06/23/2026  |  Andy Studna  |  Applied Clinical Trials

https://www.appliedclinicaltrialsonline.com/view/hhs-operation-trialblazer-us-leadership-clinical-research 

A coordinated department-wide initiative combines FDA regulatory reforms, NIH investments, and new agency programs to reduce development timelines and reverse a growing shift of clinical research overseas.

The US Department of Health and Human Services (HHS) has announced Operation TrialBlazer, a coordinated effort across multiple federal agencies aimed at strengthening the United States' position as the global leader in clinical research.1

The initiative combines regulatory reforms at the FDA, new National Institutes of Health (NIH) investments, and programs across several HHS agencies, all focused on reducing unnecessary barriers and accelerating the path from drug discovery to patient access.

According to an article in The Hill, China surpassed the US in total clinical trials registered for the first time in 2024, accounting for 39% of global trials. China's Phase I trial share overtook the US as far back as 2021, driven by lower costs, streamlined regulation, and government subsidies that are difficult for other countries to match.2

"America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas," said HHS Secretary Robert F. Kennedy Jr. in a press release. "HHS is launching a coordinated department-wide effort to restore America's leadership in clinical research, remove unnecessary barriers, and bring more clinical research and investment back to the United States."

Acting FDA Commissioner Kyle Diamantas framed the stakes similarly. "We've been witness to a growing share…

06/23/2026  |  Marie Bentley  |  Black Doctor

https://blackdoctor.com/alzheimers-disease-clinical-trials/ 

This Study Could Offer Hope to Black Americans with Alzheimer's and Other Major Brain Diseases Alzheimer’s disease is the most common neurodegenerative disorder in the world. The Centers for Disease Control and Prevention (CDC) estimates that 6.7 million Americans live with Alzheimer’s in the United States. Twenty-one percent of Black Americans over the age of 70 have Alzheimer’s disease, and older Black Americans are twice as likely as their white counterparts to have Alzheimer’s or another type of dementia.   

“Alzheimer’s disease is the most common form of dementia,” said Shardae Showell, PhD, Medical Director, Clinical Development, Alzheimer’s & Dementia at Biogen. “It is a progressive neurological disorder that gradually damages the brain, leading to memory loss, confusion, and difficulty with thinking and daily activities.”

Dr. Showell explained that their goal at the 2024 Alzheimer’s Association International Conference (AAIC) was to present new data to foster dialogue within the community to support “enhancing the inclusion of underrepresented populations in Alzheimer’s disease clinical trials.”

What Are Clinical Trials? 
Clinical trial research is imperative for developing new treatments for diseases, as it provides crucial data necessary for drug and treatment approval. They allow eligible patients to receive treatments they would otherwise be unable to access. 

Clinical trials progress in three main phases. Phase I trials focus on the safety and dosage of a treatment within a small group of participants. In Phase II, larger groups of participants – typically between 50 and…

06/23/2026  |  Clinic Barcelona

https://www.clinicbarcelona.org/en/news/rethinking-alzheimer-s-clinical-trials-to-include-atypical-forms-of-the-disease?from=research 

A paper published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association examines the limitations of current clinical trials in Alzheimer’s disease and proposes ways to better adapt them to the clinical diversity of the condition.

The study, which involved several international research centres, was coordinated by Dr Neus Falgàs, researcher in the Alzheimer’s disease and other cognitive disorders group at IDIBAPS and a member of the Alzheimer’s Unit at Hospital Clínic, together with Dr Nick Corriveau-Lecavalier, from the Department of Neurology at Mayo Clinic. Dr Rema Raman, from the University of Southern California, is the senior co-author of the study. From Clínic-IDIBAPS, Dr Albert Lladó, head of the Alzheimer’s Unit, also contributed to the work.

A heterogeneous disease beyond memory loss
Alzheimer’s disease is commonly associated with progressive memory loss, particularly in older adults. However, this is not always how the disease begins. In some cases—especially in individuals under 65—the earliest symptoms may affect other cognitive domains, such as language, vision, executive function or behaviour. These presentations, known as atypical variants, usually progress to a more generalized cognitive decline that also includes memory impairment.

These variants show distinct clinical profiles and patterns of brain involvement and may be associated with a faster progression. They often affect individuals during their working years and with family responsibilities,…

06/23/2026  | Wallace Graciano  |  O Tempo

https://www.otempo.com.br/politica/2026/6/23/anvisa-cancela-seis-pesquisas-clinicas-a-pedido-de-empresas 

The Brazilian Health Regulatory Agency (Anvisa) has officially withdrawn six applications related to clinical trials of drugs in Brazil. The decision was published via Resolution RE 2,503, dated June 22, 2026, in Monday’s edition of the Federal Official Gazette (DOU).

The measures respond to requests made by the manufacturers themselves, who decided to halt the progress of their applications with the federal agency’s Coordination of Clinical Research on Medicines and Biological Products. Among the affected companies are the pharmaceutical firms EMS, Apsen, and Janssen-Cilag.

In practice, the resolution means that studies for the development of new synthetic drugs or modifications to products already under investigation have been shelved. Since the research was still in the administrative review or technical execution phase, there is no direct impact or risk to those who already use drugs from these brands in the domestic market.

List of Canceled Applications
O TEMPO’s investigation found that the measure covers the following approval applications (official authorization to conduct research) and dossiers:

• EMS S/A — approval application for a Drug Clinical Development Dossier (DDCM) for a synthetic drug and approval application for a clinical research protocol for synthetic drugs.
• Apsen Farmacêutica S/A — three approval applications for Drug Clinical Development Dossiers (DDCM) for synthetic drugs.
• Janssen-Cilag Farmacêutica Ltda — application for modification of the product under investigation in a clinical trial.

What…