News

In this Q&A from the 2025 Veeva R&D and Quality Summit, Ibrahim Kamstrup-Akkaoui, vice president of data systems innovation at Novo Nordisk, discusses simplifying system use through the company’s DataNow program and taking a measured, stepwise approach to applying AI and automation across the clinical development lifecycle.

In this video interview, Adrianne Rivard, senior community development manager at myTomorrows, explains how AI can reduce the time physicians spend pre-screening patients for clinical trial eligibility.

Results from the Phase II EPCORE NHL-6 trial (NCT05451810) showed that Epkinly demonstrated an overall response rate of 64.3% in patients with relapsed or refractory diffuse large B-cell lymphoma.

Designation supports the potential of olomorasib plus Keytruda to address unmet needs in the first-line treatment of patients with KRAS G12C-mutant non-small lung cancer with high PD-L1 expression.

Results from the Phase IV V-DIFFERENCE trial (NCT05192941) found that 85% of patients on Leqvio reached guideline-recommended LDL-C targets versus 31% on placebo at 90 days.

In the clinical opening keynote of Veeva’s R&D and Quality Summit, Jim Reilly of Veeva and Jennifer Sheller of Merck outlined how connected clinical platforms can cut costs, reduce inefficiencies, and improve site and patient experiences, with Merck’s “Zero Gravity” program demonstrating early operational gains.

Results from the Phase III CORALreef Lipids trial (CT05952856) showed that patients treated with enlicitide decanoate for hypercholesterolemia demonstrated statistically significant and clinically meaningful reductions in LDL cholesterol.

Results from the Phase III BaxHTN trial (NCT06034743) showed baxdrostat achieved statistically significant and clinically meaningful reductions in systolic blood pressure in patients with hard-to-control hypertension.

In this video interview, Sunny Kumar, MD, partner at Informed Ventures, explains how startups often underestimate the need for scalable platforms that fit into pharma workflows, limiting adoption of otherwise promising point solutions.

The Phase III VICTOR trial (NCT05093933) evaluated Verquvo in patients with stable, well-treated chronic heart failure and reduced ejection fraction without a recent worsening heart failure event.

In this video interview, Sunny Kumar, MD, partner at Informed Ventures, discusses how FDA guidance and investor expectations are shaping resilient trial designs that use adaptive methods, virtual controls, and decentralization to lower costs and accelerate patient access.

In this video interview, Sunny Kumar, MD, partner at Informed Ventures, explains how organizational complexity, regulatory caution, and cultural risk aversion slow innovation in clinical trials, while tools like generative AI may help reduce operational barriers.

How decentralized clinical trial designs and smart data integration are transforming the patient experience.

An overview of key considerations shaping the BGM and CGM decision, why both often coexist in trials today, and how eCOA platforms play a critical role in supporting this data collection at scale.

In this video interview, Sunny Kumar, MD, partner at Informed Ventures, discusses how clinical operations leaders can close technology gaps in decentralized trials by provisioning devices and designing simple, intuitive tools to ensure equitable patient access.

FDA approves COVID-19 vaccines from Moderna, Pfizer-BioNTech, and Novavax targeting the LP.8.1 sublineage of SARS-CoV-2, with eligibility limited to adults aged 65 years and older and those with underlying medical conditions that place them with a high risk for severe disease.

The Phase III NIMBLE trial met its primary and key secondary endpoints, with cemdisiran monotherapy showing robust efficacy in generalized myasthenia gravis and the cemdi-poze combination achieving near-complete complement inhibition. Regeneron plans a 2026 US regulatory submission.

A new systems-based framework helps sponsors and CROs move beyond prediction to understand why site selection succeeds or fails, enabling targeted interventions that boost recruitment, data quality, and trial efficiency.

The Phase II RAINBOWFISH study found that infants treated with Evrysdi (risdiplam) within six weeks of birth reached major motor milestones over two years.

In this video interview, Sunny Kumar, MD, partner at Informed Ventures, explains how high upfront costs and limited proof of cost savings are slowing large-scale adoption of decentralized clinical trial models.

Breakthrough Therapy Designation was based on results from the Phase I/II RAINFOL-01 trial, which showed encouraging clinical activity in patients treated with Rina-S (rinatabart sesutecan) for advanced endometrial cancer.

Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), and Kyle McAllister, co-founder, CEO, Trially, discuss how research sites are navigating political funding pressures, adapting to NIH budget constraints, and leveraging new cost-containment strategies to sustain clinical research.

Strategic AI applications are helping life sciences teams overcome hidden bias, accelerate data discovery, and improve evidence integrity at the start of the pipeline.

The FDA will now publish adverse event data from FAERS on a daily basis, marking a major step toward greater transparency in drug development.

Ampreloxetine is being developed to address the root cause of blood pressure instability in multiple system atrophy, aiming to improve patient outcomes and independence.

In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed stories of the week—covering the Supreme Court’s decision to uphold NIH funding cuts tied to DEI, Phase II data showing oral VK2735 achieved over 12% weight loss, and Phase III results where Padcev plus Keytruda improved survival in muscle-invasive bladder cancer.

This explainer unpacks how recent US policy shifts are reshaping diversity, equity, and inclusion in clinical research, exploring the ripple effects on patients, sites, sponsors, and investigators.

Results from the first part of a Phase I/II trial (NCT06569823) showed that Z-1018 generated immune responses comparable to Shingrix, with a 100% antibody response rate and nearly 90% CD4⁺ T-cell response in patients with shingles.