News

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.

A pivotal Phase III clinical trial is currently evaluating treatment with rusfertide, a potential first-in-class treatment for polycythemia vera.

In the 72-week BALATON and COMINO trials, Vabysmo (faricimab-svoa) produced sustained retinal drying and improved vision in patients with retinal vein occlusion.

Leveraging a “diversity by design” approach can build patient narratives and optimize protocols from the onset.

Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone for induction and consolidation therapy and in combination with maintenance lenalidomide found to improve survival in patients with multiple myeloma who are eligible for autologous stem cell transplant.

The Padcev/Keytruda combination produced statistically significant and clinically meaningful improvements to survival compared to platinum-containing chemotherapy in first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer.

In an interview with ACT editor Andy Studna, Jim Reilly, VP, R&D Strategy, Veeva Systems, discusses ways stakeholders can select the best solutions available in clinical trials.

Recent study tests the ability of machine learning to effectively classify patient safety event reports.

The FDA has cleared an investigational new drug application and granted Fast Track designation to ACDN-01, the only clinical-stage therapeutic targeting the genetic cause of Stargardt disease.

Phase II TRANSCEND FL and Phase I TRANSCEND NHL 001 trial data lead to FDA Priority Review designation for Breyanzi to treat relapsed or refractory follicular lymphoma and mantle cell lymphoma.

Intravenous immunoglobulin Gammagard Liquid approved by the FDA to treat neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy.

The pursuit of balance between data utility, privacy protection, and equitable representation.

Monthly, higher doses of novel therapy SRP-5051 (vesleteplirsen) found to produce substantially greater increases in dystrophin and exon skipping compared to the lower weekly dose.

Trial shows Keytruda improved overall survival by 38% compared with placebo in in patients with renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy or nephrectomy and resection of metastatic lesions.

The Priority Revew designation was based on findings from the ongoing, global, multicenter, multi-cohort, open-label Phase II DESTINY-PanTumor02 trial of of Enhertu for patients with previously treated HER2-expressing tumors, including biliary tract cancer, bladder cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and other tumor types.

In an interview with ACT editor, Andy Studna, Lieberman, Executive Director, Conferences (CHI) & Co-Founder, VP, Community and Business Development (ClinEco) discusses the Summit for Clinical Ops Executives (SCOPE) conferences in Europe and the US.

By promoting the use of a standardized terminology and coding system, IDMP eliminates inconsistencies in regulatory processes.

A deep dive into the complex playing field for M&A and partnering pursuits in today’s increasingly make-or-break landscape for biopharma innovation.

Testing in humans in clinical trials and the regulatory approval process itself are candidates for technology solutions where artificial intelligence is playing a role.