WASHINGTON – During a panel discussion at the Next Generation Dx Summit this week in Washington, D.C., stakeholders from the lab and diagnostics world tackled questions around the Verifying Accurate Leading-edge IVCT Development (VALID) Act and how it could affect those industries. The bill, which would formally give the US Food and Drug Administration authority…
Anthony S. Fauci’s departure gives the Biden administration an opportunity to install the next generation of US leadership in biomedical research, but it must move swiftly with a Senate that’s losing some key NIH allies. Fauci’s plan to step down in December after more than 50 years in government marks the end of a legendary career, advising…
Multiple research studies are focusing on the use of biomarkers to detect and treat cancers at their earliest stages. The Friends of Cancer Research (Friends) has released a white paper showing the value of circulating tumor DNA (ctDNA) as a biomarker for cancer in solid tumors. While speakers at a webinar to release the paper…
Although tumor mutational burden burden (TMB) is established as a clinically informative feature of tumors, its optimal use in therapeutic decision-making faces many challenges, and we are only beginning to fully understand its strengths and limitations. Development of biomarkers that can be readily applied in the clinic to identify patients most likely to respond to…
The Regulatory Affairs Professionals Society (RAPS) recognizes 11 distinguished professionals and one patient-advocacy organization with awards for their support of the regulatory profession and work toward advancing public health. RAPS’ Founder’s Award, Community Leadership Award and Patient-Centered Health Award are presented annually during RAPS Convergence, the world’s largest conference dedicated to healthcare product regulation and regulatory…
A Friends of Cancer Research-led team reporting in JCO Precision Oncology describe circulating tumor DNA (ctDNA) changes related to clinical response in non-small cell lung cancer (NSCLC) patients receiving immune checkpoint inhibitor (ICI) treatments. Using ctDNA data and clinical profiles for 200 NSCLC patients previously enrolled in five clinical trials, the investigators reported a significant jump in overall…
In a nonmatched substudy of the phase 2 Lung-MAP trial (S1800A; NCT03971474), patients with advanced non–small cell lung cancer who have resistance to immunotherapy were treated with ramucirumab (Cyramza) plus pembrolizumab (Keytruda) vs standard of care. Investigators analyzed 130 eligible patients, with a primary end point of overall survival, and the study was implemented across…
A woman will lead the National Cancer Institute for the first time in the agency’s 85-year history, under an announcement made official by the White House on Wednesday. President Biden announced his intention to appoint Monica M. Bertagnolli, a respected cancer surgeon with posts at Harvard Medical School, Brigham & Women’s Hospital and the Dana-Farber…
The White House announcement Aug. 10 comes nearly three weeks after news of Bertagnolli’s appointment leaked out on Twitter and in the press (The Cancer Letter, July 21, 2022). “Dr. Bertagnolli lends to this effort one of the most powerful voices in the country for cancer patients, particularly for those in rural and remote communities, with a history…
Jane Henney, a former commissioner of the FDA, has been tapped by the Reagan-Udall Foundation to lead a FDA-requested external review of key agency offices on human food safety and tobacco regulation, two sources with knowledge of the matter told POLITICO. There are few details public about the foundation’s upcoming review, which is already being…
