May 9th 2025
Updated GLISTEN trial results presented at EASL 2025 confirm that the IBAT inhibitor linerixibat significantly improved worst itch scores and itch-related sleep interference over 24 weeks in adults with primary biliary cholangitis.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Topline results from the Phase III DESTINY-Breast11 trial show that Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab, and pertuzumab significantly improves pathologic complete response rates compared to anthracycline-based standard-of-care regimens in the neoadjuvant treatment of high-risk, locally advanced HER2-positive early-stage breast cancer.
A Phase III randomized trial published in JAMA Network Open found no significant difference in symptom improvement between onabotulinumtoxinA injections and midurethral sling surgery in women with moderate to severe mixed urinary incontinence, with many ultimately needing both therapies to sustain relief.
New long-term extension data from the Phase IIb/III QUASAR trial demonstrate that Tremfya (guselkumab) maintains durable clinical and endoscopic remission through 92 weeks in adults with moderately to severely active ulcerative colitis, with consistent efficacy across prior biologic and JAK inhibitor exposure.
Semaglutide Significantly Improves Steatohepatitis, Fibrosis in Phase III MASH Trial
Interim results from the Phase III ESSENCE trial published in The New England Journal of Medicine show once-weekly semaglutide improved liver histology, metabolic markers, and weight loss in patients with biopsy-confirmed metabolic dysfunction–associated steatohepatitis and stage 2 or 3 fibrosis.
Phase III trial data published in The New England Journal of Medicine support Nucala’s role as an add-on biologic therapy to lower exacerbation rates and delay disease progression in patients with eosinophilic chronic obstructive pulmonary disease receiving standard inhaled treatment.
Phase III SELECT-GCA Trial Results Lead to FDA Approval of Rinvoq for Giant Cell Arteritis
Rinvoq (upadacitinib) becomes the first oral JAK inhibitor approved by the FDA for the treatment of giant cell arteritis in adults, following robust data from the Phase III SELECT-GCA trial demonstrating its efficacy in achieving sustained remission and reducing glucocorticoid exposure.
Ensuring Accuracy with Data in Oncology Research
April 30th 2025In this video interview, C.K. Wang, MD, chief medical officer, COTA, shares his key takeaways from a recent study he led on data reporting in oncology and highlights how stakeholders should be closely analyzing the accuracy of data they work with.