Clinical Research Focus. 55th Edition

BIO 2026: Five Industry Shifts That Will Shape Clinical Development Over the Next Few Years

BIO 2026 made one thing clear: the future of clinical development will be defined not only by scientific innovation, but by global execution. In our latest article, Nicole Brenna shares five major industry shifts, including AI, regulatory change, and China’s rise as an innovation leader, that sponsors should be watching.

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FDA Selects First Participant for TEMPO Digital Health Pilot

The FDA has selected the first participant for its TEMPO Digital Health Devices Pilot, a new initiative designed to generate real-world evidence and accelerate the adoption of digital health technologies. The program could shape future regulatory pathways for digital health and chronic disease management.

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The $137 Billion Wake-Up Call: What Operation TrialBlazer Really Changes for Sponsors

Operation TrialBlazer could reshape how clinical trials are designed and reviewed in the US. From earlier FDA engagement and more flexible evidence requirements to real-time data sharing, the initiative aims to accelerate clinical development without lowering regulatory standards. But faster regulatory pathways only deliver value if operational execution can keep pace. In our latest article, we explore what these proposed changes mean for sponsors and why operational readiness will matter more than ever.

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EMA Recommends First Oral IL-23 Therapy for Plaque Psoriasis

The EMA has recommended approval of Icotyde, the first oral therapy targeting the IL-23 pathway for moderate-to-severe plaque psoriasis. Backed by Phase 3 data involving 2,500 patients, the treatment demonstrated high rates of skin clearance while offering a convenient oral alternative to injectable biologics.

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New Blood Test Could Predict Alzheimer’s Symptoms Years Before They Appear

Researchers have identified a new blood-based biomarker that may predict the onset of Alzheimer’s symptoms two to four years before cognitive decline begins. Based on circular RNAs (circRNAs), the approach outperformed one of today’s leading Alzheimer’s blood biomarkers in forecasting disease progression, potentially improving patient selection for clinical trials and enabling earlier intervention.

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US House Advances Shift Toward Nonanimal Drug Testing

The US House has passed the FDA Modernization Act 3.0, a bill directing the FDA to update outdated animal testing regulations and further support the use of validated nonanimal methods in drug development. The move could accelerate the adoption of more modern preclinical approaches.

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Lilly Reports Two More Successful Phase 3 Trials for Retatrutide

Eli Lilly has announced positive results from two additional Phase 3 trials of its investigational triple agonist retatrutide. The therapy delivered up to 22.6% weight loss while significantly improving HbA1c in adults with obesity and type 2 diabetes, further strengthening its position among the next generation of obesity treatments.

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Genetic Signals Could Help Predict CAR-T Toxicity

Researchers have identified genomic markers linked to both the effectiveness and toxicity of CAR-T cell therapy in lymphoma patients. The findings could help improve patient selection, predict severe side effects, and support more personalized treatment strategies.

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