In The News

April 8, 2026

Inside Health Policy — Haystack Project Petitions FDA To Adopt Context-Driven Evidence Approach For Rare Therapies

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…

April 2, 2026

Oncology Times — Promise of AI & Circulating Tumor DNA for Patients

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…

March 24, 2026

CancerNetwork — The Evolution of Artificial Intelligence in Oncology: Impact on Trials, Workflows, and Outcomes

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…

March 12, 2026

ASCO: AI in Oncology — HER2 Scoring Interpretation Concordance Across Computational Pathology Models

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,…

March 9, 2026

AgencyIQ — UniQure controversy, Prasad exit leave rare disease field wondering where FDA stands

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…

March 4, 2026

Precision Medicine Online — Former FDA Officials Express Concerns Around Remaining Expertise, Political Influence at Agency

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…

March 3, 2026

PharmaBoardroom — Jeff Allen – CEO, Friends of Cancer Research

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…

February 23, 2026

360Dx — Panakeia’s AI Tech Shows High Agreement With Molecular Tests in Colorectal Cancer Validation Study

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,…

February 23, 2026

BioCentury — Gilead’s Arcellx buy. Plus: ctDNA as surrogate endpoint — a BioCentury podcast

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…

February 20, 2026

The Cancer Letter – At Friends meeting, Pazdur, Woodcock lament FDA’s failure to protect the agency staff from political interference, warn of “lasting implications”

For decades, FDA commissioners sought to insulate the agency’s professional staff from political interference with regulatory decisions. Today, this guardrail appears to have been removed, two former agency officials said at a recent meeting of Friends of Cancer Research. The Feb. 5 meeting, “Modernizing Endpoints: Pathways for Evidence and Policy,” featured a fireside discussion with…

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