10/12/2026  |  Moe Alsumidaie  |  The Clinical Trial Vanguard

https://www.clinicaltrialvanguard.com/opinion/phage-therapy-trials-are-launching-without-a-regulatory-playbook-thats-a-problem/ 

Picture a protocol review committee sitting down with a Phase II bacteriophage therapy submission for recurrent, multidrug-resistant urinary tract infections. The science is compelling. The unmet need is real. And then someone asks the question that nobody has a clean answer to: what goes in the comparator arm? Standard-of-care antibiotics, against which resistance is literally the reason this trial exists? Placebo, which raises obvious ethical flags when patients are suffering through their fourth infection in twelve months? The room goes quiet, because the FDA has not published a specific guidance document for bacteriophage-based therapeutics, and the field is designing its most consequential trials on instinct rather than precedent.

That regulatory vacuum is not a footnote. As JAMA’s Medical News coverage of newly launched phage therapy trials for UTIs makes clear, this therapeutic class has arrived at the clinical testing stage carrying enormous promise and an unusual amount of structural uncertainty. Globally, approximately one in six laboratory-confirmed bacterial infections were resistant to antibiotic treatments in 2023, and between 2018 and 2023, antibiotic resistance increased in over 40% of monitored pathogen-antibiotic combinations, according to WHO surveillance data. UTIs sit squarely inside that crisis. What bacteriophage therapy offers is not just another drug mechanism, it is a fundamentally different biological logic, one that the existing clinical trial infrastructure was not built to accommodate.

The Mechanism the Field Is Betting On
Bacteriophages…

10/12/2026  |  Annabel Kartal Allen  |  Clinical Trials Arena

https://www.clinicaltrialsarena.com/news/astrazeneca-efzimfotase-alfa-hypophosphatase-phase-iii-hickory/ 

Despite the primary endpoint miss, AstraZeneca hopes to bring efzimfotase alfa to patients with hypophosphatasia.

AstraZeneca’s enzyme replacement therapy (ERT) candidate, efzimfotase alfa, has failed to demonstrate significant benefits over placebo in a late-stage trial in rare bone and muscle-targeting metabolic disease, hypophosphatasia (HPP).

This late-stage miss stems from the Phase III HICKORY study (NCT06079281), in which AstraZeneca’s rare disease arm, Alexion Pharmaceuticals, pitted efzimfotase alfa against placebo in adults and adolescents with HPP. Patients enrolled in this study had not received prior treatment with Alexion’s marketed enzyme replacement therapy, Strensiq (asfotase alfa).

During the trial, efzimfotase alfa offered a 17.05-meter baseline improvement in the six-minute walk test (6MWT) after 25 weeks of treatment. However, this value failed to trump the improvements in the same endpoint attained by patients in the placebo group, resulting in the trial missing its primary endpoint. In a statement, AstraZeneca called the placebo results from HICKORY “better-than-expected.”

Despite this primary endpoint miss, a post-hoc analysis of the study did reveal that 45.2% of patients treated with efzimfotase alfa achieved a minimum clinically important difference (MCID) from baseline in the 6MWT over 30% in the placebo arm. This means that treatment with efzimfotase alfa offered a 2.5-fold higher chance of a patient receiving a clinically meaningful response in the 6MWT, when MCID is classified as 31.1 and 43-meter improvements in walking distance within adults…

10/12/2026 | Education and Era Newspaper | Vietnam.VN

https://www.vietnam.vn/pt/nha-khoa-hoc-viet-nghien-cuu-cong-nghe-phat-hien-som-ung-thu 

Vo Hong Phuc, a doctoral candidate at the University of Lübeck (Germany) and a former student at the Vietnam-Germany University, is researching PET technology for the early detection of cancer.

The turning point came during his internship.

