In The News

June 9, 2025

Regulatory News — Stakeholders urge FDA to update CGT regulations to ease path to market for promising therapies

Stakeholders say they want lower regulatory hurdles for cell and gene therapy (CGT) products, including streamlined pathways. Some researchers said updates to the US Food and Drug Administration’s (FDA) platform technology designation and designated advanced manufacturing technology programs hold the most potential to bring promising CGTs to patients. On 5 June, FDA held a roundtable…

June 5, 2025

Pink Sheet — Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

Expanded use of cost recovery “bridge” funding from the federal government could help ensure promising rare disease treatments gain US Food and Drug Administration approval and reach the market before sponsors run out of money and are forced to terminate clinical trials. The idea was floated during a recent Friends of Cancer Research meeting about cell and…

June 4, 2025

PR Newswire — Leading Health Care Groups Launch Effort to Encourage Modernization of Health Screening Measures

WASHINGTON, June 4, 2025 /PRNewswire/ — A collection of public and private sector health leaders today announced a new collaboration to help ensure current health screening measures remain aligned with the rapid advancements in FDA-approved screening technologies and clinical guidelines. The Alliance for Screening Measurement Modernization (ASMM) brings together organizations from across the healthcare sector to…

June 3, 2025

Oncology Times — The Future of Diagnostics, Artificial Intelligence & Regulatory Innovations

Consistent, accurate diagnoses are the bedrock of precision oncology. The nonprofit Friends of Cancer Research (Friends) held a meeting in Washington, DC, as part of its ongoing work to understand diagnostic test variability in support of improving precision medicine. Invited speakers and panelists probed opportunities and challenges in the use of artificial intelligence (AI), alignment…

June 2, 2025

Bioengineer.org — S2302 Pragmatica-Lung Emerges as a Model for Faster, Leaner, and More Representative Clinical Trials

In a groundbreaking advancement for clinical trial methodology, the SWOG S2302 Pragmatica-Lung trial has demonstrated an innovative approach to cancer research, challenging traditional norms with its pragmatic design and broad eligibility criteria. Launched to assess whether a combination of ramucirumab (Cyramza) and pembrolizumab (Keytruda) could improve overall survival in patients with stage IV or recurrent…

May 21, 2025

Clinical Research News — Multi-Center Study Validates AI Tools for Precision Cancer Diagnostics

A clinical research initiative has demonstrated that artificial intelligence could significantly enhance the identification of patients eligible for targeted breast cancer therapies, according to preliminary findings presented by Friends of Cancer Research. The Digital PATH Project, involving 31 contributing partners including pharmaceutical companies, academic centers, and government agencies, represents one of the most comprehensive evaluations…

May 15, 2025

Diagnostics World News — Comparison of AI Digital Pathology Tools Finds Means to Measure Performance

In a research project comparing the performance of 10 digital pathology tools capable of evaluating HER2 status from a common set of about 1,100 breast cancer samples, a key finding was the high level of agreement between their results and those of expert human pathologists—at least when the tumor marker was highly expressed. The greatest…

May 13, 2025

Agency IQ – Top cell therapy regulators discuss communications, flexibility at FOCR workshop

On May 9, the Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy hosted a public meeting focused on regulatory and manufacturing approaches to increase access to cell therapy products for small patient populations. Here, AgencyIQ provides a summary of the key points of discussion, including the FDA’s communication channels and postmarket surveillance.…

May 13, 2025

Diagnostics World – Comparison of AI Digital Pathology Tools Finds Means to Measure Performance

In a research project comparing the performance of 10 digital pathology tools capable of evaluating HER2 status from a common set of about 1,100 breast cancer samples, a key finding was the high level of agreement between their results and those of expert human pathologists—at least when the tumor marker was highly expressed. The greatest…

May 13, 2025

Roll Call — Rare Disease Patients Await Congressional Action on Life-Saving Treatments

President Trump recently signed a wide-ranging executive order urging Congress to amend a crucial provision of a Biden-era law governing Medicare drug price negotiations, with the administration’s aim being to lower prices without kneecapping pharmaceutical industry investments in the research and development of innovative new drugs. The executive order marks this administration’s first health-policy intervention…

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