Dyne to seek accelerated approval of DMD drug on Phase I/II data
Dyne Therapeutics is seeking US accelerated approval of its Duchenne muscular dystrophy (DMD) drug after it met its endpoints in …
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Utilising real-world data to overcome challenges in rare disease research
Innovative approaches like synthetic control arms based on real-world data may help overcome the unique challenges faced in clinical trials …
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ASH 2025: MSD’s B-ALL drug shows potential, but all patients experience AEs
MSD said its newly acquired T-cell engager has demonstrated acceptable tolerability and safety in relapsed or refractory B-cell acute lymphoblastic …
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ASH 2025: Arcellx and Gilead’s Anito-cel challenges CAR-T market in R/R MM
At the American Society of Hematology (ASH) Annual Meeting 2025, held in Orlando, Florida and online from 7 to 10 …
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Kallyope’s migraine drug advances to pivotal trial
Kallyope is advancing its lead migraine drug to pivotal trials after it has shown to be competitive with marketed therapies …
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ASH 2025: Cullinan’s T-cell engager boasts potential across p53 AML subset
Cullinan Therapeutics’ T-cell engager, CLN-049, has been proven tolerable and safe in an early-stage study in relapsed or refractory acute …
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Clinical Trials Arena Excellence Awards 2025: Flex Databases
Flex Databases won the Innovation, Product Launches, and Business Expansion awards in the 2025 Clinical Trials Arena Excellence Awards for …
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Structure Therapeutics announces positive results from aleniglipron trial
Structure Therapeutics has reported positive topline results from the ACCESS clinical programme for its investigational oral glucagon-like-peptide-1 (GLP-1) receptor agonist, …
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Citryll doses first patient in Citylights trial for hidradenitis suppurativa
Citryll has dosed the first patient in the Phase IIa Citylights clinical trial of the monoclonal antibody, CIT-013, for moderate-to-severe …
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From Email Chaos to Ethical Intelligence: WCG’s CEO on the New Era of Review Management
WCG CEO Sam Srivastava explains how the company’s award‑winning ClinSphere® eReview Manager is reinventing ethics review as an AI‑enabled, interoperable, …
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Spinogenix’s Alzheimer’s drug touts disease-modifying potential in Phase IIa study
Spinogenix’s lead candidate, tazbentetol, has shown early signs of sustained, cumulative cognitive benefits in patients with mild-to-moderate Alzheimer’s disease in …
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AL-S takes mAb to Phase III after mid-stage ALS success
AL-S Pharma is planning a registrational study for its amyotrophic lateral sclerosis (ALS) monoclonal antibody (mAb), AP-101, after the drug …
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UCB’s Fintepla led to nearly 50% seizure reduction in CDD patients
UCB’s Fintepla (fenfluramine) has been associated with a nearly 50% reduction in countable motor seizure frequency (CMSF) in adult and …
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Reducing white space in early development: Four regulatory pitfalls to avoid pre-IND
In a clinical development world divided by phases, transitions are critical at every step. The transition from nonclinical testing to …
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Eli Lilly reports Phase III trial results of Jaypirca for CLL/SLL
Eli Lilly and Company has reported the outcomes from the Phase III BRUIN CLL-314 trial of Jaypirca (pirtobrutinib), a non-covalent …
