mRNA candidates—the French pharma feels confident its shots can deliver billions of dollars by the end of the decade. By 2030, Sanofi figures its immunizations could generate more than €10 billion in annual sales, the company said during a vaccines R&D event Thursday. Much of that momentum hinges on Sanofi’s pipeline, where the company is targeting an “accelerated pace of innovation” in a bid to launch at least five innovative phase 3 vaccine programs by 2025. “When developing new vaccines, our scientists can now choose from nine distinct platforms—probably the largest number in the industry,” Thomas Triomphe, Sanofi’s executive vice president of vaccines, said of the company’s future immunization prospects. And despite big things on the horizon—principally in the form of ...
When excess surgical site infections (SSIs) were detected among neurosurgery patients at University of Pittsburgh Medical Center (UPMC) Mercy in 2019, infection preventionist Katie Palladino, MPH, CPH, CIC, partnered with a hospital neurosurgeon on a multidisciplinary quality and process improvement initiative that led to a steep drop in infection rates over a two-year period. Their successful initiative is being presented at the Association for Professionals in Infection Control and Epidemiology’s (APIC’s) Annual Conference in Orlando Florida, June 26-28. Palladino and the surgeon began the initiative by reviewing the path of a surgical patient—from the first pre-op meeting to the surgery, to the patient’s discharge from the hospital—observing practices and looking for opportunities where infections could arise. They also reviewed pre-surgical instructions for patients and found ways to improve information about chlorhexidine gluconate (CHG) bathing, nasal decolonization, and other important infection prevention practices. The next step was a literature review of ...
By Elaine Chen STAT – Reporting from the frontiers of health and medicine Liver illustration HYACINTH EMPINADO/STAT SAN DIEGO — The American Diabetes Association said Sunday that all adults with type 2 diabetes or prediabetes should be screened for nonalcoholic fatty liver disease, an increasingly prevalent condition that can lead to serious liver damage. There are no approved medications for the disease, but among available diabetes drugs, the ADA singled out GLP-1 treatments as an option doctors could consider, according to recommendations published during the annual ADA conference. GLP-1 treatments, such as Ozempic and Mounjaro, are a class of drugs that have grown widely popular for their efficacy not only in lowering blood sugar, but also cutting weight. Drugmakers have started to study them in liver disease, and while some trials have shown they may offer some benefits, they haven’t yet been shown to improve harmful liver scarring. The ADA ...
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