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J&J study data show dramatic benefit to multiple myeloma cell therapy

A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs. The cancer cell therapy Carvykti dramatically outperformed standard drugs in a late-stage clinical trial testing its use in earlier treatment of the blood cancer multiple myeloma, according to data from a study abstract that was briefly posted online Tuesday. The abstract showed Carvykti, which is made by Johnson & Johnson and Legend Biotech, reduced the risk of disease progression or death by 74% compared to standard of care — a degree of benefit that analysts who viewed it described as “stellar” and “highly encouraging.” J&J and Legend had previously said in late January that the study met its main goal, but did not disclose any specific data at the time. The abstract, which is no longer available online, was for presentation ...
- Source: drugdu
- 114
- April 20, 2023
Ardelyx resubmits NDA for Xphozah to US FDA

Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA). A first-in-class, phosphate absorption inhibitor, Xphozah will be used to control serum phosphate in adults with chronic kidney disease (CKD) on dialysis and who had an insufficient response or intolerance to a phosphate binder therapy. It has a new action mechanism and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3). This reduces the absorption of phosphate via the paracellular pathway, which is the main pathway of phosphate absorption. Diarrhea was the most common side effect using Xphozah in clinical trials. The NDA submission was supported by a comprehensive development programme, which included over 1,200 patients in three Phase III clinical trials, PHREEDOM, BLOCK and AMPLIFY, and two additional open-label Phase IV clinical trials, OPTIMIZE and NORMALIZE. The Phase III trials were ...
- Source: drugdu
- 137
- April 20, 2023
Is there a link between psychiatric and reproductive system disorders in women?

In a recent study published in the journal JAMA Network Open, researchers performed a meta-analysis to assess the co-occurrence of reproductive and psychiatric disorders among women. Disorders associated with the female mental well-being and reproductive tract commonly co-exist; however, the precise cause of the co-occurrence is not clear. Probable causes include non-intrinsic or external-type factors that interfere with the reproductive system, including psychotropic-type medications, psychosocial causes like reproductive disorders impacting relationships and life quality, and stress affecting reproductive functions and the menstrual cycle. Moreover, the overlap could originate from genetic causes. About the study In the present meta-analysis, researchers determined the association between female reproductive and psychiatric functions. The PubMed database was searched for observational-type and peer-reviewed studies (population-level cross-sectional and case-control studies), including reproductive-age females aged between 13.0 and 55.0 years, published from January 1980 to December 2019, evaluating the prevalence of mental health disorders among ...
- Source: drugdu
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- April 20, 2023
CDC signs off on additional Covid-19 booster doses for certain people

The US Centers for Disease Control and Prevention updated its recommendations on the Covid-19 vaccines on Wednesday to allow another dose of the bivalent booster for people who are 65 and older or who have weakened immune systems and who “want the option of added protection” against the coronavirus. The move aligns with Tuesday’s US Food and Drug Administration actions to allow these groups to get additional booster doses ahead of the fall vaccination campaign. On Wednesday, members of CDC’s Advisory Committee for Immunization Practices met to discuss the changes and expressed their support for them, although the committee did not vote. Monovalent mRNA vaccines, which protect only against the original strain of the coronavirus, will no longer be recommended in the United States, the CDC says. The updated bivalent shots from Moderna and Pfizer/BioNTech protect against the original strain as well as the BA.4 and BA.5 subvariants ...
- Source: drugdu
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- April 20, 2023
Are Electric Vehicles Safe for Pacemaker Patients?

A new study investigates the risk of electromagnetic interference with pacemakers and defibrillators when using high power electric vehicle chargers. Amanda Pedersen | Apr 19, 2023 With the increasing popularity of electric vehicles, you might be wondering if it’s safe to drive or charge one of these bad boys if you have a pacemaker or defibrillator. According to a new study, presented this week at the European Heart Rhythm Association (EHRA) in Barcelona, Spain, the answer is yes – so long as you don’t place the charging cable directly over your cardiac device, or stay near the charging cable for extended lengths of time. The study was also published in EP Europace, a journal of the European Society of Cardiology, which hosts the EHRA scientific congress. “The new high power charging stations for electric cars have the potential to create strong electromagnetic fields and cause electromagnetic interference in pacemakers and defibrillators, leading them to malfunction,” said study author ...
- Source: drugdu
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- April 20, 2023
Study Suggests Increased Number of PMA Supplements Increase Recall Risk

