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Category: In the News

Clinical Leader — FDA Finalizes Guidance On Dose Optimization For Oncology Therapies

A survey of over 1,000 patients with metastatic breast cancer found that 86.1% reported having experienced at least one significant treatment-related side effect, with 20.3% of those patients ending up in the hospital or emergency room and 43.2% missing at least one treatment.1 Subsequent dose reductions resulted in relief for 82.6% of patients.1 This study highlights the…

The Cancer Letter — Friends of Cancer Research announces publication focused on enhancing clinical trials with pragmatic trial elements

Friends of Cancer Research announced the publication of a commentary on the significance of pragmatic clinical trials in ESMO Real World Data and Digital Oncology. PCTs evaluate the effectiveness of interventions in settings that more closely resemble real-world care, aiming to produce evidence directly applicable to clinical practice. Recognizing the value that PCTs bring to oncology…

Regulatory Focus — Researchers tout the benefits of pragmatic clinical trials

Pragmatic clinical trials (PCTs) offer a promising alternative to explanatory trials, according to a recent commentary published in the ESMO Real World Data and Digital Oncology. Such trials feature simplified study protocols and data collection methods and enable a wider patient selection pool, which the authors believe can enhance clinical research. Clinical trials with pragmatic elements can…

Pink Sheet — FDA Disruption: If Trump Wins, Could Big Changes Be Coming?

Underground tunnels. That is where the conversation began between Twitter/X CEO Elon Musk and former President Donald Trump before moving to reforming the US Food and Drug Administration. Musk was discussing the impact of overregulation on drilling underground tunnels to alleviate traffic in congested cities when he deftly turned to another area that he believes…

American Association for Cancer Research — AACR CEO Margaret Foti to Receive Prestigious Beacon Award for Women Leaders in Oncology

Margaret Foti, PhD, MD (hc), chief executive officer of the American Association for Cancer Research (AACR), has been selected as the recipient of the 2024 Beacon Award for Women Leaders in Oncology in recognition of her tireless and innovative leadership in the fight against cancer. The Beacon Award for Women Leaders in Oncology was established…

STAT — Jeff Shuren stabilized the FDA’s medical devices center, winning over industry but not all patients

Retirements from the Food and Drug Administration are hardly shocking, especially in the wake of pandemic burnout. But when longtime medical device director Jeff Shuren announced his departure in July, the device world was stunned. Industry leaders, patient advocates, and FDA colleagues alike had grown accustomed to the ambitious, politically-savvy regulator. “It’s sort of hard to imagine…

Korea Biomedical Review — Lunit nearing commercialization deal with multinational pharma for AI biomarker platform

Lunit, a Korean medical AI imaging company, is reportedly close to securing a major commercialization contract with a multinational pharmaceutical company for its AI biomarker platform, Lunit SCOPE. The company confirmed that these negotiations are expected to be finalized by the end of the year. According to Lunit, Lunit SCOPE’s biomarker analysis services are currently being…

The Cancer Letter — Kamala Harris widely expected to continue Cancer Moonshot; Conservatives present their vision in Project 2025

What will happen to biomedical research and health care in the aftermath of the 2024 election? The differences in outcomes couldn’t be more stark.   Vice President Kamala Harris, who became the Democratic frontrunner on July 21 after President Joe Biden announced his decision not to seek reelection, is expected to pursue a science agenda…

The Cancer Letter — Monica Bertagnolli and Brett Guthrie named Friends 2024 Cancer Leadership Award recipients

NIH Director Monica Bertagnolli and Rep. for Kentucky’s 2nd congressional district, Brett Guthrie were named recipients of Friends of Cancer Research 2024 Cancer Leadership Award. Bertagnolli and Guthrie will be honored on Sept. 19, 2024, in Washington, DC. Monica Bertagnolli will receive the Ellen V. Sigal Advocacy Leadership Award, recognizing her incredible contributions to the…

The Cancer Letter — Monica Bertagnolli and Brett Guthrie named Friends 2024 Cancer Leadership Award recipients

NIH Director Monica Bertagnolli and Rep. for Kentucky’s 2nd congressional district, Brett Guthrie were named recipients of Friends of Cancer Research 2024 Cancer Leadership Award. Bertagnolli and Guthrie will be honored on Sept. 19, 2024, in Washington, DC. Monica Bertagnolli will receive the Ellen V. Sigal Advocacy Leadership Award, recognizing her incredible contributions to the…