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After Infant Botulism Outbreak, FDA Shares Root Cause Analysis Findings from ByHeart Formula Plants

FDA did not identify deficiencies in ByHeart’s production facilities that could explain the outbreak, but a powdered milk ingredient did test positive for C. botulinum. ByHeart is developing an action plan based on data generated from the investigations.

World-first: therapy to make cells young again trialled in a person

Boston-based biotechnology company Life Biosciences has launched the first-in-human clinical trials of a pioneering “partial cellular reprogramming” technique designed to treat optic nerve damage caused by glaucoma and NAION. Based on previous genetic research, the therapy utilizes a modified virus to deliver three youth-restoring genes to retinal cells, aiming to reverse cellular aging while preserving their specialized functions. Addressing the critical risk of inducing cancer through uncontrolled cell division, the protocol incorporates a vital safety switch: the rejuvenating genes are only activated in the presence of the antibiotic doxycycline. The eye was strategically selected for these initial trials because its relative isolation minimizes the risk of systemic, life-threatening side effects. Involving up to 12 patients, this groundbreaking study serves as a crucial test not only for the potential restoration of vision but for the safety, viability, and future reputation of partial reprogramming as a broader anti-aging and regenerative medicine therapy.


A participant in a landmark clinical trial has been given a cellular-reprogramming treatment that aims to rejuvenate damaged cells in the eye.

Reading the Galaxy’s Past

Every galaxy you’ve ever seen in a photograph is hiding something. Beyond the glowing disc of stars and gas that the camera captures lies a vast, ghostly outer region called a halo, too faint to see easily but packed with clues about how that galaxy came to be. ESA has just formally committed to a mission designed to reveal those hidden haloes in unprecedented detail, and in doing so, finally answer one of the most fundamental questions in astronomy: how did galaxies like our own Milky Way form?

Nanoparticles from tattoos circulate inside the body, study finds

The elements that make up the ink in tattoos travel inside the body in micro and nanoparticle forms and reach the lymph nodes, according to a study published in Scientific Reports on 12 September by scientists from Germany and the ESRF, the European Synchrotron, Grenoble (France). It is the first time researchers have found analytical evidence of the transport of organic and inorganic pigments and toxic element impurities as well as in depth characterization of the pigments ex vivo in tattooed tissues. Two ESRF beamlines were crucial in this breakthrough.

“When someone wants to get a tattoo, they are often very careful in choosing a parlour where they use sterile needles that haven’t been used previously. No one checks the chemical composition of the colours, but our study shows that maybe they should,” explains Hiram Castillo, one of the authors of the study and scientist at the ESRF.

The reality is that little is known about the potential impurities in the colour mixture applied to the skin. Most tattoo inks contain organic pigments, but also include preservatives and contaminants like nickel, chromium, manganese or cobalt. Besides carbon black, the second most common ingredient used in tattoo inks is (TiO2), a white usually applied to create certain shades when mixed with colorants. TiO2 is also commonly used in food additives, sunscreens and paints. Delayed healing, along with skin elevation and itching, are often associated with white tattoos, and by consequence with the use of TiO2.

The AI tools shaping patient care may be operating outside regulatory oversight. MIT researchers say it’s time to change that

Every day, across thousands of American hospitals, artificial intelligence quietly shapes decisions that determine patient outcomes. An algorithm flags a patient as high risk for sepsis; a risk score informs whether a woman receives additional cancer screening; a deterioration model triggers an alert that sends a care team to a bedside. These tools are embedded in the workflows of nearly two-thirds of US hospitals, integrated into the electronic health record systems clinicians rely on daily. But many have never been reviewed by the FDA.

A new viewpoint in The Lancet Digital Health, co-authored by researchers at MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL) and Jameel Clinic, traces how this problem took root, why it carries serious consequences, and what genuine transparency would require to fix it.

The argument, the scientists say, is not that AI has no place in clinical decision-making. It is that a $4 billion market of clinical decision support tools operates largely beyond public accountability, leaving patients and providers often unable to know whether the tools influencing their care have been validated, by whom, or for which populations they work as intended.

Long-read DNA test lifts rare disease diagnoses and could replace 15 other tests

A new test provides a much more complete picture of DNA than current standard diagnostics and leads to a diagnosis more often. The test can replace 15 other tests, making it faster and more efficient. Researchers from Radboud university medical center recommend in the New England Journal of Medicine that this test be adopted everywhere as the first choice for rare genetic disorders.

A condition is considered rare if it affects fewer than 1 in 2000 people. Nevertheless, up to 400 million people worldwide have a rare disease, as there are more than 7,000 different types. Eighty percent of these have a genetic cause. A diagnosis often takes years to obtain. Yet a diagnosis is important: It provides clarity, insight into the future, contact with others in similar situations, and the possibility to assess risks when planning to have children.

Researchers from Radboudumc and Maastricht UMC+ are working together to increase the chances of diagnosing genetic disorders. They compared current standard diagnostics—often involving multiple tests to reach a diagnosis—with a new DNA test in 1000 patients.

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