SCOPE: FDA facilitates AI and ML use for clinical trials and drug development
Two FDA representatives FDA spoke at the ongoing 2024 SCOPE Summit about how the agency is focusing on AI.
14 February 2024
14 February 2024
Two FDA representatives FDA spoke at the ongoing 2024 SCOPE Summit about how the agency is focusing on AI.
Grifols’s Phase III AdFIrst trial met its primary endpoint.
The company is initially focusing on developing alisertib for small-cell lung cancer and breast cancer.
The trial will assess the safety and tolerability of OLX75016 in a randomised, double-blind, placebo-controlled setting.
The study is due to begin in the first half of this year, with data readout expected next year.
The trial of sebetralstat met all its primary and secondary endpoints.
The biotech believes cyclisation of its candidate gives it an advantage over already marketed mitogen-activated protein kinase (MEK) inhibitors.
LDL-C reduction was observed in 43.3% of patients dosed every two weeks and 33.8% in patients dosed every four weeks.
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