President Barack Obama Dec. 13 signed the 21st Century Cures Act, a bill that changes regulatory standards at FDA, slates additional research funds for NIH, and authorizes $1.8 million over seven years for Vice President Joe Biden’s National Cancer Moonshot Initiative. The legislation, a $6.3 billion health care reform measure designed to accelerate drug…
An industry attorney says FDA’s challenges with combination products suggest the creation of new disease-specific intercenter institutes, as called for by the 21st Century Cures law, could slow down reviews. FDA Commissioner Robert Califf recently indicated the agency is mulling how to reorganize around diseases. Language in the recently signed Cures bill requires FDA to…
Executive Summary Officials are enthusiastic about the possibility of ‘real world evidence’ supporting the regulatory process – but are also eager to tamp down expectations (or fears) that it will make a big difference any time soon. Real world evidence is definitely a “hot topic” at FDA. That phrase was used twice in one…
Executive Summary It is hard to find anything in the 21st Century Cures Act that justifies the hyperbole around its signing – or the criticism that it undermines patient safety. But, for the biopharma industry, the hype is important as a sign that pro-innovation messages have bipartisan appeal. One thing everyone in the…
Last night at the Andrew W. Mellon Auditorium, the Parker Foundation celebrated the passage of the 21st Century Cures Act with ACT for NIH, Friends of Cancer Research, and the Economic Innovation Group. Among the attendees were entrepreneur and philanthropist Sean Parker and his wife Alexandra Parker; Sen. Mark Warner; Rep. Fred Upton and his…
Executive Summary Topics on the table include the new 21st Century Cures law, PDUFA VI, the Trump Administration and more. Friends of Cancer Research CEO Jeff Allen sits down with Ramsey Baghdadi to discuss passage of the 21st Century Cures Act – signed into law by President Obama Dec. 13; implementation of the measure…
Ellen V. Sigal, PhD, Chair and Founder of Friends of Cancer Research (Friends) began the annual meeting with a conversation with Douglas R. Lowy, MD, National Cancer Institute (NCI) Acting Director, and Robert M. Califf, MD, U.S. Food and Drug Administration (FDA) Commissioner. “Cancer research is where it is today because of long-term funding…
As cancer care evolves into a field where genomic testing is used routinely to pinpoint diagnoses and determine treatments for specific subpopulations, a growing number of molecular tests are becoming available to oncologists. Invited speakers examined issues related to the role of these tests in precision medicine at a Senate briefing on Capitol Hill sponsored…
The Senate approved the 21st Century Cures Act, a wide-ranging bill that authorizes $1.8 billion over seven years for cancer research as well as $500 million over the next decade for FDA to streamline drug and device approval processes. The bill, which passed by a vote of 94-5 on Dec. 7, authorizes $4.976 billion…
A new era in research at George Washington University began with the official opening of the GW Cancer Center Wednesday evening. With a focus on patient care and collaboration, the GWCC will be a beacon of innovation, said President Steven Knapp. “If you’re looking for interdisciplinary work that’s really going to shape the future…
