News

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.

In the Phase III SELECT-GCA trial, Rinvoq (upadacitinib) 15 mg with a 26-week glucocorticoid taper significantly improved sustained remission rates and reduced disease flares in patients with giant-cell arteritis, offering a promising glucocorticoid-sparing treatment option with a favorable safety profile.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, highlights recent ICH guidelines and how risk should be an area of focus as trial designs continue to get more complex.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, talks AI and how change is needed for the clinical trials industry to fully understand its potential with automation.

Strategies for ensuring that innovation with PROs remains parallel with advancements in disease detection and progression.

Tolebrutinib did not show superiority over Aubagio (teriflunomide) in reducing relapse rates or MRI-detected inflammatory activity in relapsing multiple sclerosis, but early signals suggest it may have potential in slowing disability progression, warranting further long-term and comparative studies.

Full results from the Phase III ASCENT-04/KEYNOTE-D19 study demonstrated statistically significant and clinically meaningful survival benefits in patients with previously untreated, PD-L1-positive metastatic triple-negative breast cancer.

In the Phase III DESTINY-Breast09 trial, Enhertu (trastuzumab deruxtecan) and Perjeta (pertuzumab) significantly improved progression-free survival compared to the current standard of care in the first-line treatment of HER2-positive metastatic breast cancer, suggesting a potential new standard of care.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, discusses challenges the TMF space is currently facing and how it can utilize collaboration in making advancements.

The Phase II study, PROGRESS-AD, will evaluate the safety and efficacy of human monoclonal antibody AL101/GSK4527226 over 76 weeks.

In Phase III MINT trial, Uplizna (inebilizumab) demonstrated significant short-term efficacy and a manageable safety profile in adult patients with generalized myasthenia gravis, offering a promising B-cell–targeting treatment option pending long-term data.

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, discusses how artificial intelligence can aid in bringing therapies to rare disease patients faster.

In addition to meeting the primary endpoint of superior A1C reduction, the once-daily oral pill reduced weight by an average of 16 lbs.

Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.

In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.

With close collaboration between sponsors, CROs, and regulators, this emerging technology has the potential to greatly improve the lives of patients.