PharmaFocus Today – Page 368 – media

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
- 137
- 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
- 139
- 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
Abliva’s NV354 receives ODD from US FDA

Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease. Sweden-based Abliva has announced that its drug candidate NV354 has been received orphan drug designation (ODD) from the US FDA Office of Orphan Products Development to treat mitochondrial disease. Abliva is a clinical-stage company developing medicines to treat rare and severe primary mitochondrial diseases. NV354 is an orally available compound being developed to treat severe primary mitochondrial diseases including Leigh syndrome. Leigh syndrome is a rare disease mainly impacting the central nervous system. Abliva CEO Ellen Donnelly said: “The granting of ODD to NV354 by the U.S. FDA is a validation of the quality of the NV354 pre-clinical program and another important milestone for Abliva. The ODD will be beneficial to us as we work to progress ...
- Source: drugdu
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- April 19, 2023
FDA gives approval to cell therapy Omisirge for blood cancer patients

The US Food and Drug Administration has granted approval to Gamida Cell for Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy. This therapy helps to pace up the recovery of neutrophils (a subset of white blood cells) in the body and lower risk infection. Omisirge is intended for use in adults and pediatric patients aged 12 years and above with blood cancers planned for umbilical cord blood transplantation after a myeloablative conditioning regimen i.e. treatment such as radiation or chemotherapy). US FDA’s Center for Biologics Evaluation and Research director Peter Marks said: “Today’s approval is an important advance in cell therapy treatment in patients with blood cancers. “Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation. This approval reflects the FDA’s continued commitment to supporting development of innovative ...
- Source: drugdu
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- April 19, 2023

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