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Acadia Pharmaceuticals begins trial of Alzheimer’s psychosis drug
US-based biotechnology company Acadia Pharmaceuticals has begun a Phase II clinical trial of ACP-204 to treat hallucinations and delusions linked to Alzheimer’s …
TC BioPharm receives FDA approval for AML cell therapy trial
The US Food and Drug Administration (FDA) has granted clearance for TC BioPharm’s investigational new drug (IND) application to begin a …
Roivant and Priovant’s lupus drug fails to meet trial endpoint
Roivant and Priovant have reported that their Phase II clinical trial of oral brepocitinib to treat adults with moderate to severe systemic …
FDA grants IDE to RTI Surgical for breast reconstruction device trial
The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to RTI Surgical’s allograft dermis, opening the …
Post-ventilation study wins Australian Clinical Trial of the Year Award
A clinical trial examining the use of early mobilisation as a treatment for invasively ventilated adults has been awarded Clinical …
FDA rejects Aldeyra’s dry eye drug, asks for more clinical data
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Aldeyra Therapeutics regarding its new …
Xenon Pharmaceuticals reports data from trial of MDD therapy
Canadian pharmaceutical company Xenon Pharmaceuticals has reported topline data from the Phase II X-NOVA clinical trial of XEN1101 to treat patients with …
Acadia Pharmaceuticals begins trial of Alzheimer’s psychosis drug
US-based biotechnology company Acadia Pharmaceuticals has begun a Phase II clinical trial of ACP-204 to treat hallucinations and delusions linked to Alzheimer’s …
TC BioPharm receives FDA approval for AML cell therapy trial
The US Food and Drug Administration (FDA) has granted clearance for TC BioPharm’s investigational new drug (IND) application to begin a …
Roivant and Priovant’s lupus drug fails to meet trial endpoint
Roivant and Priovant have reported that their Phase II clinical trial of oral brepocitinib to treat adults with moderate to severe systemic …
FDA grants IDE to RTI Surgical for breast reconstruction device trial
The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to RTI Surgical’s allograft dermis, opening the …
Post-ventilation study wins Australian Clinical Trial of the Year Award
A clinical trial examining the use of early mobilisation as a treatment for invasively ventilated adults has been awarded Clinical …
External controls can augment low populations in rare disease trials
Data collection has been an integral part of conducting clinical trials. With the introduction of new technologies such as machine …
How quality clinical monitoring oversight ensures the success of clinical trials
With the goal of ensuring issues with site misconduct are identified and addressed before problems occur, clinical monitoring is an …
Sanofi and Regeneron’s Dupixent scores second win in Phase III COPD trial
Sanofi and Regeneron have reported positive interim data from the Phase III NOTUS trial with Dupixent (dupilumab) showing a 34% …