Clinical Research Focus. 42nd Edition

EMA Recommends Conditional Approval of Zemcelpro for Blood Cancer Patients Lacking Donors

The EMA has recommended conditional marketing authorisation for Zemcelpro, a novel stem cell therapy developed to support patients with blood cancers who require a stem cell transplant but lack a suitable donor. By expanding umbilical cord blood cells, Zemcelpro aims to improve engraftment outcomes in high-risk patients. Backed by the EMA’s PRIME scheme, this first-in-class therapy addresses a critical unmet medical need in hematological malignancies.

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Post-ASCO 2025 Insights: What Oncology Sponsors Need to Know

From AI-assisted biomarker diagnostics and mutation-driven therapies to MRD-based trial designs and evolving immunotherapy standards, ASCO 2025 delivered powerful insights for sponsors navigating today’s complex oncology landscape. Cromos Pharma breaks down 10 strategic takeaways that could shape your next trial.

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FDA Unveils Elsa: AI Tool to Accelerate Reviews and Boost Operational Efficiency

The FDA has officially launched Elsa, a secure, agency-wide generative AI assistant built to streamline internal workflows—from clinical protocol reviews to safety assessments and database creation. Developed in a high-security GovCloud environment, Elsa marks the beginning of FDA’s broader AI strategy to modernize regulatory processes while safeguarding sensitive data. Here’s what this rollout means for the future of regulatory science.

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Five Proven Strategies to Boost Patient Recruitment in Clinical Trials

Patient recruitment remains one of the toughest hurdles in clinical research. In this short video, our Senior CRA, Tihomira Leteyski, shares five practical strategies we use at Cromos Pharma to help sites overcome key barriers – from strict eligibility criteria to underused referral networks.

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Vertex Unveils Promising Data for Zimislecel in Type 1 Diabetes at ADA 2025

At the 85th Scientific Sessions of the American Diabetes Association, Vertex presented compelling results from its zimislecel clinical trial—an investigational stem cell-derived islet cell therapy for type 1 diabetes. All 12 patients who received a full dose achieved target HbA1c and time-in-range levels, with 83% becoming insulin-independent. The data were also published in the New England Journal of Medicine.

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Key Takeaways from BIO 2025: What’s Next for Biotech and Clinical Trials

Fresh from the halls of BIO 2025 in Boston, Cromos Pharma’s Business Development Director Nicole Brenna shares key insights on where biotech is heading—from AI-driven drug development to smarter clinical trial strategies and a renewed focus on execution. After four dynamic days of meetings, panels, and trendspotting, Nicole offers a clear perspective on what sponsors need from their CROs today—and why it matters now more than ever.

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NIH Identifies Brain Circuits Crucial for Visual Acuity – A New Frontier in Vision Restoration

In a breakthrough study, NIH researchers have pinpointed specific brain circuits responsible for visual sharpness and revealed how they are affected by retinal cell damage. The findings suggest that future vision restoration therapies—beyond repairing the retina—may need to target downstream brain pathways to fully restore sight. This research could also inform treatment strategies for neurological conditions with visual deficits, such as schizophrenia.

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AI Model GRAPE Shows Breakthrough Accuracy in Gastric Cancer Detection Using Routine CT Scans

A new AI-powered tool, GRAPE, has demonstrated exceptional accuracy in detecting gastric cancer from noncontrast CT scans, outperforming radiologists and identifying early-stage cases that were previously missed. Validated across 78,000+ real-world cases, this scalable, noninvasive screening approach could transform gastric cancer detection in resource-limited settings and beyond.

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Eli Lilly Pursues Approval for Once‑Weekly Insulin After Strong Phase III Trial Results

Eli Lilly is set to approach global regulators seeking approval for efsitora alfa, its once‑weekly basal insulin for type 2 diabetes. The drug demonstrated non‑inferior HbA1c reduction compared to daily basal insulin therapies across three pivotal QWINT trials, while also reducing hypoglycemic events and offering a simpler dosing schedule—potentially replacing hundreds of daily injections for patients.

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Roche to Launch Phase III Trials of Parkinson’s Antibody Prasinezumab Despite Earlier Failures

Roche, in partnership with Prothena, is advancing prasinezumab—a monoclonal antibody targeting α-synuclein—into Phase III trials for early-stage Parkinson’s disease. The decision comes despite two mid-phase trials failing to meet primary endpoints, as Roche remains “encouraged by the efficacy signals” suggesting delayed symptom progression such as tremors and stiffness. The move underscores a strategic pivot to explore disease-modifying potential despite earlier setbacks.

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