[CLSTR]
< Back to situations

Monitor this situation.

[SITUATION] · [ACTIVE] · [HEALTH]

2 clusters · 13 sources · 8 days · First seen · Last updated

Biopharmaceutical clinical trial developments

Overview

NeuroScientific Biopharmaceuticals has cleared a regulatory hurdle with the U.S. Food and Drug Administration (FDA) for its phase two clinical trial of StemSmart cell therapy, intended for patients with treatment-resistant Crohn’s disease. The FDA approved the proposed study design and existing human clinical evidence, determining that no further non-clinical studies are required.

In separate developments, Bioxodes reported positive phase 2a results from its BIRCH trial for BIOX-101, an investigational therapy for spontaneous intracerebral hemorrhage. The data suggests the treatment may reduce secondary brain injury. Additionally, Neurocrine Biosciences has launched a Phase 2 clinical trial for NBI-567, a treatment targeting Alzheimer’s disease in adults with mild to moderate cognitive impairment.

Entities

World Stroke Congress · Nathan Smith · NeuroScientific Biopharmaceuticals · Ghent University Hospital · Neurocrine Biosciences

Timeline

  1. [HEALTH] 7 sources
    Bioxodes and Neurocrine Biosciences announce progress in neurological clinical trials

    Bioxodes reports successful phase 2a trial results for BIOX-101 in treating intracerebral hemorrhage, while Neurocrine Biosciences begins a Phase 2 trial for its Alzheimer's candidate NBI-567.

  2. [HEALTH] 5 sources
    NeuroScientific Biopharmaceuticals clears FDA hurdle for Crohn’s trial

    NeuroScientific Biopharmaceuticals received positive feedback from the FDA regarding its StemSmart cell therapy for treatment-resistant Crohn’s disease, clearing a path for phase two clinical trials.

Sources

brisbanetimes.com.au · businessday.com.au · european-biotechnology.com · mdmag.com · mugglehead.com · nen.press · news-medical.net · newsimg.bbc.co.uk · nouvelles-du-monde.com · oxfordhealth.nhs.uk · smh.com.au · theage.com.au · thewest.com.au