News

With significant race and sex disparities in the area of peripheral artery disease, a study shows that clinical trials often lack representative patient populations.

UCB seeks approval of Bimzelx (bimekizumab-bkzx) for psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa.

A framework to understand the different approaches of trial matching solutions and the major operational and workflow challenges that all matching solutions share.

VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.

PL9643 ophthalmic solution is a melanocortin agonist with a novel mechanism of action that produced a clinically meaningful and statistically significant reduction in pain associated with dry eye disease.

The FDA has taken a clear position with Project Optimus in shifting toward more progressive tailored approaches while rejecting antiquated study designs to evolve clinical trial strategies to better align with newer drug classes.

Epkinly (epcoritamab-bysp), subcutaneously administered, T-cell engaging, IgG1-bispecific antibody, was previously granted Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory follicular lymphoma.

Gilead’s Biktarvy is now the first and only INSTI-based single-tablet regimen that is FDA approved and DHHS guideline recommended for people who are virologically suppressed with M184V/I resistance.

Survodutide produced a statistically significant improvement in metabolic dysfunction-associated steatohepatitis among 83% of those administered the drug compared to 18.2% of those given a placebo.

In an interview with ACT Editor Andy Studna, Gadi Saarony, CEO of Advarra talks about using technology to better diversify clinical trials and what to expect in the new year.

Phase Ia, open-label, escalating dose study to evaluate the safety and immunogenicity of therapeutic vaccine, TherVacB.

Trial data show Dupixent rapidly and significantly improved lung function compared to placebo in adults with uncontrolled chronic obstructive pulmonary disease with type 2 inflammation.

Agency reports concerns amid an increase in submitted data that has been fabricated, duplicated, or unreliable from third-party laboratories.

In an interview with ACT Editor Andy Studna, Gadi Saarony, CEO, Advarra, offers his thoughts on the status of the pharmaceutical industry improving diversity in clinical trials.

Enrollment and initial follow up has been completed for study set to test efficacy of cancer vaccine in individuals with Lynch syndrome.

An overview of patient perceptions of cancer clinical trials and the consent process among those who are currently enrolled in, or who recently completed, a cancer clinical trial.

Though artificial intelligence has yet to achieve its full potential, meaningful strides are still being made across the drug discovery funnel.

Clinical-stage biotech’s lead drug candidate, PrimeC for the treatment of ALS demonstrated a clinically meaningful effect on quality of life and on complication free-survival for patients.

Ocifisertib has shown significant single-agent activity in both solid and liquid tumors.

ARV-102 is a novel oral PROTAC protein degrader designed to cross the blood-brain barrier and target leucine-rich repeat kinase 2.

Upgrades include end-of-life equipment replacements and relocation.

The Phase I/II MajesTEC-1 trial (NCT03145181; NCT04557098) evaluated Tecvayli (teclistamab-cqyv) at a reduced dose of 1.5 mg/kg administered every two weeks in patients with relapsed/refractory multiple myeloma.

Phase II GenePHIT trial is evaluating the safety and efficacy of a single intracoronary infusion of AB-1002.

Data from the pivotal, global, randomized, double-blind, placebo-controlled, Phase III INDIGO trial show statistically significant and clinically meaningful progression-free survival for vorasidenib treating IDH-mutant gliomas.

Trial findings show Krazati (adagrasib) plus cetuximab was well tolerated with promising clinical activity among pretreated patients with locally advanced or metastatic colorectal cancer harboring a KRASG12C mutation

Datopotamab deruxtecan, the first TROP2-directed DXd antibody drug conjugate, is being evaluated for locally advanced or metastatic nonsquamous non-small cell lung cancer.

In an interview with ACT editor Andy Studna at SCOPE, Corrigan discusses what YPrime is doing to address challenges in clinical trials and results from the company's recently released eCOA report.

It is crucial throughout the clinical trials space to understand the challenges and triumphs of DEI.