2023 in review: Are clinical trial sponsors and regulators in sync?
Decentralisation, diversity, new trial systems and transparency rules made a mark in 2023, but increasing pressure on sponsors may backfire.
19 December 2023
19 December 2023
Decentralisation, diversity, new trial systems and transparency rules made a mark in 2023, but increasing pressure on sponsors may backfire.
In the trial, the safety profile of the dostarlimab-chemotherapy-niraparib regimen was in line with already reported data.
The TROPION-Breast04 trial will enrol 1,700 subjects at trial centres in South America, North America, Oceania Asia, and Europe.
The FDA has requested additional information on long-term potency after the Phase II trial was first put on clinical hold due to manufacturing issues in 2022.
Global sales in the atopic dermatitis (AD) market are forecasted to grow to $16.7bn by 2030.
The first Phase II expansion cohorts will concentrate on renal cell carcinoma and melanoma.
The trial failed to meet the primary endpoint and crucial secondary endpoints.
Both the European Commission and the US' Federal Trade Commission have taken issue with Illumina’s reacquisition of Grail.
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