News

Device designed to address tricuspid regurgitation through a vein in the leg.

There were no safety or efficacy issues identified in the FDA's complete response letter for Lymphir, with no additional trials required.

In clinical trials, patients administered Aurlumyn monotherapy experienced a significantly reduced risk of the need for amputation associated with severe frostbite.

Trials of Augtyro are ongoing for this tumor-agnostic indication, which could provide a durable treatment option for patients with NTRK-positive disease.

In an interview with ACT editor Andy Studna at SCOPE, Deyle, VP & GM, Clinical Research, Flatiron Health discusses real-world evidence in clinical trials.

The Onivyde combination was evaluated in the open-label, multicenter, randomized Phase III NAPOLI 3 trial, showing significantly improved overall survival in patients with metastatic pancreatic adenocarcinoma.

The drug development process, beginning with preclinical research up to when the product goes to market, requires time, risk, and high costs.

In an interview with ACT editor Andy Studna at SCOPE, Young, Chief Science Officer, CluePoints discusses where the industry is currently adopting RBQM and the level of comfort that comes with it.

In an interview with ACT editor Andy Studna at SCOPE, Everhart, MD, FACP, clinical vice president, internal medicine, Signant Health discusses decentralized trials and how they may be increasing site burden.

Breakout session at SCOPE Summit 2024 discusses the potential use of artificial intelligence to improve clinical trial strategy generation.

Adjusting to the changing dynamics of the clinical research associate role.

Phase II trial data show positive survival results for BXCL701 combined with Keytruda (pembrolizumab) to treat patients with metastatic small cell neuroendocrine prostate cancer.

Interactive panel at SCOPE discussed the potential of utilizing artificial intelligence in clinical trials.

Phase IIb B-Clear trial shows bepirovirsen reduced HBsAg levels and HBV DNA following 24 weeks of treatment in patients with chronic hepatitis B.

Two multicenter, randomized, double-blind, placebo-controlled clinical trials showed that 53.1% of patients administered Eohilia achieved histologic remission compared with 1% of patients administered placebo.

The DCT-driven evolution requires new levels of understanding and expertise.

Addressing challenges with eCOA at the site-level.

While many groups rely on manual chemistry processes, innovative platforms have emerged that allow these protocols to be executed on custom automation systems.

TAK-861, an oral orexin receptor 2 agonist, will begin a Phase III trial in patients with narcolepsy type 1 later in 2024.

Samsung Biologics will provide antibody development and drug substance manufacturing services for LegoChem Biosciences' antibody-drug conjugate program with hopes of submitting an Investigational New Drug application to the FDA in 2025.

Embracing behavioral changes can lead clinical operations professionals toward driving meaningful outcomes.

Ongoing clinical development program for JNJ-2113 demonstrates promise of the novel oral therapy in treating immune-mediated inflammatory conditions.

Phase I trial results suggest the potential of Amgen's maridebart cafraglutide (MariTide) in allowing patients to take lower and less frequent doses while still maintaining significant weight loss.

Gilead announced it will discontinue the clinical development of magrolimab for hematologic cancers after the drug in combination with azacitidine plus Venclexta showed an increased risk of death related to infections and respiratory failure in patients with acute myeloid leukemia.

Despite repeated calls from the FDA, patient advocates, and scholars for the need to address demographic disparities in clinical research, White participants still remain overrepresented while racial minority participants remain underrepresented in clinical trials.

Data from the Phase I/II VERITAC trial (NCT04072952) showed promising findings for vepdegestrant in patients with ER-positive/HER2-negative locally advanced or metastatic breast cancer.

Phase III trial of acoramidis in adults with transthyretin-mediated amyloid cardiomyopathy showed positive findings for survival and hospitalizations consistent with those of global BridgeBio Phase III trial.

Phase III trial shows efficacy of Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo in the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer.