HHS Secretary Tom Price met Wednesday with patient advocacy groups to discuss options for reducing drug prices, participants in the meeting told BioCentury. Price told the patient advocates that the Trump administration is planning to act quickly on the president’s promises to slash prescription drug prices dramatically. “This is not going to be a…
The Senate health committee voted 14-9 Thursday to approve physician Scott Gottlieb to be the next commissioner of the Food and Drug Administration, sending the nomination to the full Senate. All 12 Republicans on the committee voted in favor of Gottlieb, a former venture capitalist who served as an FDA deputy commissioner during the…
My favorite stories are the ones that fork from the thing you initially set out to cover. I was already looking forward to interviewing Dr. Richard Pazdur, who heads the Food and Drug Administration’s new oncology center for excellence, and his colleague Julia Ann Beaver on this paper they published about eligibility criteria for…
Development of pediatric cancer drugs has long lagged behind adult drug development for two major reasons: The process is more difficult, and childhood cancer is rarer by far than adult cancer. These and other phenomena in pediatric oncology were the subject of a workshop held by the Friends of Cancer Research (Friends) and sponsored by…
Cancer clinical trial sponsors need to enroll a broader scope of subjects, including HIV patients and children, and the FDA is working on guidance to make that happen, the agency’s oncology chief told Bloomberg BNA. “We would like clinical trials to more accurately reflect the patient population that will actually be using the drug,…
Executive Summary Friends of Cancer Research seeks way of allowing high-quality efficacy data into label when supplemental NDA is not feasible. The US FDA may have to create a new system to incorporate post-marketing information into labeling for older off-patent drugs long used off-label. Jeff Allen, president and CEO of the Friends of Cancer…
Executive Summary US FDA drug reviewers argue that enrolling more heterogeneous patient populations could result in fewer postmarketing requirements and earlier satisfaction of pediatric study obligations. The US FDA’s push to expand oncology trial eligibility criteria includes highlighting the regulatory benefits for sponsors who pursue such strategies. Broadening eligibility criteria to include cohorts…
To address the shortfall of new oncology drugs developed for pediatric cancer patients, the Friends of Cancer Research (FOCR) convened a forum with invited speakers in Washington, D.C. Speakers discussed the feasibility of master trial platforms for early phase studies of multiple molecules concurrently across a range of pediatric cancer types, as well as prioritization…
President Donald Trump’s pick to lead the Food and Drug Administration, Scott Gottlieb, is a physician, a cancer survivor, a venture capitalist and a government insider who has long said he wants to tear down the wall of FDA regulations he believes is holding back innovation. “In so heavily prioritizing one of its obligations…
Breakthrough Therapy Designation is described on the FDA website as “a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).” It was signed into law in 2012,…
