May 15, 2025
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April 8, 2026
External control arms can make clinical trials feasible in rare and serious conditions, but the approach comes with operational, statistical and regulatory challenges. At a Friends of Cancer Research workshop this week, stakeholders discussed the output of a comparative pilot project and approaches to tackle issues such as data missingness. Background and context: External control…
Read MoreApril 8, 2026
A rare disease advocacy group is petitioning FDA to fundamentally rethink how it evaluates therapies for small patient populations, submitting a formal petition that urges a more context-driven approach to evidence generation that acknowledges randomized controlled trials may not always be a suitable approach, even as agency officials say the push toward patient-centered endpoints is…
Read MoreApril 2, 2026
The Friends of Cancer Research (Friends) held a conference in Washington, DC, to focus on new findings from two of its research projects, ai.RECIST and ctMoniTR. “Today’s discussion is about one thing above all: patients,” said Ellen V. Sigal, PhD, Friends Founder and Chairperson. She stressed that patients need to know their tests are accurate…
Read MoreMarch 24, 2026
Specialized LLMs, AI-assisted CT scans for early detection, and foundational models democratizing pathology are among emerging technologies in oncology care. Artificial intelligence (AI) has been utilized in a variety of capacities to fundamentally transform oncology care since its inception. Technology that initially started out as a “hallucination-prone punch line” per Matthew Matasar, MD, chief of…
Read MoreMarch 12, 2026
Scoring of HER2 expression levels showed strong agreement across 10 computational pathology AI models in identifying cases of HER2 3+ in whole-slide images from patients with breast cancer. Greater variability, however, was seen in borderline categories such as HER2-low expression. These findings, which demonstrate a need for greater tool refinement to improve reproducibility, especially in low-intensity settings,…
Read MoreMarch 9, 2026
A dispute over an experimental Huntington’s disease treatment has escalated concerns over the FDA’s decision-making on rare disease drugs. The departure of Center for Biologics Evaluation and Research Director VINAY PRASAD, whose office handled discussions with the treatment’s developer uniQure, could deepen uncertainty over how the FDA is applying promised flexibility. The FDA, uniQure and…
Read MoreMarch 4, 2026
Former US Food and Drug Administration officials are worried that the loss of long-standing institutional expertise and politically influenced decision-making at the agency under the Trump Administration could tarnish the regulator’s reputation as a leader in cutting-edge science. Janet Woodcock, who served as the agency’s principal deputy commissioner from 2022 to 2024 and in multiple…
Read MoreMarch 3, 2026
Jeff Allen is the President & CEO of Friends of Cancer Research, a research policy and advocacy organisation based in Washington, DC. His organisation works to accelerate the development of cancer therapies through evidence-based policy and collaborative research partnerships. Allen highlights the importance of diagnostics and biomarker testing to help inform patient care and support…
Read MoreFebruary 23, 2026
British omics startup, Panakeia, said it has validated its artificial intelligence-based technology, which it is hoping will one day bypass conventional wet lab tests to identify biomarkers from images of biopsy slides. Panakeia has evaluated the performance of PANProfiler Colorectal using imaging and clinical data from colorectal cancer patients treated at the University of Leeds,…
Read MoreFebruary 23, 2026
Gilead is acquiring Arcellx for $7.8 billion up front three years after forging a partnership with the biotech around a cell therapy for multiple myeloma. On the latest BioCentury This Week podcast, BioCentury’s analysts assess what the deal does for the Foster City, Calif.-based biotech’s pipeline. The analysts also discuss the case for using ctDNA as a surrogate endpoint…
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