Born in Ben Tre (formerly) and now Vinh Long, Vo Hong Phuc studied Electrical Engineering and Information Technology (EEIT), class of 2016, at the Vietnam-Germany University (Ho Chi Minh City). During his four years of college, he consistently received the VGU merit scholarship, which covered 50% of his tuition, and also won a scholarship from the German Academic Exchange Service (DAAD) to participate in a one-semester exchange program at Frankfurt University of Applied Sciences in Germany.

A turning point for Phuc occurred during his internship at a company, which shifted the focus of his research. He transitioned from pure electrical and electronic engineering to biomedical engineering, where technical knowledge can be directly applied in the healthcare field.

Determined to pursue this new field, after graduating from university, Phuc went to Germany to pursue a master’s degree in Biomedical Engineering in a joint program between the University of Lübeck and the Lübeck University of Applied Sciences, where he graduated with honors. Through his studies and thesis work, he gradually focused on nuclear medicine imaging, particularly on system simulation and the development of image reconstruction algorithms.

Continuing his scientific career, master’s student Vo Hong Phuc is a Ph.D. candidate at the Institute of Medical Technology at the University of Lübeck (Germany). He is involved in the…

10/11/2026 | Luis Salazar | Exame

https://exame.com/bussola/como-a-ia-esta-transformando-a-pesquisa-clinica-no-brasil/?utm_source=copiaecola&utm_medium=compartilhamento 

The use of artificial intelligence and data science is making drug development faster, more precise, and more inclusive throughout Brazil

The development of a new drug or vaccine is, by its very nature, a journey that requires persistence. Traditionally, the path that takes a promising molecule from the laboratory bench to the pharmacy shelf or the hospital bed is long, complex, and challenging.

However, we are witnessing an unprecedented transformation in global clinical research, driven by a force that is redefining the frontiers of science: Artificial Intelligence (AI) and Data Science.

Far from being a futuristic promise, AI already serves as an essential cog in making medical research more agile, precise, and, above all, human.

Brazil is undergoing a transformative moment in this landscape. The recent modernization of our regulatory framework, combined with the enormous diversity of our population, has strategically positioned us on the map of healthcare innovation.

At MSD, we are not merely witnessing this evolution—we are at the center of it, investing in and leading the transformation that will accelerate the delivery of new therapies to the population.

Over the past five years, we have invested more than R$ 1 billion in clinical research in the country, a reflection of our long-term commitment. Today, we are conducting more than 120 clinical studies through an extensive network that spans more than 500 research centers across all regions of Brazil.

This robust ecosystem, involving more than 3,000 patients, drives scientific progress in the country.

10/09/2026 | NSW Government/Office for Health and Medical Research

https://medicalresearch.nsw.gov.au/about/news/2026/how-aboriginal-communities-across-murrumbidgee-lhd-are-building-confidence-in-clinical-trials 

For many Aboriginal people, the term "clinical trial" can raise questions and concerns. Aboriginal Health Research Manager Lisa Curry-Lawlor, a Wiradjuri woman based in Griffith, NSW, is helping communities understand clinical trials and the importance of Aboriginal participation to help shape health outcomes.

Funded through the Rural, Regional and Remote Clinical Trials Enabling Program, Lisa works across Murrumbidgee Local Health District (MLHD) as part of the Southern Cluster. She works with Aboriginal communities, health services and researchers to help ensure clinical trials are culturally safe, respectful and focused on community priorities.

Lisa says increasing awareness begins with a simple but important message: better representation helps ensure healthcare reflects the needs of Aboriginal communities and works for more people.

"If we don't have a seat at the table, decisions are made without us," Lisa says.

Breaking down barriers

When Lisa started yarning with communities about clinical trials, she found that many people were unfamiliar with the concept or had concerns shaped by past experiences and stories passed down through generations.

"Some people thought clinical trials meant being used as a guinea pig," she says.

Lisa addresses these concerns through honest conversations, explaining clinical trials in plain language and reassuring people that participation is voluntary, informed consent is required, and participants can withdraw at any time.

The power…