Investigators also highlighted long-standing concerns that modified devices may bear little resemblance to the device originally FDA-approved. Katie Hobbins | Apr 19, 2023 Recently, a study published in JAMA Network Open reported that high-risk medical devices whose manufacturers file supplements to the FDA so modifications can be made to PMA-approved products are 30% more likely to be the subject of any recall and high-risk Class I recall. Makers of Class III PMA devices are offered five different types of supplements to allow for product improvements. Only one of the supplements — namely, panel track supplements — actually require clinical evidence for implementation and, as such, are the least-used type of the five, (approximately 1%). In contrast, the most used supplement type is a 30-day notice. A 30-day notice is used when a company makes changes to a manufacturing procedure or the way it makes a device. In the study, investigators analyzed devices approved through ...
- Source: drugdu
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- April 20, 2023
How the brain tells the liver to start recycling after fasting

Fasting triggers autophagy in our body. The body switches on the waste disposal system in the cells and gains new energy. Researchers at the Max Planck Institute for Metabolism Research in Cologne have now shown in mice that the brain plays a decisive role in this process. Even after a short period of fasting, the brain triggers the release of the hormone corticosterone and thus initiates autophagy in the liver. Until now, it was assumed that mainly the liver cells themselves were responsible for this. In the long term, these findings could help us understand why fasting is so healthy for the body. Autophagy is essential for survival. Defective or damaged molecules are shredded and degraded by the cell’s own waste disposal system and new energy is generated from this. This kind of detoxification of the body keeps the body fit and very likely young. “Until now, it was assumed that our body cells mainly ...
- Source: drugdu
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- April 19, 2023
Researchers discover critical protein for common bone growth disorder

A team led by UT Southwestern Medical Center researchers has discovered a protein that appears to be pivotal for traumatic heterotopic ossification (HO), a condition in which bone forms in muscles, tendons, and other soft tissues after traumatic injury or surgery. The findings, published in Science Advances, could yield new ways to prevent this common complication, the researchers say. “Right now, we have no ways to prevent HO from occurring, which can cause significant impairments in quality of life. For example, it can alter patients’ range of motion, producing chronic pain, and affect the ability of amputees to fit into prostheses,” said Benjamin Levi, M.D., Associate Professor of Surgery and Plastic Surgery, and Chief of the Division of Burn, Trauma, Acute, and Critical Care Surgery at UT Southwestern. “Hopefully, these new findings will lead to treatments that can stop this process from unfolding so patients never develop it.” HO occurs when cells ...
- Source: drugdu
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- April 19, 2023
Discovery suggests a new way to treat spinal muscular atrophy

Journal reference: Kim, J.-K., et al. (2023). A spinal muscular atrophy modifier implicates the SMN protein in SNARE complex assembly at neuromuscular synapses. Neuron. doi.org/10.1016/j.neuron.2023.02.004 Columbia researchers have discovered how a genetic defect leads to spinal muscular atrophy (SMA), a critical piece of information about the disease that neurologists have been seeking for decades. The discovery suggests a new way to treat SMA-;a devastating childhood motor neuron disease that affects 1 in 6,000 children. In the most severe cases, and when left untreated, children born with SMA die within the first two years of life. The researchers also used their finding to develop an experimental therapy that improved survival in mice with severe SMA by 30-fold, one of the greatest increases seen with any treatment in mouse models of SMA. Why the finding matters Almost all cases of SMA are caused by a mutation in a ...
- Source: drugdu
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- April 19, 2023
Study reveals the risk factors associated with developing long Covid

Journal reference: Tsampasian, V., et al. (2023) Risk Factors Associated With Post−COVID-19 Condition. JAMA Internal Medicine. doi.org/10.1001/jamainternmed.2023.0750. Being vaccinated against Covid halves people’s risk of developing long Covid, according to new research from the University of East Anglia. Long Covid still affects some two million people in the UK, and new research published today reveals the risk factors associated with developing the condition. Overweight people, women, smokers and those over the age of 40 are also more likely to suffer from long Covid according to the study – which includes more than 860,000 patients and is thought to be the largest of its kind. The study also finds that co-morbidities such as asthma, COPD, Type 2 Diabetes, coronary heart disease, immunosuppression, anxiety and depression are also associated with increased risk of long Covid. And patients who are hospitalized during their acute Covid infection are also ...
- Source: drugdu
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- April 19, 2023

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