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February 23, 2021
May 11, 2023
WASHINGTON — The Food and Drug Administration needs to hire scores of in-demand scientists, and that difficult task could become even harder if the agency gives in to pressure from either Republicans or the Biden administration to return federal workers to the office. There are more than 2,000 vacancies at the FDA right now —…
Learn MoreMay 11, 2023
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…
Learn MoreMay 11, 2023
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…
Learn MoreMay 11, 2023
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,…
Learn MoreMay 9, 2023
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…
Learn MoreMay 5, 2023
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…
Learn MoreMay 3, 2023
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…
Learn MoreApril 27, 2023
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…
Learn MoreApril 24, 2023
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…
Learn MoreApril 24, 2023
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…
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