R&D/Clinical Trials

Pedro Valencia, VP, asset strategy leadership, oncology, outlines how unmet need, treatment stagnation, and pipeline innovation shape the company’s approach to solid tumor oncology following key data presented at ASCO 2025.

Results from the Phase III QWINT-1, QWINT-3, and QWINT-4 trials show that once-weekly insulin efsitora alfa achieved A1C reductions up to 1.31%, demonstrating non-inferiority to daily basal insulin in patients with type 2 diabetes.

Results from the Phase III REDEFINE 1 trial show that CagriSema led to a 22.7% mean weight reduction at 68 weeks in adults with overweight or obesity and a weight-related medical condition, but without diabetes.

Cancer patients’ journeys are complex and the benefit of a drug goes well beyond survival, even in cases of incurable and/or metastatic cancer.

Dive into a sampling of data drivers—and expanded insights—poised to impact and reshape our annual leaderboard.

The decision to advance prasinezumab to Phase III was based on results from the Phase IIb PADOVA trial, which demonstrated favorable trends towards slowed motor decline in patients with early-stage Parkinson disease.

A look at China's emergence as a hub for novel treatment pursuits—and ways international investors can best capitalize on the favorable research trajectory.

Special Guest Opinion: A reimagined regulatory framework for the life sciences is not just pro-investor—it is pro-patient.

Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.

Johnson & Johnson submitted a supplemental Biologics License Application to expand Stelara’s use to children aged two years and older with Crohn disease, supported by data from the Phase III UNITI-Jr trial.

Results from the Phase III TEMPLE trial show that patients administered Qulipta (atogepant) experienced significantly fewer treatment discontinuations due to adverse events compared to topiramate for preventative migraine treatment.

Results from the Phase II RedirecTT-1 trial showed a 78.9% overall response with the combination of Talvey plus Tecavli for heavily pretreated patients with relapsed/refractory multiple myeloma and true extramedullary disease.

Results from a first-in-human Phase Ia/Ib trial show that LY4170156 demonstrated a notably high overall response rate in women with heavily pre-treated, platinum-resistant ovarian cancer.

How next-generation ADCs are raising the bar in cancer treatment.

Early Phase I results for JNJ-79635322 demonstrated an 86.1% overall response rate in heavily pretreated multiple myeloma patients, including a 100% response in those naïve to B-cell maturation antigen and GPRC5D therapies.

Results from the Phase III CORALreef HeFH and CORALreef AddOn studies demonstrated tatistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol levels in patients treated with enlicitide decanoate for hyperlipidemia already on lipid-lowering therapies.

Results from the Phase II VLA1553-221 trial show that a full dose of Ixchiq demonstrated a 96.5% seroresponse rate in chikungunya-naïve children at day 180.

Results from the Phase II C-144-01 trial showed that a single infusion of Amtagvi demonstrated a 31.4% objective response rate in patients with advanced melanoma previously treated with anti-PD-1 and targeted therapies.

Results from the Phase III ASCENT-04/KEYNOTE-D19 trial demonstrated that Merck’s Keytruda combined with Gilead’s Trodelvy reduced the risk of disease progression or death by 35% in patients with PD-L1–positive inoperable or metastatic triple-negative breast cancer.

Results from the Phase III SERENA-6 trial show that camizestrant, in combination with a CDK4/6 inhibitor, significantly reduced the risk of disease progression or death in patients with HR-positive, HER2-negative advanced breast cancer and emergent ESR1 mutations.

Results from the Phase III VERITAC-2 trial demonstrated that vepdegestrant reduced the risk of disease progression or death by 43% in patients with ER+/HER2- advanced or metastatic breast cancer harboring ESR1 mutations.

Results from the Phase III AMPLITUDE trial of niraparib plus abiraterone acetate and prednisone demonstrated a statistically significant and clinically meaningful improvement in patients with metastatic castration-sensitive prostate cancer.

New data show that Uzedy significantly reduces relapse and healthcare utilization, while TEV-'749 has demonstrated strong efficacy with no post-injection delirium/sedation syndrome to date—advancing long-acting treatment options for schizophrenia.

Interim results from the Phase II COURAGE trial show that combining semaglutide with anti-GDF8 antibody trevogrumab preserves lean mass and enhances fat loss, offering a potential advancement in obesity treatment.

Poor investigator site selection remains a significant driver of spiraling costs and inefficiencies in clinical development.

The LRA CEO discusses his work with the organization and recent trends in Lupus R&D.

Across the board, oncologists are navigating a fast-changing landscape while managing full patient loads, reimbursement pressures, and evolving care standards.

With uncertainty surrounding the future of government funding, the onus is being placed on the private sector to continue driving new discoveries.

Clearance of ASC50 paves the way for a Phase I trial in patients with mild-to-moderate plaque psoriasis.

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.