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 ...
Normal aging is associated with progressive cognitive decline. But can we train our brain to delay this process? A team from the University of Geneva (UNIGE), HES-SO Geneva and EPFL has discovered that practicing and listening to music can alter cognitive decline in healthy seniors by stimulating the production of grey matter. To achieve these results, the researchers followed over 100 retired people who had never practiced music before. They were enrolled in piano and music awareness training for six months. These results open new prospects for the support of healthy ageing. They are reported in NeuroImage: Reports. Throughout our lives, our brain remodels itself. Brain morphology and connections change according to the environment and the experiences, for instance when we learn new skills or overcome the consequences of a stroke. However, as we age, this ”brain plasticity” decreases. The brain also loses grey matter, where our precious neurons ...
Reviewed by Emily Henderson, B.Sc.Apr 17 2023 Normal aging is associated with progressive cognitive decline. But can we train our brain to delay this process? A team from the University of Geneva (UNIGE), HES-SO Geneva and EPFL has discovered that practicing and listening to music can alter cognitive decline in healthy seniors by stimulating the production of grey matter. To achieve these results, the researchers followed over 100 retired people who had never practiced music before. They were enrolled in piano and music awareness training for six months. These results open new prospects for the support of healthy ageing. They are reported in NeuroImage: Reports. Throughout our lives, our brain remodels itself. Brain morphology and connections change according to the environment and the experiences, for instance when we learn new skills or overcome the consequences of a stroke. However, as we age, this ”brain plasticity” decreases. The brain also loses grey ...
The combination of an experimental mRNA vaccine with an immunotherapy reduced the likelihood of melanoma recurring or causing death by 44% when compared to immunotherapy alone, a new clinical trial shows. Led by researchers at NYU Langone Health and its Perlmutter Cancer Center, the randomized phase 2b trial involved men and women who had surgery to remove melanoma from lymph nodes or other organs and were at high risk of the disease returning in sites distant from the original cancer. Among 107 study subjects who were injected with both the experimental vaccine, called mRNA-4157/V940, and the immunotherapy pembrolizumab, the cancer returned in 24 subjects (22.4%) within two years of follow-up, compared with 20 out of 50 (40%) who received only pembrolizumab. “Our phase 2b study shows that a neoantigen mRNA vaccine, when used in combination with pembrolizumab, resulted in prolonged time without recurrence or death compared with pembrolizumab alone,” said study senior investigator ...
The copycat version of AbbVie’s blockbuster still has court clearance to launch on July 1, but only if regulators have approved it. For a second time, the Food and Drug Administration has rejected Alvotech’s Humira biosimilar, citing deficiencies spotted during a March inspection of its manufacturing facility in Iceland, the company said Thursday. The agency’s decision comes less than three months before Alvotech is free to launch the drug in the U.S. under a settlement with AbbVie, Humira’s manufacturer. Alvotech has a second FDA application pending that, if approved by June 28, would make it one of the first “interchangeable” Humira biosimilars, meaning pharmacists could directly substitute it for the branded product. An expected launch on July 1 could be delayed if the FDA doesn’t grant the main approval, which would clear the biosimilar for sale in the U.S. In a statement Thursday evening, Alvotech said it provided ...
Although smoking rates for adults in the US are at their lowest recorded levels, more must be done to stop children from using tobacco, according to a new set of policy statements from the American Academy of Pediatrics. The statements, published Monday, are the association’s first tobacco policy update since 2015. They’re based on newer science and better reflect how many children now use e-cigarettes as more kid-friendly products have flooded the market. AAP policy statements are created by expert pediatricians to help leaders craft more effective public health policy and to guide physicians on how to keep kids safe – in this case, from tobacco. High rates of tobacco use Researchers have been telling Americans for generations that tobacco products are bad for them, yet nearly 200 US children take up smoking every day, according to the US Centers for Disease Control and Prevention. Tobacco ...
More than 2.5 million cases of sexually transmitted infections were reported in 2021, jumping by 7% in one year, according to new data from the US Centers for Disease Control and Prevention. “The US STI epidemic shows no signs of slowing,” said Dr. Leandro Mena, director of the CDC’s Division of STD Prevention. Chlamydia accounted for more than half of the reported cases, with rates increasing about 4% in 2021. Cases of gonorrhea rose nearly 5%. Cases of syphilis surged 32% in one year, including an alarming rise in infections passed from pregnant mothers to babies developing in the womb. In 2021, congenital syphilis caused 220 stillbirths and infant deaths. “The most important thing to remember is that congenital syphilis is 100% preventable,” Mena said. “In many ways, it is the result of our failure to prevent syphilis among women of reproductive age and their partners.” ...
After decades under Johnson & Johnson, a massive plant that once cranked out over-the-counter mainstays like Pepcid and Imodium is poised to hit the market. The plant handover comes after last month’s news that Johnson & Johnson would cut 57 positions at the Lancaster County facility, as detailed in a local Worker Adjustment and Retraining Notification Act notice. High Properties acquired J&J’s Greenfield, Pennsylvania, consumer health facility for $14 million, local news outlet Lancaster Online first reported. Fierce Pharma has viewed a copy of the deed confirming the sale, which went through in late March. J&J and High Properties did not immediately respond to Fierce Pharma’s request for comment on the matter. Reference: https://deal.town/questex/041223-takeda-hit-with-another-pay-for-delay-lawsuit-after-layoff-warning-jandj-inks-14m-plant-sale-F34YGQUSL
April 13, 2023 By Sean Whooley Leave a Comment FacebookTwitterLinkedIn分享 Rice University Ph.D. student Tyler Graf holds a microscope slide. It holds an array of more than 300 tiny biodegradable particles. These can be used for time-released drug delivery. (Photo by Brandon Martin/Rice University) Bioengineers at Rice University developed a new technology for delivering drugs in a time-releasing manner. Kevin McHugh, corresponding author of a study about the technology, believes this could make missing doses of medicines and vaccines a thing of the past. McHugh and the Rice team saw their work published online in Advanced Materials. According to McHugh and graduate student Tyler Graf, encapsulating medicine in microparticles that dissolve and release drugs over time isn’t new. However, they believe their method — using 21st century methods to develop next-level encapsulation technology —offers more versatility in medication delivery. “This is a huge problem in the treatment of chronic disease,” McHugh said in a post ...
A technique that identifies the build-up of abnormal protein deposits linked to Parkinson’s disease could aid in early detection and play a key role in the disease’s clinical diagnosis and characterization, according to research published in The Lancet Neurology journal. Findings from the study confirm that the technique—known as α-synuclein seed amplification assay (αSyn-SAA)—can accurately detect people with the neurodegenerative disease and suggest it can identify at-risk individuals and those with early, non-motor symptoms prior to diagnosis. The presence of misfolded α-synuclein protein aggregates in the brain is the pathological hallmark of Parkinson’s disease. Co-lead author Professor Andrew Siderowf, of the University of Pennsylvania Perelman School of Medicine (U.S.) and Parkinson Progression Marker Initiative (PPMI) investigator, says, “Recognizing heterogeneity in underlying pathology among patients with Parkinson’s disease has been a major challenge. Identifying an effective biomarker for Parkinson’s disease pathology could have profound implications for the way we treat the condition, potentially ...
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