Spikevax, the COVID-19 vaccine from Moderna, has today been authorized for use in children aged 6 months to 5 years. The vaccine has been authorized in this new age group after it has been found to meet our standards of safety, quality and effectiveness, with no new safety concerns identified. This followed advice from the Commission on Human Medicines, which carefully reviewed the evidence. This is the second COVID-19 vaccine to be authorized in this age group; the Pfizer/BioNTech vaccine (Comirnaty), was authorized in Great Britain for infants and children aged 6 months to 4 years on 6 December 2022. For this age group, the vaccine is given as a primary series of two 25-microgram injections in the upper arm or in the thigh, approximately one month apart. In reaching their decision, the MHRA’s experts carefully reviewed data from an ongoing clinical trial involving 6,388 children aged 6 months to ...
The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards. Equipped with advanced isolator technology, the Pleasant Prairie facility adheres to the highest current good manufacturing practice (CGMP) standards. It is designed to manufacture a broad range of injectable medications and will provide hospitals and clinicians access to affordable, safe, and critical-need medicines. Nexus Pharmaceuticals President and CEO Usman Ahmed said: “We are thrilled to receive the EIR for our Pleasant Prairie facility. “This is a major milestone for our company and reflects our commitments to reshoring sterile pharmaceutical manufacturing to the US. “We are proud of our team’s hard work and focus on achieving a ...
Quitting smoking early was associated with higher survival rates following a lung cancer diagnosis, according to a new study led by researchers at Harvard T.H. Chan School of Public Health. Compared to those who never smoked and were being treated for non-small cell lung cancer (NSCLC), current smokers had 68% higher mortality and former smokers had 26% higher mortality. Our participants’ smoking histories varied, with some having stopped smoking a few years before their diagnosis and others having stopped several decades before. This wide range gave us confidence in our results—that the benefit of pre-diagnosis smoking cessation persists even after lung cancer is diagnosed.” David Christiani, Senior Author, Elkan Blout Professor of Environmental Genetics The study was published online in JAMA Network Open on May 5, 2023. While most similar research has compared mortality among current smokers and never smokers, the majority of the study’s participants were former smokers, ...
There are currently 8 million patients with Parkinson’s disease in the world. In 2021, Professor Per Saris’s group published results demonstrating that bacteria of the Desulfovibrio bacterial genus correlate with Parkinson’s disease, and that their higher number also correlates with the severity of the symptoms of the disease. Replicating the same study, Chinese researchers came to the same conclusion. “Our findings are significant, as the cause of Parkinson’s disease has gone unknown despite attempts to identify it throughout the last two centuries. The findings indicate that specific strains of Desulfovibrio bacteria are likely to cause Parkinson’s disease. The disease is primarily caused by environmental factors, that is, environmental exposure to the Desulfovibrio bacterial strains that cause Parkinson’s disease. Only a small share, or roughly 10%, of Parkinson’s disease is caused by individual genes,” says Professor Per Saris from the University of Helsinki. The goal of Professor Saris’s research group ...
In order to carry out a seamless joint replacement, surgeons must create a customized preoperative plan for each patient. However, surgeons having to perform multiple operations per day are often too busy to dedicate adequate time to this step. Formus Labs, a New Zealand-based medical technology startup, is on a mission to make the preoperative planning process much quicker. On Wednesday, the company received 510(k) clearance from the FDA for Formus Hip, its fully automated 3D software for hip replacement preoperative planning. The company announced its plans to expand into the U.S. last year. Wednesday’s FDA clearance represents a major milestone, as Formus can now begin to sell its product to surgeons and healthcare providers across the country. Founded in 2017, Formus seeks to solve the problem of patient dissatisfaction and unsustainable costs in joint replacement surgery, said CEO Ju Zhang in a recent interview. “Our approach to solving this ...
