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Category: In the News

ReachMD – Revolutionizing Metastatic Cancer Surveillance with ctDNA Concentration Thresholds

Harnessing Absolute ctDNA Measurements for Early Detection of Cancer Progression Recent studies indicate that measuring the absolute concentration of circulating tumor DNA (ctDNA) in patients with metastatic cancer can serve as a crucial predictive biomarker for imminent disease progression, paving the way for more timely clinical interventions. A breakthrough in metastatic cancer management has emerged…

The ASCO Post – Lung-MAP 3.0: Simplifying the Process to Meet Patients’ Needs

The Lung Cancer Master Protocol (Lung-MAP) is an innovative clinical trial designed to efficiently address the unmet needs of patients with advanced non–small cell lung cancer (NSCLC) following front-line therapy. This pioneering effort was the first biomarker-driven umbrella master protocol initiated by the National Cancer Institute (NCI), the NCI’s National Clinical Trials Network led by SWOG…

Healthcare Innovation – Federal Workers Protest HHS Staffing Cuts in Front of HHS Headquarters

On Feb. 19, crowds of former and current staffers at the Department of Health and Human Services protested outside the agency’s headquarters in Washington, D.C. As ABC News’s Hannah Demissie and Selina Wang reported on Wednesday, “Bracing the frigid temperatures, crowds of former and current federal workers protested the deep cuts to the Department of…

The Washington Post – Trump’s firings strike the nation’s health agencies

The nation’s health agencies were upended over the weekend by a confusing, slow-motion rollout of terminations that left staff worried about the future of various projects, including those to improve maternal health, discover new cancer treatments and provide help for 9/11 responders. Several thousand probationary employees across the Department of Health and Human Services were…

Fortune – DOGE reportedly fired the FDA employees who were reviewing clinical trials for Elon Musk’s Neuralink

The Department of Government Efficiency has reportedly eliminated the jobs of those overseeing Elon Musk’s brain implant company Neuralink within the Food and Drug Administration, as part of President Donald Trump’s mass culling of government jobs. The firings over the weekend included about 20 employees who were part of the FDA’s office of neurological and…

Us Against Alzheimer’s – Coalition of Groups Representing Tens of Millions of Patients Calls for Protection of the Nation’s Vital Health Infrastructure

 A broad coalition of patient organizations today issued the following statement in response to cuts in staff, and research funding at federal agencies vital for American health. “Nearly every American family is affected by one or more of the diseases represented by our groups, and the stakes could not be higher. The United States is…

Inside Health Policy – HHS Agencies Begin Layoffs Affecting Thousands Of Probationary Staff, Unions Vow Legal Action

Unions representing federal government workers vowed legal action over major cuts to probationary staff across the government Friday (Feb. 13), including at HHS subagencies, though it’s still unclear precisely how many staff are affected at each subagency. The layoffs are expected to impact about 5,200 probationary employees across HHS, a source told Inside Health Policy, but…

Agency IQ — Flexible frameworks for rare disease diagnostics development: Will it be enough?

At a recent meeting hosted by the Friends of Cancer Research, experts from industry talked through next steps for development of companion diagnostics for rare diseases, including in oncology. The ideas come as FDA’s diagnostics regulatory reforms face an uncertain future with the new administration and agency staffing changes. Introduction: FDA’s diagnostics regulatory reform and…

BostonGene — BostonGene Contributes to Friends of Cancer Research White Paper Introducing a Novel Process for Companion Diagnostics for Rare Biomarkers and Indications

BostonGene Drives Innovation in Rare Cancers Through Cutting-Edge AI-powered Diagnostics and Collaborative Research BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, is proud to announce its contributions to a white paper with Friends of Cancer Research entitled “Innovative Validation and Regulatory Processes for Companion Diagnostic Tests for Rare Biomarkers or Indications.” The…

Healio — Decentralized Clinical Trials: FDA Guidance and the ‘New Modus Operandi’

Key takeaways: FDA issued guidance on decentralized elements of clinical trials last fall. Investigators need to balance using decentralized elements and limiting data variability. The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to continue their research. The FDA provided recommendations to investigators during the pandemic about how to…