In The News

February 11, 2025

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…

February 4, 2025

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…

January 30, 2025

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…

January 27, 2025

Mass Device — FDA Selects a CDRH Official as Acting Commissioner

Dr. Sara Brenner, who has been FDA CDRH’s in vitro diagnostics chief medical officer, is serving as acting commissioner of the agency. That’s according to a recent update to the agency’s leadership profiles. The FDA, which has been under a communications freeze under the new Trump administration, did not immediately respond to MassDevice requests for…

January 24, 2025

Regulatory Focus — This Week: Trump Signs Slew of EO, Appoints New Officials at FDA

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, President Donald Trump took office and wasted no time signing a slew of executive orders that significantly affect the…

January 24, 2025

The Cancer Letter — Janet Woodcock, Paul Kim join Friends’ board of directors

Janet Woodcock, former director of the Center for Drug Evaluation and Research at FDA, and Paul T. Kim, principal of Kendall Square Policy Strategies LLC, were appointed to the board of directors at Friends of Cancer Research. Woodcock has been an advocate and ally for Friends for over 25 years. Most recently, Woodcock served as…

January 21, 2025

BioCentury — Fabrice Chouraqui to become CEO of Pharming

Fabrice Chouraqui will become CEO of Pharming Group N.V. (Euronext:PHARM) pending the approval of the company’s shareholders at a March 4 extraordinary meeting. Chouraqui, a CEO-partner of Flagship Pioneering, will succeed Sijmen de Vries if approved. Friends of Cancer Research appointed FDA veteran Janet Woodcock and attorney Paul Kim to its board. Woodcock was most…

January 10, 2025

MEDPAGE — Future of Lab-Developed Tests Still Taking Shape

As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs) is one of many issues that health advocates and lobbyists will be watching closely. LDTs are — as the name implies — clinical tests developed by individual labs in doctors’ offices and hospitals to be used…

January 10, 2025

Fierce Pharma — FDA’s Patrizia Cavazzoni to retire as CDER chief in 2nd senior official’s departure in span of weeks

The FDA’s influential director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., will soon retire from the agency. The seven-year FDA veteran communicated the decision in an internal communication viewed by Fierce Pharma. Her last day will be Jan. 18. “Leaving CDER was an extremely difficult decision, but the time has come…

January 8, 2025

MEDPAGE TODAY — Hillary Andrews on the Need to Standardize HRD Assays in Ovarian Cancer

Assays to measure homologous recombination deficiency (HRD) in ovarian cancer vary widely, underscoring the need for standardization, since inconsistent assay results can influence treatment decisions. Patients with high-grade serous ovarian cancer (HGSOC) with HRD tumors have better outcomes when treated with PARP inhibitor maintenance therapy. Nearly half of patients with HGSOC have HRD, and approximately…

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