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Epkinly Demonstrates Encouraging Efficacy in Phase II Trial for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Promising Trial Data Leads to Breakthrough Designation for Eli Lilly’s Investigational KRAS G12C Inhibitor in Advanced, Metastatic Non-Small Cell Lung Cancer

Leqvio Shows Clinically Meaningful LDL-C Goal Attainment in Patients with Hypercholesterolemia in Phase IV Trial

Driving Transformation With a Connected Clinical Platform: 2025 Veeva R&D and Quality Summit Clinical Opening Keynote

Merck’s Oral PCSK9 Inhibitor Demonstrates Efficacy in Hypercholesterolemia

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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 ZENITH outcomes trial will enroll 11,000 patients worldwide to evaluate twice-yearly zilebesiran, aiming to improve long-term blood pressure control and reduce cardiovascular risk in uncontrolled hypertension.

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.