INNOVATION OVERSIGHT — House Republicans want greater oversight of CMS’ Center for Medicare and Medicaid Innovation, Robert reports. Several GOP lawmakers took aim at CMMI for its plan to slash Medicare payments to drugs cleared under the Food and Drug Administration’s accelerated approval program. At a House Ways and Means Health Subcommittee hearing on Wednesday, Republicans said…
Ford’s Theatre Society will celebrate the legacy of President Abraham Lincoln at its annual gala performance on Sunday, June 11, 2023, at Ford’s Theatre. For more than 45 years, Ford’s Theatre Society has hosted this bipartisan event, which provides crucial support to the nonprofit’s theatrical and educational programs. As part of the evening, Ford’s will…
Two studies presented at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women’s Cancer underscore the importance of enrolling patients with gynecologic cancer on clinical trials and of assuring trial access to racial minorities. One study found a statistically significant improvement in overall survival for patients with platinum-resistant ovarian cancer enrolled on clinical trials,…
Drug development of the modern era is night and day different than what it was 2 decades ago. The scope of oncologic drugs has narrowed as more targetable markers come into focus, and trials face participant recruitment and diversity issues. Additionally, the rise of digital health technology, coupled with increased patient access to information, has…
This is but one of a multitude of questions being considered by FDA and a group of biopharmaceutical companies as they design a framework to streamline regulation of gene and cell therapies. The effort is led by Friends of Cancer Research. As more sponsors invest in novel immunotherapies for cancer, regulatory science experts are exploring…
President Biden’s presumed pick to lead the National Institutes of Health, Monica Bertagnolli, will face a slew of questions on the multibillion-dollar agency’s spending and oversight in her upcoming confirmation battle. This week, though, she won’t face what otherwise would have been Congress’s first round. A source close to the top cancer official, who announced…
Monica Bertagnolli never had the luxury of easing into her new job as head of the U.S. National Cancer Institute (NCI). Several weeks after taking over the largest component of the National Institutes of Health (NIH) in October 2022, the then–63-year-old surgical oncologist was diagnosed with early-stage breast cancer and underwent surgery followed by chemotherapy…
US Food & Drug Administration officials routinely emphasize one key point in framing the questions they pose to their expert advisory committees: the agency values the discussion of the issues by the invited experts much more than the final count on any vote they may take. Commissioner Robert Califf has urged that the agency apply…
Individuals living with HIV historically have been at higher risk for non-Hodgkin lymphoma. They also are considerably more likely to die of the disease than individuals without HIV, according to an NCI-led study (adjusted HR = 7.23; 95% CI, 1.7-2.3). The proliferation of antiretroviral therapies and more effective cancer treatments has reduced the proportion of…
Multiple sources have confirmed that President Joe Biden intends to nominate Bertagnolli to the post of NIH director. Bertagnolli has served as head of NCI for not-quite seven months (The Cancer Letter, Oct. 7, 2022). At AACR, Bertagnolli was rolling out her National Cancer Plan, which updates the thinking behind the cancer program (The Cancer Letter, April…
