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Positive CHMP opinion for UCB’s bimekizumab

by John Pinching Therapy concerns the treatment of adults with axial spondyloarthritis and psoriatic arthritis UCB has revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted marketing authorisation for bimekizumab in the EU. It concerns the treatment of adults with active axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA). AxSpA is an indication that covers both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS) – also known as radiographic axSpA (r-axSpA). In active PsA, the CHMP recommended approval of bimekizumab alone or in addition to methotrexate, for the treatment of adults who have had an inadequate response to one or more disease-modifying antirheumatic drugs. Furthermore, in active axSpA, the CHMP recommended approval of bimekizumab for treating adults with active nr-axSpA with objective signs of inflammation. Throughout all four relevant studies – BE OPTIMAL, BE COMPLETE, BE MOBILE 1 and BE MOBILE 2 ...
- Source: drugdu
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- April 30, 2023
FDA clears Pfizer’s pneumococcal vaccine for infants and children

Delilah AlvaradoAssociate Editor A general view of the Pfizer Headquarters sign on November 10, 2020 in Tadworth, England. Dan Kitwood via Getty Images Dive Brief: Pfizer on Thursday gained U.S. approval of its newest pneumococcal conjugate vaccine for use in children and infants, helping it compete with a rival shot from Merck & Co. that won a similar OK last year. Pfizer’s vaccine, called Prevnar 20, is designed to protect against infection by 20 strains of the bacteria — seven more than the company’s prior Prevnar 13 version. It has been approved in adults since 2021. Last July, Merck won approval in children of its Vaxneuvance vaccine, which protects against 15 strains. Both companies could soon face more competition as the market has sparked interest from other drugmakers. Dive Insight: While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the ...
- Source: drugdu
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- April 30, 2023
Exploring Doggybone ™ DNA Technology

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 ...
- Source: drugdu
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- April 30, 2023
In Rare Move, CMS Fines 2 Hospitals for Price Transparency Violations

The Centers for Medicare & Medicaid Services appears to be enforcing its price transparency rule more seriously. The agency recently fined two hospitals for alleged violations of the rule. Last week, CMS issued fines to Frisbie Memorial Hospital in Rochester, New Hampshire and Kell West Regional Hospital in Wichita Falls, Texas. The former was fined $102,660, and the latter received a $117,260 fine. These fines are only the third and fourth penalties issued by CMS since its price transparency rule took effect on January 1, 2021. The other two came nearly a year ago, in June 2022 — Northside Hospital in Atlanta was fined $883,180 and Northside Hospital Cherokee in Canton, Georgia was fined $214,320. CMS’ rule aims to make hospitals’ pricing data more accessible to patients so they can compare costs and make more informed decisions about the healthcare services they choose. The law requires all hospitals to post their gross charges, payer-specific negotiated charges, de-identified minimum negotiated charges, de-identified maximum negotiated charges and cash prices on their ...
- Source: drugdu
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- April 29, 2023
Quest Expands in Cancer Testing With $300M Haystack Oncology Acquisition

Quest Diagnostics is boosting its capabilities in cancer, paying $300 million to acquire a Johns Hopkins University spinout whose technology identifies cancer cells in order to guide treatment decisions. The Secaucus, New Jersey-based diagnostics giant on Thursday announced the cash acquisition of Haystack Oncology. The Baltimore-based startup is part of a growing area in cancer testing called liquid biopsies, tests that detect cancer by finding circulating tumor DNA in a patient’s blood sample. Grail and Guardant Health are among the companies that market tests that detect early signs of cancer, enabling clinicians to intervene sooner. Haystack’s focus is minimal residual disease—detecting cancer cells that remain following initial treatment with surgery or a drug. Test results help clinicians assess how well the initial treatment worked and whether additional treatment, called an adjuvant, is necessary to kill any lingering cancer cells. That’s important because additional treatment, often a chemotherapy, introduces a wide ...
- Source: drugdu
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- April 29, 2023
Do ketogenic diets elevate low-density lipoprotein cholesterol levels?

