News

For the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer, patritumab deruxtecan did not meet statistical significance for overall survival in the HERTHENA-Lung02 trial.

Pimicotinib, an investigational colony stimulating factor-1 receptor inhibitor being developed by Abbisko Therapeutics and licensed by Merck KGaA, met MANEUVER’s primary endpoint of objective response rate.

In patients with first-line metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitors, Trodelvy (sacituzumab govitecan-hziy) achieved a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy.

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.

In a post-hoc analysis from the Phase III ARANOTE trial, new results show metastatic castration-sensitive prostate cancer patients treated with Nubeqa plus ADT experienced a clinically meaningful improvement in health-related quality of life and delayed pain progression.

In this video interview, Michel van Harten, MD, CEO, myTomorrows, highlights the potential of artificial intelligence in digital twin technology.

How digital intake solutions driven by technological advancements can help overcome the challenges of operating across different regulatory markets.

Five- and eight-year trial data to be presented at ASCO demonstrate durable survival outcomes with Xtandi (enzalutamide) plus ADT, reinforcing its role as a frontline standard in metastatic hormone-sensitive prostate cancer.

In this video interview, Michel van Harten, MD, CEO, myTomorrows, discusses how patient education and remote monitoring can help with reducing the burden of trial participation.

In this video interview, Michel van Harten, MD, CEO, myTomorrows, highlights how artificial intelligence can be used to address logistical barriers such as access and treatment cost.

Data from the FIBRONEER-IPF and FIBRONEER-ILD studies, published in The New England Journal of Medicine, highlight nerandomilast’s potential as a first-in-class PDE4B inhibitor for idiopathic and progressive pulmonary fibrosis, demonstrating efficacy as monotherapy or with existing antifibrotics.

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.

The FDA’s Oncologic Drugs Advisory Committee voted against an application for Columvi (glofitamab) plus GemOx for relapsed/refractory diffuse large B-cell lymphoma due to concerns about the applicability of multiregional trial data to the US patient population.

In this video interview, Michel van Harten, MD, CEO, myTomorrows, discusses where the clinical research industry currently stands with AI adoption.

A pragmatic approach to streamlining technology and innovating processes will help advance clinical data management.

Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.

In this video interview, Michael Liu, discusses the need for continued monitoring of these medical research cuts to gain a better understanding of exactly what trials they are impacting.

Improving access while maintaining a high level of research.

The global, randomized IDeate-Esophageal01 study will evaluate ifinatamab deruxtecan, a B7-H3–targeted antibody-drug conjugate, versus physician’s choice of chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma following progression on platinum-based chemotherapy and immune checkpoint inhibitors.

In this video interview, Michael Liu, medical student and researcher at Harvard Medical School, discusses how these cuts are impacting critical areas of clinical research such as staffing and patient access.

Welireg (belzutifan), an oral HIF-2α inhibitor, demonstrated an objective response rate of 26% in the LITESPARK-015 study.

In this video interview, Michael Liu, medical student and researcher at Harvard Medical School, highlights key findings from a recent breakdown of funding cuts and how they are impacting research institutions.

In the Phase II LUMINOSITY study, Emrelis (telisotuzumab vedotin-tllv), a first-in-class c-Met-directed antibody-drug conjugate, demonstrated an overall response rate of 35%.

In this video interview, Michael Liu, medical student and researcher at Harvard Medical School, discusses a recent study he conducted on the characterization of research funding cuts.

Merck’s Phase III KEYNOTE-B96 trial shows significant overall and progression-free survival gains with Keytruda plus chemotherapy in patients with PD-L1–positive, platinum-resistant recurrent ovarian cancer, marking a breakthrough for immune checkpoint inhibitors in this hard-to-treat population.

Industry leaders share their thoughts on the NIH funding cuts and how they are impacting clinical research.

Decision follows underwhelming Phase II results from GALAXIES Lung-201 and H&N-202 trials, prompting iTeos and GSK to end development of the TIGIT-targeting antibody and halt enrollment in all ongoing belrestotug studies.

Tufts CSDD is conducting new research on trends in study monitoring and data collection.