Category: In the News

To take an additional step toward harnessing real-world data to help inform the agency’s overall response to the covid-19 public health emergency, FDA has announced its participation in the Covid-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The Diagnostics Evidence Accelerator is organized by the Reagan-Udall Foundation for FDA…

The US Food and Drug Administration’s recent tissue-agnostic approval of pembrolizumab (Merck’s Keytruda) using tumor mutational burden as a predictive biomarker has sparked debate among oncologists on whether the agency made the right decision and whether the availability of another pan-cancer indication is in the best interest of patients.   The FDA last week granted…

Even as he coronavirus disease 2019 has reached global pandemic levels, the time is right to encourage community oncology practices to expand their offerings by enabling clinical trial enrollment for their patients.   “We’ve seen an expansion of telehealth capabilities and acceptance,” Howard “Skip” Burris III, MD said during the 2020 Community Oncology Conference, held…

Foundation Medicine struck a huge blow for the advancement of biomarker-driven cancer treatments last week.   The Cambridge, MA-based company won approval from FDA for FoundationOne CDx to work as a companion diagnostic that would work alongside Merck’s KEYTRUDA (pembrolizumab), an anti-PD-1 therapy. KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of…

FDA is participating in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.  The accelerator is organized by the Reagan-Udall Foundation for FDA in collaboration with Friends of Cancer Research.   “While there are current studies of viral diagnostic and antibody tests using traditional assessment methods, the Diagnostics Evidence…

Real-world evidence covers clinical insights on potential benefits or risks of a medical product taken from real-world data — information derived from registries, electronic health records, claims and billing data, as well as mobile devices and other sources that reflect patients’ actual use of products.   The need to better harness and consider those insights…

A collaboration to use real-world diagnostics evidence will seek to answer key questions about the novel coronavirus, including epidemiologic patterns, individual risk factors, and characteristics of immunity that might develop after infection with COVID-19. The Diagnostics Evidence Accelerator is a joint project between the Reagan-Udall Foundation for the Food and Drug Administration and the nonprofit…

The FDA has joined a public-private diagnostic research project with the goal of bringing more real-world data to bear against the novel coronavirus, and gauging the accuracy of different kinds of tests.   Formed by the Reagan-Udall Foundation and Friends of Cancer Research, the COVID-19 Diagnostics Evidence Accelerator will work to collaborate with test manufacturers,…

Executive Summary Principal Deputy Commissioner Amy Abernethy suggests FDA may clear a COVID-19 vaccine on smaller than usual clinical datasets and rely on real-world data to fill in the gaps. Abernethy said a new public-private partnership is starting to explore how it can use real-world data and evidence for COVID-19 vaccine evaluation. The US Food…

The remote monitors and telehealth check-ins made necessary by the coronavirus could become permanent fixtures of new clinical trials going forward, FDA Commissioner Stephen Hahn said.   The pandemic has delayed or even stopped clinical trials unrelated to Covid-19, including a study testing a Novartis AG cholesterol drug. It has also forced doctors to rely…