13 December 2023
13 December 2023
The FDA draft guidance on diabetes efficacy endpoints has elicited positive response, but stakeholders and experts stress reasonability.
Even though the trial missed the primary endpoint, a predefined subpopulation of metastatic cancer patients saw an overall response rate of 51.9%.
BillionToOne will supply prenatal foetal antigen tests as a screening assay in the Phase III AZALEA trial investigating Johnson & Johnson (J&J)’s nipocalimab.
The trial of ATH-1017 failed to meet the primary goal when compared to a placebo.
Mean variation in BCVA at week 24 from baseline will be the primary efficacy endpoint of the trial.
CFT7455 monotherapy was well tolerated, with neutropenia, anaemia, and leukopenia reported as frequently seen Grade 3 or above AEs.
In the trial, treatment with OBX-115 cell therapy offered an objective response rate of 50% in trial subjects.
The device, granted investigational device exemption, is being tested in an early feasibility trial with results expected in Q1 2024.
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