Johnson & Johnson (United States)

CASyM: Chemotype Annotation through Synthesis Mapping

Abstract The identification and annotation of chemotypes is central to structure–activity relationship studies and property optimization in drug discovery. Current computational approaches rely on predefined fragmentation rules or structural similarity to identify these molecular...

Variable Selection for the Propensity Score Model: Beyond Main Effects and Linear Relations

ABSTRACT Propensity score methods are frequently used to estimate treatment effects in observational studies. The propensity score is usually estimated using a logistic regression model with additive and linear effects. The limited literature on variable selection for the propens...

Selective γ8 transmembrane α‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolepropionic acid receptor regulatory protein negative allosteric modulators: Efficacy in preclinical antiseizure models

Abstract Objective RAP‐219, a potent selective negative allosteric modulator (NAM) of α‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolepropionic acid receptor (AMPAR) associated with γ8 transmembrane AMPAR regulatory protein (TARPγ8), is in phase 3 development for refractory focal epilepsy....

Acute Effects of Impella 5.5 on Biventricular Filling and Pressure–Volume Area in Patients With Heart Failure Associated Cardiogenic Shock

Use of Impella 5.5 in patients with decompensated heart failure-associated cardiogenic shock (ADHF-CS) is increasing as a bridge to advanced therapies. The effects of maximal trans-valvular unloading on biventricular filling and pressure–volume area (PVA) in ADHF-CS are poorly un...

Enhancing the translational potential of the ovine pulmonary adenocarcinoma model

Ovine pulmonary adenocarcinoma (OPA) is a transmissible lung cancer of sheep caused by Jaagsiekte sheep retrovirus (JSRV), resulting in substantial animal welfare concerns and economic losses worldwide. We previously developed a bronchoscopic JSRV catheter instillation technique...

MAIA frailty subgroup analysis: long-term follow-up with daratumumab plus lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma

Abstract In MAIA (Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma), daratumumab plus lenalidomide/dexamethasone (D-Rd) improved progression-free survival (PFS) and overall survival (OS) versus Rd in tran...

Associations between substance use by type and HIV viral suppression across multiple cohorts in the US

Substance use among people with HIV (PWH) represents an important obstacle to further reductions in HIV transmission. Using data from a diverse collection of five studies including people with HIV in care and those in community cohorts, we report results for analyses of the assoc...

Infections in MonumenTAL-1: a plain language summary of talquetamab treatment for relapsed/refractory multiple myeloma

Plain Language SummaryWhat is this summary about?This summary describes infection and immune cell data of participants receiving talquetamab for relapsed/refractory multiple myeloma (RRMM) in the MonumenTAL-1 study.What were the results?Almost 60% of participants receiving talque...

Assessing residual bias in real-world vaccine effectiveness studies: validating negative controls to avoid misleading results

Observational studies and randomized controlled trials demonstrate that vaccines protect against infections and severe outcomes, but real-world vaccine effectiveness estimates remain vulnerable to residual biases. Negative control outcomes can help detect and mitigate such biases...

Antibody Hotspot-Centric de Novo Design of Peptide Inhibitors of Influenza A Virus Membrane Fusion

Abstract Here we report the applicability of a hotspot-centric approach for de novo computational design of l-peptides based on crystal structures of antigen–antibody complexes. Broadly neutralizing antibodies (bnAbs) FI6v3 and CR9114, which target influenza A virus hemagglutinin...

Toward actionable biomarkers in psychiatry: a collaborative roadmap for precision clinical trials. An ACNP position paper

Abstract Psychiatric drug development remains constrained by diagnostic heterogeneity, insufficient and inconsistent drug response, high placebo response rates, and the absence of validated biomarkers that can reliably guide patient stratification, trial design, and regulatory de...

Impact of post‐chemotherapy classification on outcomes in stage III and IV unilateral favorable histology Wilms tumor: Pooled data from Children’s Oncology Group AREN0532, AREN0533, and AREN03B2 studies

Abstract Background Improvements in therapy for patients with favorable histology Wilms tumor (FHWT) have relied on refinement of risk stratification for therapeutic assignment through identification of favorable and unfavorable prognostic factors. Although well established in In...

The Changing Application of Vulnerability Across the Different Phases of Clinical Research

ABSTRACT The United States Food and Drug Omnibus Reform Act (FDORA) of 2022 established a legislative mandate requiring sponsors of pharmaceutical research to actively enhance the inclusion of historically underrepresented populations in clinical trials. This policy reflects the...

Understanding the Lived Experience of Fetal and Neonatal Alloimmune Thrombocytopenia: A Qualitative Study

Objective Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a rare alloimmune disease of pregnancy. This study aimed to better understand the disease burden of FNAIT and its impact on families through qualitative research. Study Design This exploratory, qualitative study...

Validation of electrochemiluminescent (ECL)-based immunoassay to determine the levels of antibodies against Escherichia coli O-lipopolysaccharide antigens

ABSTRACT Extra-intestinal pathogenic Escherichia coli (ExPEC) is a significant cause of invasive infections, including urinary tract infections, neonatal meningitis, and bacteremia. The emergence of multidrug-resistant ExPEC strains has intensified the need for effective prophyla...

Enhancing Evidence Generation by Linking Randomized Clinical Trials to Real‐World Data: The INVESTED‐Medicare Linkage Study

Real‐world evidence (RWE) derived from real‐world data (RWD) can complement randomized controlled trials (RCTs), yet the validity of RWD relative to RCT data remains insufficiently characterized. We obtained post hoc consent and linked individual participant data from the US‐base...

Secondary use and scholarly impact of a portfolio of clinical trials with shared individual participant level data: cross sectional study

Abstract Objective To assess the number, timing, characteristics, and scholarly impact of secondary publications generated using individual participant level data (IPD) from a portfolio of clinical trials shared with external investigators through a data sharing platform. Design...

Talquetamab for people living with relapsed/ refractory multiple myeloma: plain language summary of the MonumenTAL-1 study

Plain Language SummaryWhat is this summary about?This summary describes how well talquetamab worked and its safety at a median (midpoint) of 17–26 months follow-up from the MonumenTAL-1 study, which tested talquetamab treatment for a type of cancer called relapsed/refractory mult...

Milvexian with Antiplatelet Therapy after Acute Coronary Syndrome Event

BackgroundPatients are at increased risk for recurrent ischemic events after an acute coronary syndrome event. Milvexian, an oral factor XIa inhibitor, may reduce the risk of major adverse clinical events with minimal bleeding risk. MethodsIn this phase 3, randomized, placebo-con...

Nipocalimab for warm autoimmune hemolytic anemia: results from the phase 2/3 randomized, double-blind ENERGY study

Warm autoimmune hemolytic anemia (wAIHA) is a rare, life-threatening disease characterized by autoantibody-mediated destruction of red blood cells with no approved treatments. Nipocalimab, an immunoselective neonatal Fc receptor blocker, reduces circulating IgG levels, including...