Kayentis and RWS partner to improve clinical trial data reliability in CNS studies
Integrated eCOA technology and rater training aim to reduce variability and strengthen ClinRO outcomes
Integrated eCOA technology and rater training aim to reduce variability and strengthen ClinRO outcomes
The CE Mark builds on the company’s ISO 13485 certification, further strengthening confidence in the platform's safety, quality and performance
The upcoming multi-center, multinational Phase 1 study will evaluate safety, tolerability, pharmacokinetics, and early signs of efficacy
Move amid evidence of widespread reporting gaps
BioNTech will supply pumitamig, a PD-L1/VEGF-A bispecific antibody co-developed with Bristol Myers Squibb, while Boehringer Ingelheim will act as the regulatory sponsor of a Phase Ib/II study
Outlines 1,500-member internal cadre, digital regulatory system, and faster SEC-led reviews
Benefits were consistent across all key subgroups, including patients previously treated with covalent BTK inhibitors
Highlights Mirvetuximab-based regimen promise
The study is a global, randomized, double-blind, placebo-controlled trial testing GLM101 for phosphomannomutase 2 congenital disorder of glycosylation
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