In The News

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…

May 6, 2025

Bloomberg Law – Rare Disease Industry Awaits FDA Chief’s New Drug Pathway Plan

FDA Commissioner Marty Makary’s proposal to roll out a new drug approval pathway is heightening hope for the rare disease industry, but attorneys say implementation may face challenges for spurring rare drug development. Makary outlined on the Megyn Kelly Show in April a plan to approve drugs for rare conditions based on a “plausible mechanism,” allowing medicines…

April 25, 2025

Cure – ctDNA Clearance Linked to Improved Survival in Oncogene-Driven NSCLC

Among patients with oncogene-driven advanced non–small cell lung cancer (NSCLC) who were treated with tyrosine kinase inhibitors (TKIs), improved survival end points were associated with circulating tumor DNA (ctDNA) clearance within 10 weeks of treatment initiation, according to findings published in AACR Journals. This means that patients undergoing TKI treatment for their lung cancer, which is…

April 24, 2025

ADLM – CLN Article District court strikes down the FDA’s final laboratory developed tests rule

It was great news for clinical labs when a federal district court decided on March 31 to vacate the Food and Drug Administration’s (FDA’s) final rule that would have given the agency power to regulate laboratory developed tests (LDTs). The rule would have greatly increased regulatory requirements for labs offering LDTs. The decision in the…

April 23, 2025

Biodesix – Biodesix partner, Friends of Cancer Research, publishes data in Clinical Cancer Research, demonstrating strong association between ctDNA changes and treatment outcomes for patients with solid tumor types

Biodesix, Inc (Nasdaq: BDSX), a leading diagnostics solutions company, and Bio-Rad Laboratories (NYSE: BIO), a global leader in life science research and diagnostics products, contributed to new research findings from Friends of Cancer Research’s (Friends’) ctMoniTR Project, recently published in Clinical Cancer Research (CCR). The findings demonstrate a strong association between changes in levels of circulating tumor DNA (ctDNA)…

April 22, 2025

Pink Sheet – Confirmatory Trials: Industry Wants Timely Protocol Feedback, More Clarity On ‘Due Diligence’

Industry comments on two recent US Food and Drug Administration guidance documents on accelerated approval seek clear timelines for agency feedback on confirmatory study protocols and a better understanding of how the FDA defines “due diligence” for purposes of timely study conduct. Industry stakeholders also seek assurances that the FDA will be flexible in deciding…

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