News

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.

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.

In an interview with ACT Editor Andy Studna, Jim Reilly, VP, R&D Strategies, Veeva Systems, discusses improving collaborations with research sites and provides an outlook of how the new year looks for clinical trials.

Blenrep with bortezomib plus dexamethasone produced a significant improvement to median progression-free survival in the treatment of relapsed or refractory multiple myeloma compared with standard of care combination therapy.

Study indicated that nipocalimab demonstrated significant improvements in the symptoms of generalized myasthenia gravis and Sjögren's disease.

The ongoing Phase I/II NCT05438329 trial is evaluating BNT325/DB-1305 in patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer previously administered one to three systemic treatment regimens.

The supplemental Biologics License Application for Arexvy was based on positive data from the Phase III NCT05590403 trial, which analyzed the immune response and safety of Arexvy in individuals 50-59 years of age with an elevated risk of respiratory syncytial virus-related lower respiratory tract disease.

Data from the Phase II Nivolumab and Ipilimumab Plus/minus UV1 vaccination (NIPU) clinical trial show UV1 off-the-shelf cancer vaccine plus ipilimumab (Yervoy) and nivolumab (Opdivo) improved survival in patients with unresectable malignant pleural mesothelioma.

Final results from inspIRE study demonstrate 80% freedom from atrial arrhythmia recurrence at 12 months; early results from admIRE study suggest similar outcomes.

Efineptakin alfa, the only clinical stage long-acting human interleukin-7, is currently being evaluated in Phase I/II clinical trials in combination with pembrolizumab (Keytruda) for patients with advanced solid tumors, including pancreatic cancer.

Ensuring equitable access to new technologies and integrating AI to benefit all communities remain critical challenges to overcome.

In an interview with ACT Associate Editor Don Tracy, Shubh Goel, Head of Immuno-Oncology and Gastrointestinal Tumors, US Oncology Business Unit, AstraZeneca, provides her thoughts on the success of the trial.

NeuroBo Pharmaceuticals’ DA-1726 showed persistent weight loss in preclinical studies.

Biosyngen’s BST02 is a cell-based immunotherapy that began clinical trials in October 2023 for all types of liver cancer.

Afami-cel was developed to target the MAGE-A4 protein in synovial sarcoma, which comprises 5% to 10% of soft tissue sarcomas.

The manufacturing process for CAR T-cell therapies is vital in preparing a patient’s cells for a one-time cell therapy infusion that is specifically tailored to meet each patient’s needs.

Howell shares important insights from the most recent J.P. Morgan Healthcare Conference and addresses where the clinical trials industry currently is with innovation.

Research collaboration between DELFI and Immunocore Holdings will investigate the potential of the DELFI-TF assay in predicting the efficacy of ImmTAC-based treatments early in the therapy process.