Explore the latest in drug development, including evolving methodologic, economic, and regulatory challenges to new drug innovation.
This randomized clinical trial investigates the efficacy, safety, and tolerability of danuglipron treatment for 16 weeks in adults with type 2 diabetes and inadequate glycemic control on diet and exercise, with or without the use of metformin.
This cross-sectional study examines and compares the time taken from the accelerated approval of cancer and noncancer drugs to the initiation of confirmatory studies in the US.
This Viewpoint discusses a current Supreme Court lawsuit, Amgen v Sanofi, involving Amgen’s broad patents on PCSK9 that could effectively prevent other manufacturers from producing similar or even clinically superior antibodies, with important negative consequences for patients.
This proof-of-concept study examines whether a data-driven, quantitative approach can work to help identify and prioritize opportunities in biomedical product innovation for medical disorders with high public health burden and high health care costs.
This randomized clinical trial evaluates the efficacy and safety of the FINLAY-FR-2 and FINLAY-FR-1A COVID-19 vaccines in the Iranian population.
This systematic review with meta-analysis examines the regulatory oversight of the accelerated approval pathway and evidence generation for idelalisib during premarketing, postmarketing, and premarketing withdrawal periods.
This cross-sectional study examines National Institutes of Health and pharmaceutical industry investments in recent drug approvals.
These 2 phase 2 randomized clinical trials evaluated the safety and efficacy of single-dose combination tixagevimab and cilgavimab administered intramuscularly and intravenously, each compared with placebo, for treatment of symptomatic nonhospitalized adults with early COVID-19.
This randomized clinical trial describes the data supporting safety, immunogenicity, and efficacy of the NVX-CoV2373 vaccine for COVID-19 in adolescents aged 12 through 17 years in the PREVENT-19 trial.
This Viewpoint discusses the importance of the patient voice in regards to eye research and funding.
This bayesian analysis of a clinical trial examines the effectiveness of bayesian design for adaptively assigning patients to effective dosage regimes.
This cross-sectional study determines the frequency of and rationale for US Food and Drug Administration (FDA) approval of drugs not meeting pivotal trial primary efficacy end points.
This case-control study compares levels of serotonin type 4 receptor as well as verbal memory, working memory, reaction time, emotion recognition bias, and negative social emotions in unmedicated patients with major depressive disorder vs individuals without this diagnosis.
This cross-sectional study evaluates patient exposure to oncology drugs withdrawn from the US Food and Drug Administration (FDA) Accelerated Approval program.
This cross-sectional study evaluates regulatory decisions and health technology assessments in Australia, Canada, and the UK regarding new drugs approved by the US Food and Drug Administration in 2017 through 2020, as well as estimates the US cost per patient per year for drugs receiving negative recommendations.
This cross-sectional study systematically characterizes the frequency of delayed confirmatory trials relative to deadlines set by the US Food and Drug Administration.
This study examines the Food and Drug Administration’s accelerated approval pathway and whether preapproval initiation was associated with faster conversion to traditional approval or withdrawal for drugs with nononcology indications.
This qualitative study explores academic oncologists’ needs and satisfaction with expanded patient access to investigational drugs.
This Viewpoint discusses 3 bills introduced recently in Congress that focus on patent eligibility, fraud, and quality and that have major implications for clinical medicine and pharmaceutical development.
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