AbbVie (United States)

An Exploratory Study of ABT-806, a Tumor-Specific Anti-EGFR Antibody, in Subjects with Recurrent or Metastatic Head and Neck and Other Squamous Cell Carcinomas

Introduction: Despite their benefit, current anti-EGFR therapies are limited by narrow efficacy profiles due to dose-limiting toxicities. This phase 2 open-label study evaluated the efficacy and safety of ABT-806, an EGFR-targeting antibody that is tumor specific, in patients wit...

Opioid use, disability, and patient‐reported cognitive impairment in migraine: Multi‐country results from the Chronic Migraine Epidemiology and Outcomes—International Study

OBJECTIVE: To characterize the population who do and do not use opioids to treat migraine in the Chronic Migraine Epidemiology and Outcomes-International (CaMEO-I) Study. BACKGROUND: Opioids are not recommended for migraine treatment because of efficacy and safety limitations. ME...

Histology resolved proteomic characterization of the triple negative breast cancer tumor immune microenvironment

Treatment options for the highly aggressive triple-negative breast cancer (TNBC) subtype remain limited, though the immune microenvironment represents a promising therapeutic target. We conducted a histology resolved tumor microenvironment analysis of TNBC by employing deep quant...

Efficacy and Safety of Risankizumab in Paediatric Patients With Psoriasis in the OptIMMize-1 Phase III Study.

BACKGROUND: Treatment options for paediatric patients with psoriasis are limited, and additional, more advanced therapies are needed. Risankizumab is an interleukin-23 inhibitor approved to treat moderate-to-severe psoriasis in adults. OBJECTIVES: To evaluate efficacy and safety...

Early improvements in function with atogepant as assessed by the Activity Impairment in Migraine–Diary: Post hoc analyses of three randomized, phase 3 clinical trials of atogepant for the preventive treatment of migraine

Abstract Objective Evaluate early functional improvements with the preventive migraine treatment atogepant using Activity Impairment in Migraine–Diary (AIM‐D) individual and activity limitation items, and complete improvement in AIM‐D Performance of Daily Activities (PDA) and Phy...

Considerations for understanding systematic reviews and network meta-analyses in neurological applications: a review and critique in chronic migraine

Network meta-analysis (NMA) is an evidence synthesis approach that combines direct and indirect evidence to estimate the relative effects of multiple treatments, including comparisons for which head-to-head clinical trial evidence is unavailable. Although methodological and repor...

DiploPhos: A Hemilabile Bisphosphine for Sterically Hindered Ni-Catalyzed Suzuki–Miyaura Couplings

Abstract Pharmaceutically relevant Suzuki–Miyaura cross-couplings (SMCs) often require designer phosphine ligands and palladium loadings above 1 mol % to couple Lewis basic, sterically congested substrates. Recent work has demonstrated that nickel is an attractive alternative to...

Development of items to assess noticeability and sun sensitivity among patients with non-segmental vitiligo

OBJECTIVES: Non-segmental vitiligo (NSV) is a chronic skin disease characterized by progressive, bilateral skin depigmentation that can impact health-related quality of life and psychosocial well-being. To assess emerging and new NSV treatments, patient-reported outcomes (PROs) t...

Progression GWAS followed by functional characterization implicates E3 ubiquitin ligase TRIM2 as a potential genetic modifier of Parkinson’s disease progression

ABSTRACT Parkinson’s Disease (PD) is a progressive neurodegenerative disorder, affecting 10 million people worldwide. While genome-wide association studies (GWAS) have identified many genetic variants associated with PD incidence, the genetics underlying PD progression are poorly...

Efficacy and safety of upadacitinib for Crohn’s disease in patients in East Asia: a post hoc analysis of randomized phase 3 studies

Abstract Background Upadacitinib is an oral Janus kinase inhibitor approved for the treatment of moderate-to-severe Crohn’s disease (CD). This post hoc analysis reports the efficacy and safety of upadacitinib for CD in patients in East Asia enrolled in the phase 3 clinical trials...

Predictive Safety in the Era of Artificial Intelligence: Promises, Limits, and the Case for an Enterprise Lifecycle Evidence Ecosystem

Drug safety remains central to patient benefit, as maximizing the value of beneficial therapies requires recognition, appropriate characterization, and effective mitigation of treatment-related adverse drug reactions (ADRs). These challenges, particularly with the advent of artif...

Local Pharmacokinetics and Tolerability of Topically‐Applied Bimatoprost to the Scalp of Male Patients With Androgenetic Alopecia

ABSTRACT Androgenetic alopecia (AGA) is one of the most common causes of hair loss in the male population, characterized by progressive baldness. This study was designed to evaluate the tolerability and local skin pharmacokinetics of bimatoprost in two different formulations in m...

Practical Scale-Up of Trickle Bed Continuous Hydrogenation for Pharmaceuticals

Abstract There is a growing trend in the pharmaceutical industry toward the adoption of continuous processing for the synthesis of active pharmaceutical ingredients (APIs) and intermediates. This enables access to novel synthetic routes by operating at high temperatures and high...

A new standard for lyophilizer characterization, comparability and efficient technology transfers

This paper details the implementation of the ΔT and ΔP methodologies—recently introduced in the literature—for monitoring of mass flow during sublimation, demonstrating their application across multiple pharmaceutical companies. As a relatively new approach, this work is assessin...

Self-normalization tests for change points in functional time series

Change point detection for functional time series has attracted considerable attention. Existing methods either rely on functional principal component analysis (FPCA), whose finite dimensional projection may perform poorly with complex data, or use bootstrap approaches whose test...

BAP: Bayesian Biomarker-Assisted Platform Design for Dose Ranging in Multi-Agent Multi-Dose Trials

Assessing the long-term benefits of new treatments can be expensive and time-consuming, particularly in disease areas with unmet medical needs. While platform trials enable the evaluation of multiple interventions simultaneously, they currently cannot assess studies involving mul...

Exposure–Response Analyses to Inform the Optimal Epcoritamab Monotherapy Dosing Regimen in Relapsed or Refractory Follicular Lymphoma

Epcoritamab is approved for treating various relapsed/refractory (R/R) lymphomas. In a phase I/II study in R/R follicular lymphoma (FL) patients, epcoritamab demonstrated high response rates (EPCORE NHL-1: objective response rate [ORR]: 82.0%, complete response [CR] rate: 62.5% [...