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Expanded relationship will utilize Medidata’s artificial intelligence solutions.

The potential of PBPK modeling in answering key questions around these drugs.

In the Complete Response Letter to Dynavax, the FDA stated that the supplemental Biologic License Application based on findings from the Phase I HBV-24 trial lacked sufficient data to support a full evaluation of the efficacy or safety of a four-dose Heplisav-B regimen in adults on hemodialysis.

A forum of prominent industry stakeholders highlights the challenges for patients in navigating the multiple legal, regulatory, and ethical barriers to cross-border participation.

In part 3 of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints discuss what could be holding stakeholders back from adopting risk-based quality management.

Blockbuster cancer therapies failed to improve progression-free survival as combination.

Trial data met the pre-specified futility criteria for the primary endpoint of recurrence-free survival with the combination of vibostolimab and Keytruda (pembrolizumab) in the adjuvant treatment of patients with resected high-risk melanoma.

In part 2 of this video interview series, Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints highlight what stood out to them from the results of a recent study on RBQM adoption.

The Tufts Center for the Study of Drug Development is gathering new benchmark data on the vendor qualification process including the time, cost, and resources required to qualify contract service and technology vendors.

In part 1 of this video interview series with Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine and Steve Young, chief science officer, CluePoints, Getz touches on the findings from a recent study on RBQM adoption.

A survey conducted at this year’s Pistoia Alliance conference determined that although 70% of life sciences experts acknowledge artificial intelligence’s potential, many still struggle with its initiation and implementation.

A cohort study used county-level data on social determinants of health to examine their association with oncology study access.

Findings from the Phase III KEYNOTE-B21 trial show that Keytruda (pembrolizumab) plus chemotherapy as adjuvant therapy, with or without radiotherapy, administered to patients with newly diagnosed high-risk endometrial cancer following surgery with curative intent did not achieve superiority in disease-free survival over placebo.

Midpoint clinical trial data for Teal Health’s Teal Wand is promising after exceeding initial enrollment numbers in the last 6 months.

Multicentric studies on diarrhea are essential for comprehending its epidemiology, causes, and treatment outcomes.

Cell-selective, adeno-associated virus gene therapy DB-OTO restored hearing to normal levels within 24 weeks in a child born with profound genetic deafness due to variants of the otoferlin gene.

Phase Ia trial of VYN202, expected to begin this quarter, will enroll approximately 64 healthy participants.

Phase I/IIa HORNBILL trial results show Boehringer Ingelheim’s novel humanized monoclonal anti-Sema3A antibody was well tolerated and showed early signs of efficacy.

For antibody drug conjugates to reach their full potential, developers should focus on addressing current challenges such as safety and efficacy.

Systematic review of over 300 randomized clinical trials sought to determine how often these values were overestimated in contemporary cardiovascular trials.

Johnson & Johnson’s novel targeted therapy TAR-200 produced a greater than 80% complete response rate in patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle-invasive bladder cancer with carcinoma in situ.

In the fourth and final part of this video interview with ACT editor Andy Studna, Rohit Nambisan, CEO & founder of Lokavant looks into the future of feasibility studies, the integration of AI, and how they are driving more personalized approaches.

How innovative trial designs and advanced imaging modalities can address the challenges of early drug development to optimize outcomes for patients with solid tumors.

In part 3 of this video interview with ACT editor Andy Studna, Rohit Nambisan, CEO & founder of Lokavant analyzes some of the most common mistakes he has seen stakeholders make in feasibility studies and how they can be addressed.

Partnership expected to utilize Walgreens’ pharmacies as recruitment and trial sites for a clinical study regarding obesity, weight issues, and type 2 diabetes, mainly in historically underrepresented groups.

The combination of Calquence (acalabrutinib; AstraZeneca) plus bendamustine and rituximab generated a clinically meaningful improvement in progression-free survival in the first-line treatment of adults with mantle cell lymphoma.

In part 2 of this video interview with ACT editor Andy Studna, Rohit Nambisan, CEO & founder of Lokavant touches on structuring feasibility studies and how they can make running a trial more efficient.

Survey study assessed 58 cancer centers in the United States to identify their greatest challenges.