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US FDA Approves Novartis’ New Kidney Disease Drug, Fabhalta
US FDA Approves Novartis’ Fabhalta for IgA Nephropathy, Showing 44% Reduction in Urine Protein Levels.
United States: Novartis has received special approval from the FDA for a new medicine called Fabhalta. This drug is used to help people with a rare kidney disease called IgA nephropathy (IgAN). Fabhalta helps reduce the amount of protein in the urine, which is a basically a sign of kidney trouble.
Study Results and Approval
As reported by Reuters, the approval was based on a study where Fabhalta showed it could lower protein levels by 44% after nine months compared to no treatment. This study involved 518 adults with IgAN and checked how well Fabhalta works and how safe it is over two years.
Secondary endpoints include urine protein-to-creatinine ratio reduction, composite kidney failure events and changes in fatigue levels.
Continued approval depends on further evidence of clinical benefit, with final study results expected in 2025.
Ongoing Development
The APPLAUSE-IgAN study’s interim analysis is focused on proteinuria reduction, a key marker of kidney damage. Fabhalta demonstrated a significant 38% reduction in proteinuria compared to placebo.
Which also includes the patients on stable doses of renin-angiotensin system inhibitors, with or without sodium-glucose cotransporter-2, and Fabhalta’s safety profile was consistent with previous findings.
Novartis is also developing two additional IgAN therapies, atrasentan and zigakibart, in late-stage trials.
Company Statement
Novartis US president Victor Bultó stated: “Today’s approval of Fabhalta as a first-in-class medicine for IgA nephropathy is an important milestone in our journey to evolve rare renal disease care by bringing new treatments to people in urgent need of options.
“We are deeply committed to those living with rare renal diseases and look forward to continued partnership with this community as we further advance our broad portfolio.”
Atrasentan has received FDA filing acceptance, and zigakibart is currently in Phase III development.
“US FDA approves Novartis’ Fabhalta in IgAN treatment” was originally created and published by Pharmaceutical Technology, a Global Data owned brand.
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Naloxone Could Help Revive People After Opioid-Induced Heart Failure
The study highlights that naloxone significantly improves survival rates in cardiac arrests due to opioid overdoses and beyond.
United States: A new study shows that naloxone, a special medicine, can help save people who have had a heart stop because of an opioid overdose. Naloxone works quickly by stopping opioids from affecting the brain, which helps someone start breathing again if they’ve stopped due to the overdose. Opioids can also cause the heart to suddenly stop beating during an overdose, but naloxone can help fix this problem.
Increasing Drug-Related Cardiac Arrests
As reported by HealthDay, “The incidence of drug-related cardiac arrests has skyrocketed in the past two decades, and there is an urgent need for evidence to guide possible naloxone use in this circumstance,” said researcher Davis Dillon who is purely an assistant professor or we can say an educator of emergency medicine at the University of California, Davis.
Most of the cardiac arrests due to the heart attacks or electrical problems in the heart of but the opioid OD-related cardiac arrests are a major cause of death among the adults who ages between 64 said the researchers.
So hereby almost or can say more than 15 percent of the opioid OD cases are treated by paramedics involve in the cardiac arrest the American Heart Association says.
Study Findings
To accomplish this research, the investigators assessed data on 7,960 patients with opioid-associated cardiac arrest in three Northern California counties between 2015 and 2023.
In the OD cardiac arrest patients, the investigators also noted that out of 9 patients who received naloxone, 1 had a shockable cardiac rhythm and their heart began beating again with restored blood circulation.
Data of this study showed that one of the patients treated with naloxone was alive and was discharged from the hospital after every 26 patients.
The new study is here, JAMA Network Open, and it was released on August 20.
Implications of the Research
“To our surprise, our research revealed that use of naloxone was actually linked to a better survival rate in cardiac arrest incidents resulting from overdose or those unrelated to drugs,” the author of the university news release quoted Dillon. “This is important because it contributes our knowledge about efficacy of naloxone with regards to drug related, OHCA.
News
AI-Driven Implant Provides Adaptive Relief for Parkinson’s Patients
United States – A recently published clinical study has revealed an utterly inspiring new feature – an AI-powered device that can be implanted in the brain and help treat Parkinson’s disease. These are more effective for the patients, according to the researchers, because this new implant logs the patient’s symptoms and interacts with the patient in treatment.
How the AI-Powered Implant works
Parkinsonian disease where motor control and mobility is variable during waking hours, and at night. This new implant which is partially based on artificial intelligence continuously monitors these changes and relays the information to doctors. Where it identifies a form of activity that is unwanted it then triggers mild electric shocks to the specific area –DBS — which helps in eradicating the impacts, as reported by HealthDay.
