FDA’s DCT draft guidance: A hit or miss?
The much-anticipated draft guidance on DCTs is here, however, it might have missed several important points on delegation and data management.
05 July 2023
05 July 2023
The much-anticipated draft guidance on DCTs is here, however, it might have missed several important points on delegation and data management.
Oxford BioTherapeutics expanded its US-based trial investigating OBT-076 as monotherapy and combination treatment to European sites.
The subcutaneous drug could be used to treat patients with Crohn’s disease and ulcerative colitis.
Patients receiving nemolizumab reached an itch-free state quicker than placebo.
Sensorion has reported that its hearing loss drug candidate SENS-401 has met secondary endpoints in a phase IIa proof of concept trial.
BP02 showed a similar clinical response compared to Herceptin.
A well-tolerated safety profile of ICP-488 was demonstrated in a Phase I clinical trial.
The Safety Committee evaluated data, including descriptions of adverse events.
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