News

Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.

In 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.

JNJ-1900 (NBTXR3), a novel, potentially first-in-class oncology therapy, demonstrated a median overall survival of 23 months from date of diagnosis as well as a favorable safety profile.

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.

Companies share their experience in future-proofing clinical data technology.

The single-inhaler demonstrated a meaningful improvement in lung function in the Phase III KALOS and LOGOS studies.

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.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, touches on how he would like to see greater industry collaboration in connecting cancer patients with RWD.

An article published by the Journal of the American Medical Association highlights recent updates made to the CONSORT checklist and how they ensure the accuracy of trial reports.

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.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, discusses how real-world data and real-world evidence have helped expedite cancer research.

Approval is based on results from the Phase III ASCEND trial, in which patients using the powder achieved freedom from pain by 2 hours post-treatment in 34.2% of migraine attacks.

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.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, highlights cost and treatment sequencing as some of oncology’s largest hurdles.

Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.

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.

In 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.

In the Phase Ib Beamion LUNG-1 clinical trial, zongertinib, an investigational irreversible tyrosine kinase inhibitor, demonstrated a median duration of response of 14.1 months.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, discusses a recent study he led on the validity of using real-world data for reporting mortality.

Early findings from Johnson & Johnson’s Phase IIb SunRISe-1 trial show the promise of TAR-200 in patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle-invasive bladder cancer, highlighting its potential as a non-surgical treatment alternative.

In the pivotal CREST clinical trial, sasanlimab in combination with Bacillus Calmette-Guérin met the primary endpoint of event-free survival.

How today’s SSO reduces site burden and spearheads clinical system interoperability.

Interim KEYNOTE-689 trial data show that perioperative Keytruda significantly lowers the risk of disease progression or recurrence in resectable, locally advanced head and neck squamous cell carcinoma, marking the first major clinical advance for this patient population in more than two decades.

Xofluza (baloxavir marboxil) met its primary endpoint in the CENTERSTONE trial, reducing the odds of untreated household members contracting influenza virus by 32%.

Lorundrostat, a selective aldosterone synthase inhibitor, significantly reduced systolic blood pressure in patients with uncontrolled and treatment-resistant hypertension in the Phase II Advance-HTN trial, indicating its potential as a safer, more effective alternative to current therapies.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, shares his key takeaways from Cencora’s recent TMF Leadership Summit and touches on the importance of oversight when working with outside stakeholders.

Brensocatib significantly reduced the rate of pulmonary exacerbations and slowed lung function decline in patients with non-cystic fibrosis bronchiectasis in the Phase III ASPEN trial.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, discusses how risk-based approaches must be prioritized amidst the increased demand for quality and compliance.

Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics demonstrated a 2.0-point reduction in PANSS total score in the ARISE study, failing to meet statistical significance.