53+ min ago   (251+ words) Acepodia has secured the US Food and Drug Administration (FDA) clearance of an investigational new drug (IND) application for ACE723, allowing it to begin a Phase I clinical trial in patients with unresectable or metastatic hepatocellular carcinoma (HCC). GPC3 is a tumour-associated…...

3+ day, 23+ hour ago   (408+ words) Markel Insurance has launched a reimbursement scheme to help boost enrolment for international trials evaluating rare disease therapies. The enhancement is purchased by trial sponsors and reimburses eligible travel-related expenses for approved participant travel to and from clinical trial sites....

4+ day, 44+ min ago   (285+ words) Treeline Biosciences has signed a clinical trial collaboration and supply agreement with Roche for a Phase I study assessing the combination of Treeline’s BCL6 degrader, TLN-121, with Roche’s CD20×CD3 T-cell-engaging bispecific antibodies, glofitamab (Columvi) and mosunetuzumab (Lunsumio), in patients with B-cell lymphomas…...

4+ day, 18+ hour ago   (336+ words) While Teva announced positive Phase II data, it has not yet confirmed Phase III plans. Teva’s investigational anti-interleukin-15 monoclonal antibody (mAb) has met its primary endpoint in a Phase IIa trial in celiac disease. Jeffries analysts touted that TEV ‘408’s…...

5+ day, 45+ min ago   (415+ words) The Phase III study randomises GA patients in 2:1 ratio to receive either OCU410 or no treatment. Ocugen has initiated its global Phase III ArMaDa3 trial of OCU410, an investigational gene therapy for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD), with…...

5+ day, 17+ hour ago   (374+ words) Through the pilot, stakeholders can secure access to feedback on their NAM from non-clinical experts. The European Medicines Agency (EMA) has debuted a new voluntary pilot scheme designed to help preclinical toxicologists secure feedback on data generated from new approach…...

5+ day, 1+ hour ago   (270+ words) The trial will administer BHB810 to patients with advanced gastric and gastroesophageal tumours. BigHat Biosciences has dosed the patient in a Phase I clinical trial of BHB810, an antibody-drug conjugate targeting Cadherin-17 (CDH17), for the treatment of gastric cancer and other advanced gastrointestinal…...

5+ day, 20+ hour ago   (487+ words) In Association with Thermo Fisher Scientific As licensing expands, manufacturing evidence is becoming a decisive test of asset value and deal confidence. This is increasingly important as pharmaceutical companies look outside their own laboratories for pipeline growth, and chemistry, manufacturing,…...

5+ day, 20+ hour ago   (79+ words) Clinical Trials Arena Unlock FREE Access to Premium Content ​Discover exclusive forecasts, analyst insights, and in-depth clinical trials industry analysis across drug development, clinical research, and trial innovation. With a free Clinical Trials Arena profile, you can: - View premium forecasts…...

5+ day, 20+ hour ago   (407+ words) The company progresses its mRNA-based candidate just under a month after Moderna won FDA approval for the first seasonal flu mRNA vaccine. GSK’s seasonal, mRNA-based influenza vaccine is progressing to a Phase III study after securing a safety and efficacy…...