The guidance focuses on respiratory pathogens, including influenza and respiratory syncytial virus. The World Health Organization (WHO) has launched a new initiative to help countries better prepare for future pandemics. The new ‘Preparedness and Resilience for Emerging Threats Initiative’ incorporates the latest tools and approaches for shared learning and collective action established during the COVID-19 pandemic and other recent public health emergencies, according to WHO. The initiative’s first module focuses specifically on responding to the threat or arrival of respiratory pathogens, including influenza, COVID-19 and respiratory syncytial virus. This will enable countries to critically review, test and update their respiratory pandemic planning efforts to ensure they have the functional capacities and capabilities in place. A process is currently underway to identify the next group of pathogens, such as arboviruses, to be addressed under this initiative. Dr Tedros Adhanom Ghebreyesus, WHO director-general, said: “Preparedness, prevention, and ...
Recurrent Clostridioides difficile infection can be treated with fecal microbiota transplants. FDA approval of Seres Therapeutics’ Vowst makes it the first oral microbiome therapy. A capsule filled with bacteria is now FDA approved for treating a serious and potentially deadly type of gut infection, making the Seres Therapeutics drug the first oral microbiome therapy to receive the regulatory go-ahead for patients. The infection is caused by Clostridioides difficile (C. difficile or C. diff), a bacterium that’s part of the diverse microbial community in the intestines. When the gut microbiome is disrupted, C. diff can proliferate, releasing toxins that cause frequent diarrhea, abdominal pain, and fever. In severe cases, the infection leads to organ failure and death. Antibiotics can treat C. diff infection, but these bacteria can develop resistance, leading to a recurrence of the infection. When that happens, patients have limited treatment options. According to Centers for Disease Control and Prevention data cited by Seres, about 156,000 cases of ...
Researchers have found the “Eat, Sleep, Console” (ESC) care approach to be more effective than using the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to assess and manage opioid-exposed newborns, according to a national, randomized controlled clinical trial. Newborns cared for with ESC were medically ready for discharge approximately 6.7 days earlier and 63% less likely to receive medication as part of their treatment, compared to newborns cared for with FNAST. ESC prioritizes non-pharmacologic approaches to care, such as a low-stimulation environment, swaddling, skin-to-skin contact and breastfeeding. ESC also encourages parental involvement in the care and assessment of their infants. These findings are based on the hospital outcomes of a large and geographically diverse group of opioid-exposed infants. A two-year follow-up study of a subset of infants is ongoing. The current findings are published in the New England Journal of Medicine. “Medical care for newborns who were ...
Through data-analysis, researchers found that people taking long siestas had higher body mass indexes and were more likely to have metabolic syndrome than those who did not take siestas. It is a common custom in some countries for individuals to take a siesta or midday nap. Sleeping during the middle of the day has the potential to affect sleep quality, cognitive function, and metabolic processes. However, the relationship between siestas and metabolic health is not well understood. A new study led by investigators from Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, assessed more than 3,000 adults from a Mediterranean population, examining the relationship of siestas and siesta duration with obesity and metabolic syndrome. The researchers found that those who took siestas of 30 minutes or longer (long siestas) were more likely to have a higher body mass index, higher blood pressure, and ...
By Michael Greenwood, M.Sc.Reviewed by Danielle Ellis, B.Sc. Doggybone DNA ™ (dbDNA) is a technology developed by biotech company Touchlight, which is a form of linear plasmid with applications in genetic engineering and therapeutics. Plasmids are small circular double-stranded DNA molecules naturally generated by bacterial cells, some eukaryotes, and archaea and separate from chromosomal DNA. Plasmids can self-replicate by using host enzymes, and each carries at least one gene, most of which are beneficial to the host. The gene(s) carried by the plasmid may then be incorporated into the genome for expression. For example, a plasmid may encode a gene that produces a protein with antiphage functionality, allowing viral resistance to be incorporated into the bacterial chromosome. Plasmids are transferred between bacterial cells via pili; thus, beneficial genes carried by plasmids can be disseminated and incorporated into the chromosomal DNA of neighboring cells. Owing to the natural function of plasmids, they can be ...
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