In a recent study published in the American Journal of Preventive Cardiology, researchers explored the impact of ketogenic dieting on low-density lipoprotein (LDL) cholesterol levels. Background Due to the escalating obesity levels, the ketogenic (keto) diet has been studied as a potential remedy for overweight patients’ deteriorating weight gain, cardiovascular outcomes, and insulin resistance. Though popular as a comparatively safe, non-pharmaceutical therapy, the long-term effects of the keto diet for weight loss are not fully understood, and most professional medical societies do not advise this regimen. Some individuals on a ketogenic diet may experience a significant rise in low-density lipoprotein (LDL) cholesterol levels due to its high saturated fatty acid content. About the study In the present study, researchers described a cohort of patients whose LDL-cholesterol levels rose to an unprecedented level after beginning a ketogenic diet. The team evaluated medical records of patients who ...
- Source: drugdu
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- April 29, 2023
Gut microbiome fluctuates throughout the day and across seasons, finds study

The balance of microbes in the human gut varies substantially from morning to night and even more by season—with profound fluctuations completely transforming the microbiome from summer to winter, according to a study to be presented at Digestive Disease Week (DDW) 2023. The microbiome—bacteria that live in and on the body—accounts for about half of the cells that make a human, and fluctuations in the makeup of the microbiome could have wide-ranging implications for health and medicine. “The seasonal variations we see in conditions like allergies or the flu occur in context of completely different microbiomes,” said Carolina Dantas Machado, Ph.D., the study’s lead author and a researcher in the laboratory of Amir Zarrinpar, MD, Ph.D., at University of California, San Diego. “We may need to put our understanding of how seasons affect health and disease in context of a microbiome that is much more variable and dynamic than we have ...
- Source: drugdu
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- April 29, 2023
AI breakthrough in detecting leading cause of childhood blindness

The team developed a deep learning AI model that can identify which at-risk infants have ROP that may lead to blindness if left untreated, and they hope their technique could improve access to screening in the many areas with limited neonatal services and few trained ophthalmologists. The study, by an international team of scientists and clinicians in the UK, Brazil, Egypt and the US, supported by the National Institute for Health and Care Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, is published in The Lancet Digital Health. Lead author Dr. Konstantinos Balaskas (Director, Moorfields Ophthalmic Reading Centre & Clinical AI Lab, Moorfields Eye Hospital and Associate Professor, UCL Institute of Ophthalmology) said, “Retinopathy of prematurity is becoming increasingly common as survival rates of premature babies improve across the globe, and it is now the leading cause of childhood blindness in ...
- Source: drugdu
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- April 29, 2023
Older drivers drinking or using drugs up to four times likelier to be at fault during a car crash

Substance use among older drivers increases the probability of them being at-fault two to four times during a crash, a new study, analyzing nine years’ worth of US nationwide highway traffic data, shows. Although older drivers are less likely to report using substances, this research found that out of a sample of 87,060 drivers involved in two moving vehicle crashes, more than one-third were motorists over the age of 70 who tested positive for substances. Findings are published today in the journal Traffic Injury Prevention. “In general older drivers are at an elevated risk for being at-fault in a fatal car crash, this is especially the case when they are under the influence of alcohol or drugs,” explains the lead author, Dr. Satish Kedia, a Professor at the University of Memphis School of Public Health’s Division of Social and Behavioral Sciences. In 2020, there were almost 48 million licensed drivers ages 65 ...
- Source: drugdu
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- April 29, 2023
Making young mice old in a matter of three weeks

In a paper recently published in PNAS Nexus, researchers from the Department of Comparative Biosciences at the University of Illinois Urbana-Champaign describe how they were able to inhibit the activity of a specific neuronal cell type in the hippocampus to induce cellular and behavioral changes associated with aging. Their study confirms a causal relationship between reduced function of certain interneurons in the brain and cognitive decline. In addition, their novel experimental model may be useful for studying age-related cognitive disorders. First author Jinrui Lyu, a graduate student in the Neuroscience Program and the Department of Comparative Biosciences, performed and analyzed the experiments for the study. Corresponding author Uwe Rudolph is professor and head of the Department of Comparative Biosciences in the College of Veterinary Medicine. These authors answered some questions about the design and significance of their study. What was the motivation for your study? Our lab is interested in why ...
- Source: drugdu
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- April 29, 2023

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