Responding to COVID-19 is forcing regulators, medical product developers and health systems to get real about real-world data and evidence as they reach for every available tool to learn about the disease and speed the development of effective interventions. Amy Abernethy, FDA’s principal deputy commissioner and acting CIO, and Mark McClellan, director of the…
Senators Edward J. Markey (D-MA) and Thom Tillis (R-NC) and 31 of their Senate colleagues are calling for protections for the U.S. scientific research community during the coronavirus pandemic. Although novel coronavirus-related research is a current federal government priority, most other research has slowed or stopped due to closures of campuses and laboratories. The…
Life won’t completely return to normal while the novel coronavirus remains a threat to health and to life. More than 60,000 Americans have already lost their lives to this virus; while older people seem especially vulnerable, the virus has demonstrated its ability to kill people of all ages. Even as the country edges back to…
Investigators from the non-profit Friends of Cancer Research (FOCR)’s tumor mutational burden (TMB) harmonization project shared new data this week from their second phase in which they continue to investigate how available assays differ in their results when applied to the same samples and experiment with methods to harmonize tests to a common reference standard.…
Patients with cancer and those who have recently completed treatment are finding it challenging to get necessary health care in the midst of the COVID-19 pandemic, and many are experiencing financial stress trying to afford care in an increasingly difficult economic environment. Delays in Care According to the latest survey from Survivor Views—a national cohort…
Can patients with cancer and preexisting autoimmune disorders safely benefit from immunotherapy? The answer has been unclear, with only retrospective studies and anecdotal reports guiding oncologists. This subpopulation of patients has largely been excluded from clinical trials out of concerns over the risk of severe immune-related adverse events or worsening of their underlying disease. “As…
Executive Summary Agency is going outside its ‘comfort zone’ to leverage different streams of existing real-world data sources to quickly assess the impact of potential treatment approaches, Amy Abernethy says; pandemic experience could lead to a more open embrace of RWE beyond the current public health emergency. The COVID-19 pandemic is forcing the US Food…
The first look at how well Gilead’s Ebola drug treats Covid-19 patients in an NIH clinical trial should come in a matter of weeks, the agency’s head said Monday. If available, that initial analysis would come a little more than two months after the trial began. It’s also the first wave in a deluge…
The US Food and Drug Administration last week issued a guidance intending to ease patient access to precision oncology drugs by outlining how test developers may achieve broader companion diagnostic indications. The guidance is perhaps a bit late coming. After all, it has been long known that the one drug/one test paradigm is outdated…
If Merck is successful in garnering US Food and Drug Administration approval for pembrolizumab (Keytruda) in advanced cancer patients with high tumor mutational burden, it will be the second pan-cancer indication for the drug. This will allow Merck, which recorded pembrolizumab sales of $11.1 billion last year, to make the drug available to more…