This closed-loop system ensures that the implant adjusts the level of stimulation required to address the patient’s symptoms as he or she goes through activities in his or her daily life.
Promising Results from Phase 1 Study
In a phase 1 trial involving four patients, the implant was shown to reduce the most problematic symptoms of Parkinson’s disease by 50%. The study, published in Nature Medicine on August 16th, highlights the potential of this technology to significantly improve the quality of life for Parkinson’s patients.
“This is the future of deep brain stimulation for Parkinson’s disease,” said Dr. Philip Starr, senior researcher and co-director of the UCSF Movement Disorders and Neuromodulation Clinic. “There’s been a great deal of interest in improving DBS therapy by making it adaptive and self-regulating, but it’s only been recently that the right tools and methods have been available to allow people to use this long-term in their homes.”
Parkinson’s disease is a progressive neurological disorder which occurs due to the loss of dopamine producing neurons and is estimated to affect around 10 million people in the globe. When the motor symptoms do set in, the patients have difficulty with movement, developing tremors, rigidity, and balance problems. Although effective, traditional DBS therapy is monopolar, meaning that the electrical current is constant rather than dynamic, where DBS adaptation is necessary for corresponding to the condition of the patient and thereby affording reliable symptom management.
The new adaptive DBS implant, however, uses signals from the motor cortex to tailor the level of stimulation in real time. This personalized approach has shown significant promise in reducing the need for medication and improving symptom management.
A New Era of Neuro-Stimulation Therapies
Dr. Simon Little, an associate professor of neurology at UCSF, emphasized the significance of this breakthrough: “With adaptive DBS the big shift that we’ve made here is we are now able to tell at any given time how severe the symptoms of the patient are and properly match it with the amount of stimulation the patient needs.
Apart from enhancing the motoric feature of the disease, the adaptive DBS implant has also been noted to reduce sleep disorders in Parkinson’s disease patients according to a Nature Communication publication done this year, as reported by HealthDay.
Scientists are now trying out similar DBS treatments for other conditions of the brain; depression and obsessive-compulsive disorder. “We are aware that it has a great effect on patients, indicating that it can be used not only for Parkinson’s crown but possibly also for psychiatric disorders,” Starr stressed. “We are now simply in the starting line when it comes to neuro-stimulation therapies. ”
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Tech Trouble: How Parents’ Smartphone Addiction Impacts Their Children
Rising smartphone use among parents is linked to increased mental health issues in children, highlighting the need for more mindful device usage.
United States: Smartphone use is ultimately increasing across the globe which is becoming a central part of daily life for many. This rise in usage is basically raising serious concerns about its impact on both individuals and society. As more people spend hours each day on their devices, experts worry about the potential effects on mental health, personal relationships, and overall well-being.
Impact on Family Dynamics
At dinner time, a child might talk about their day at school or share a fight with a friend, but if parents are too busy looking at their smartphones to listen, it could be hurting the child’s feelings. A new study shows that this happens a lot every day in America and might be bad for kids’ mental health.
Study Findings on Child Development
As reported by HealthDay, Kids at the ages of 9 years to 11 years who said that their parents spent away too much on their smartphones are more likely to get anxiety and attention issues and hyperactivity later as compared to the youngsters of the parents who weren’t phone-obsessed, Canadian researchers reported that.
“When children’s emotional and physical needs are consistently ignored or inappropriately responded to, they are at risk of developing mental health difficulties,” explained a team led by Sheri Madigan, an associate professor of psychology at the University of Calgary in Alberta.
Technoference’s Long-Term Effects
According to the background data from the study one recent study found out that parents of infants now spend an average of almost more than five years on their smartphones daily, including looking at the smartphone 27 percent daily which includes looking at a smartphone 27 percent of the time they are engaging with their baby.
Here another study found 68 percent of the parents admitting they are often distracted by their smartphones as they interact with their kids for sure.
Research has shown that this kind of “technoference” while parenting means less attention paid to children, less parent-child conversation and play and even a higher risk for child injuries.
During adolescence, technoference is linked to “higher levels of parent-child conflict and lower levels of parental emotional support and warmth,” Madigan’s team noted.
Research Insights
Investigating the issue the further the Calgary group looked at the data form almost more than a thousand Canadian children ages from 9 to 11 and provided at the multiple points between 2020 and early 2022.
The children were also assessed for the various and different types of mental health issues such as anxiety and depression and hyperactivity and the inattention that developed over time.
According to Madigan’s team, “higher levels of [child] anxiety symptoms that were associated with higher levels of perceived parental technoference later in development.”
Too much parental time spent on the smartphone can lead forward to the higher levels of the inattention and hyperactivity symptoms later in the development.