News

In the Phase III VISIONARY study, sibeprenlimab, an investigational monoclonal antibody, showed a 51.2% reduction in proteinuria at nine months of treatment.

New data from the IRAKLIA and IZALCO trials, presented at the 2025 ASCO Annual Meeting, demonstrate that subcutaneous Sarclisa delivered via an on-body delivery system offers non-inferior efficacy to IV infusion in patients with relapsed or refractory multiple myeloma, while significantly reducing infusion-related reactions and improving patient satisfaction.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), talks multisite clinical research corporations and how they can streamline clinical operations.

Results from the Phase Ib/II CARTITUDE-1 trial demonstrated that a single infusion of Carvykti delivered durable, treatment-free remissions for at least five years in a third of patients with relapsed or refractory multiple myeloma.

Case study highlights how clinical operations teams can overcome complex regulatory and operational hurdles to finish a trial on time and on budget.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), highlights opportunities to improve upon inefficiencies that currently exist in clinical workflows.

Despite positive results from a Phase I/II trial of its investigational pandemic influenza vaccine, mRNA-1018, Moderna’s award for almost $600 million to accelerate vaccine development will be terminated.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses the administration’s policy and how it could force pharma companies to reduce funding for clinical R&D.

Interim results from the global MATTERHORN study mark the first time an immunotherapy has demonstrated statistically significant event-free survival in a Phase III trial for resectable gastric and gastroesophageal junction cancers, signaling a potential shift in standard perioperative care.

In the Phase III IMforte trial, Tecentriq (atezolizumab) and Zepzelca (lurbinectedin) reduced the risk of disease progression or death by 46% as a first-line maintenance therapy for patients with extensive-stage small cell lung cancer.

Phase III data presented at ASCO 2025 and published in The New England Journal of Medicine show that Pfizer’s Braftovi (encorafenib), combined with Erbitux (cetuximab) and mFOLFOX6, significantly improves overall survival and progression-free survival in treatment-naïve patients with BRAF V600E-mutant metastatic colorectal cancer—potentially establishing a new first-line standard-of-care for this high-risk population.

In this video interview, Ron Lanton, partner, Lanton Law, highlights how tariffs on active pharmaceutical ingredients could affect resources for maintaining and accelerating R&D pipelines.

In the DESTINY-Breast09 study, Enhertu (fam-trastuzumab deruxtecan-nxki) plus pertuzumab reduced the risk of disease progression or death by 44% in patients with HER2-positive metastatic breast cancer.

In this video interview, Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines.

As biotech innovation accelerates, the clinical research workforce is rapidly eroding—threatening the future of drug development. From workforce burnout to training program cuts and talent pipeline collapse, clinical trial professionals must confront this escalating crisis head-on to sustain progress and protect public health.

In this video interview, Ron Lanton, partner, Lanton Law, discusses how a potential increase in drug costs could affect the clinical research industry.

MK-1084, Merck’s investigational KRAS G12C inhibitor, showed a manageable safety profile along with antitumor activity in the Phase I KANDLELIT-001 study.

A blend of FSO and FSP models in the landscape of artificial intelligence can ensure CROs stay up to date with the unique demands of industry.

For the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer, patritumab deruxtecan did not meet statistical significance for overall survival in the HERTHENA-Lung02 trial.

Pimicotinib, an investigational colony stimulating factor-1 receptor inhibitor being developed by Abbisko Therapeutics and licensed by Merck KGaA, met MANEUVER’s primary endpoint of objective response rate.

In patients with first-line metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitors, Trodelvy (sacituzumab govitecan-hziy) achieved a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy.

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.

In a post-hoc analysis from the Phase III ARANOTE trial, new results show metastatic castration-sensitive prostate cancer patients treated with Nubeqa plus ADT experienced a clinically meaningful improvement in health-related quality of life and delayed pain progression.

In this video interview, Michel van Harten, MD, CEO, myTomorrows, highlights the potential of artificial intelligence in digital twin technology.

How digital intake solutions driven by technological advancements can help overcome the challenges of operating across different regulatory markets.

Five- and eight-year trial data to be presented at ASCO demonstrate durable survival outcomes with Xtandi (enzalutamide) plus ADT, reinforcing its role as a frontline standard in metastatic hormone-sensitive prostate cancer.

In this video interview, Michel van Harten, MD, CEO, myTomorrows, discusses how patient education and remote monitoring can help with reducing the burden of trial participation.

One-year results from the Pavilion study showed patients who received Susvimo (ranibizumab) refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale.

In this video interview, Michel van Harten, MD, CEO, myTomorrows, highlights how artificial intelligence can be used to address logistical barriers such as access and treatment cost.

Data from the FIBRONEER-IPF and FIBRONEER-ILD studies, published in The New England Journal of Medicine, highlight nerandomilast’s potential as a first-in-class PDE4B inhibitor for idiopathic and progressive pulmonary fibrosis, demonstrating efficacy as monotherapy or with existing antifibrotics.