R&D/Clinical Trials

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.

Results from the Phase II WILLOW trial show that enpatoran achieved a statistically significant dose-response and clinically meaningful reduction in disease activity in cutaneous and systemic lupus erythematosus with active rash.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, discusses the company's nationwide push to reduce cardiovascular risk through free LDL-C testing, public-private partnerships, and implementation science initiatives—all aimed at cutting CV events in half by 2030.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, explains why seamless communication and treatment continuity across primary care, cardiology, and rehabilitation are critical to improving outcomes and preventing care gaps for cardiovascular patients.