Sep 18, 2022First Person Dosed in Novel Gene Editing Clinical TrialVerve Therapeutics announced today (July 12) that it has dosed the first participant in a clinical trial assessing the safety and tolerability of the gene editing platform VERVE-101, which uses a precise kind of gene editing called base editing. …4 min read4 min read
Sep 11, 2022How Patient-Centered Strategies Are Transforming Clinical TrialsSeptember 2, 2022 | Patient centricity is a term on everyone’s lips right now, and with good reason. The life science sector is coming round to the idea that, by putting the needs of the patient at the heart of drug development, we can improve the patient experience and reduce…5 min read5 min read
Sep 4, 2022A Blended Solution-How Midsize Pharmaceutical and Biotech Companies Can Optimize the Delivery of Their Clinical TrialsAugust 12, 2022 | Traditionally, biopharma companies use two outsourcing models to deliver their clinical trial portfolios. First, the Contract Research Organization (CRO) model creates a 1:1 relationship between a project and a project contract. Second, the Functional Service Provider (FSP) model leverages economies of scale, allowing the company to…3 min read3 min read
Sep 1, 2022Study shows encouraging therapeutic options for patients with relapsed multiple myelomaMount Sinai researchers have published results that show encouraging therapeutic options for patients with the blood cancer multiple myeloma after first-line treatment with bispecific antibodies fails. …3 min read3 min read
Aug 18, 2022CSL reports Phase III data for garadacimab to treat hereditary angioedemaCSL has reported positive top-line data from the Phase III VANGUARD clinical trial of garadacimab (CSL312) as a durable preventive therapy for hereditary angioedema (HAE) patients. The double-blind, multicentre, randomised, parallel-arm, placebo-controlled trial analysed the safety and efficacy of subcutaneous garadacimab given monthly to prevent HAE attacks versus a placebo…2 min read2 min read
Aug 18, 2022CSL reports Phase III data for garadacimab to treat hereditary angioedemaCSL has reported positive top-line data from the Phase III VANGUARD clinical trial of garadacimab (CSL312) as a durable preventive therapy for hereditary angioedema (HAE) patients. The double-blind, multicentre, randomised, parallel-arm, placebo-controlled trial analysed the safety and efficacy of subcutaneous garadacimab given monthly to prevent HAE attacks versus a placebo…2 min read2 min read
Jul 31, 2022Tufts Study Provides ‘First Hard Metrics’ Around Decentralized Clinical TrialsThe economic savings, as revealed by a newly completed Tufts CSDD study, come from reduced cycle times, improved patient screening and enrollment, and fewer protocol amendments over the life of a trial. …8 min read8 min read
Jul 21, 2022Yuyu Pharma begins subject enrolment in Phase II dry eye disease studyYuyu Pharma has enrolled the first participant in a Phase II clinical study of YP-P10 Ophthalmic Solution to treat dry eye disease (DED). YP-P10 is a new and patented synthetic peptide that has anti-inflammatory and wound healing properties which help in treating DED. It was developed by Yuyu Pharma R&D…2 min read2 min read
Jul 20, 2022Cardurion begins subject dosing in Phase II heart failure trialCardurion Pharmaceuticals has started dosing of subjects in CARDINAL-HF, a Phase II clinical trial of its phosphodiesterase-9 (PDE9) inhibitor, CRD-740, to treat heart failure. The company also announced that multiple sites for the trial are opened. The randomised, placebo-controlled CARDINAL-HF trial is said to be the first Phase II proof-of-concept…2 min read2 min read
Jul 20, 2022Capricor doses first subject in Phase III Duchenne muscular dystrophy trialCapricor Therapeutics has dosed the first subject in the Phase III HOPE-3 clinical trial of cell therapy, CAP-1002, to treat late-stage Duchenne muscular dystrophy (DMD). CAP-1002 comprises allogeneic cardiosphere-derived cells (CDCs), a kind of progenitor cell. The double-blind, randomised, placebo-controlled trial will enrol nearly 70 subjects in the US. Trial…3 min read3 min read
