President Biden on Friday nominated former Food and Drug Administration commissioner Robert M. Califf to return as the agency’s head, ending a difficult, months-long search to find a leader for the sprawling bureaucracy on the front lines of the coronavirus pandemic. In a statement, Biden said Califf “has the experience and expertise to lead the…
President Joe Biden has nominated former Commissioner Robert Califf to lead the Food and Drug Administration Friday, in a move that would bring the Obama-era official back for a second tour atop the agency. The selection would end the administration’s lengthy search for a permanent FDA commissioner and comes as the agency weighs a series…
Friends of Cancer Research is calling on all stakeholders in the cancer community to move away from the idea of “more is better” in drug dosing and begin to incorporate dose-finding studies into the cancer trial process. Dose optimization is the focus of a new white paper that the group released at its 25th annual meeting. The…
A newly released white paper from the Friends of Cancer Research calls for a collaborative effort to investigate the use of circulating tumor DNA (ctDNA) as an “early endpoint” to predict long-term cancer survival outcomes in early-stage cancers. This type of early endpoint could be used by regulators when considering certain accelerated cancer approvals.…
The FDA’s breakthrough therapy designation (BTD) for expedited drug approval has been a boon for cancer patients. According to data presented at a webinar sponsored by the Friends of Cancer Research (Friends), since 2012 the FDA has received more than 1,000 requests for BTD from drug sponsors, granting more than 400 of these. Of this…
Real-world data will likely play a bigger role in FDA drug reviews as the agency adopts lessons from Covid-19 to future regulatory decisions. The urgency of the pandemic has propelled U.S. health leaders to use data from sources such as patient medical records and mobile devices to help make decisions in real time. The Food…
National Institutes of Health Director Francis Collins was that rare Washington figure whose clout transcended presidential administrations and frequent power shifts in Congress — more so during a public health crisis. Now, the Biden administration needs to find a Collins clone. The search for a new leader for the world’s largest medical research agency, with…
Just 10 months since administration of the first COVID-19 vaccine dose, hundreds of millions of people worldwide have been inoculated. As of mid-August, more than 4 billion vaccine doses have been administered worldwide, and over 50% of eligible Americans are fully vaccinated. While there is much work to be done to ensure access across the globe, the pace of…
CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced the Lung Cancer Master Protocol (Lung-MAP) public-private partnership—which includes the National Cancer Institute (NCI), the National Clinical Trials Network (NCTN) Cooperative Groups (SWOG, ECOG-ACRIN, Alliance, and NRG), Friends of Cancer Research, and the Foundation for the National Institutes of Health (FNIH)—will study…
American cancer patients have collectively gained up to 14 million years of life since 1980 as a result of NCI-funded cancer trials conducted by the National Clinical Trials Network, a study led by SWOG Cancer Research Network found. The study, presented Sept. 20 at the annual meeting of the European Society for Medical Oncology, was…
