Clinical Research Focus. 14th Edition
Clinical Trials in Romania – So Much to be Discovered
With a growing population of 19.4 million people, Romania is the twelfth-largest country in Europe and the seventh-most populous member state of the European Union. With its clinical research activity on the rise, it is currently home to more than 500 clinical trials.
In recent years, Romania has become a popular destination for international pharmaceutical companies seeking to conduct clinical trials in Europe. Romania has a well-developed healthcare system, well-trained investigators, a favorable regulatory environment, and a diverse patient population that is eager to participate in clinical research.
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EMA Issues Human Medicines Highlights 2022 Report
The European Medicines Agency (EMA) has released a report containing its Human Medicines Highlights 2022. The focus is the overview of the agency’s key recommended medicines in 2022. Last year, the EMA has issued positive opinions on 89 medicines and recommended them for marketing authorization. Out of the 89 medicines, 41 had a new active substance which hasn’t been previously authorized in the European Union (EU). Only 3 negative opinions were issued and 16 applications were withdrawn by the sponsors. The report addresses medications that have made a significant contribution to the development of treatments in the following therapeutic areas: oncology, hematology, metabolism, neurology, and pulmonology.
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Engineering Skin Grafts for Complex Body Parts
A research team from Columbia University led by Dr. Hasan Erbil Abaci, has been working on approaches to make 3D engineered skin grafts in the shape of complex body parts. Until now, the available techniques have only permitted skin patches to be produced in forms similar to bandages. Using patches on complex structures like hands demands extensive cutting and suturing, which can cause additional damage. Additionally, 3D-cultured skin was more resistant to stresses produced by movement. In a new study, the team tested their skin-culture system using cultured 3D grafts in the shape of the skin on mouse hindlimbs. Transplanting these ready-made grafts to injured mouse legs took less than 10 minutes. The mice regained full functioning of their legs within four weeks.
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Blood Biomarker May Enable Early Diagnosis of Vascular Dementia
Vascular dementia is the second most common type of dementia, responsible for 5–10% of dementia cases. Placental Growth Factor, or PlGF, one of a group of proteins called vascular endothelial growth factors, is involved in angiogenesis, the development of new blood vessels from existing ones. The researchers theorized that the body could respond to damaged small blood vessels in the brain with increased efforts to develop further. In a study lead by University of California, Los Angeles (UCLA) and four other sites, 335 patients underwent brain imaging, cognitive testing, and blood collection. Those in the top quartile for PlGF measurement were three times as likely to have cognitive impairment or dementia compared to those in the bottom quartile. Additional studies to determine whether PlGF and other angiogenic bloodstream markers could help predict the risk of future cognitive decline are now ongoing.
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FDA Approves First Treatment for Geographic Atrophy
SYFOVRE (pegcetacoplan injection) is the first-ever treatment for geographic atrophy (GA), an advanced form of age-related macular degeneration, that was approved by the US Food and Drug Administration (FDA). GA is the leading cause of blindness. This approval of a new treatment is possibly the most important event in retinal ophthalmology in more than a decade. Based on the results of OAKS (n=637) and DERBY (n=621) Phase 3, multicenter, randomized, double-masked, sham-controlled trials,this treatment will help people with GA prevent continuous vision loss.
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Covid-19 Emergency Declaration Will End in May
US President, Joe Biden, announced that the country will end the Covid-19 emergency declaration in May this year. According to GlobalData, there are 680 clinical trials on Covid-19 that are currently in the planning stage. Sponsors developing injectable Covid-19 vaccines might be compelled to stop the research. The end of the emergency declaration may also mean the end of governmental funding for drug and vaccine developers. It is also unclear how this will affect the Emergency Use Authorisations (EUAs). However, not all scientists agree that the development of drugs against Covid-19 should be suspended. “Developers need to shift their focus to discovering stronger and more stable vaccines or therapeutics that would be able to adapt to the changes of the virus”, said Rodney Rohde, PhD, Chair and Professor at the Clinical Laboratory Science Program at Texas State University.
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De Novo Enzymes That Speed Up Chemical Reactions Created with The Help of Deep Learning
For the first time Machine Learning was used to create brand-new enzymes, proteins that accelerate chemical reactions. A research team from the Institute for Protein Design at UW School of Medicine developed machine learning algorithms that can create light-emitting enzymes, luciferases. “We were able to design very efficient enzymes from scratch on the computer, as opposed to relying on enzymes found in nature. This breakthrough means that custom enzymes for almost any chemical reaction could, in principle, be designed,” said the head of the project, postdoctoral scholar Andy Hsien-Wei Yeh.
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