Thursday, June 26, 2025

Low-Dose Active-Control Trials in Psychedelic and CNS Drug Development

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This week, Compass Pathways plc (Nasdaq: CMPS) announced the successful achievement of the primary endpoint in the ongoing Phase 3 COMP005 t...
Saturday, June 14, 2025

Managing Pregnancies in Clinical Trials: Regulatory Guidance and Best Practices

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Clinical research historically has excluded pregnant women, creating major data gaps. Today, less than 1% of trial participants are pregna...
Sunday, June 08, 2025

Composite Strategy for Intercurrent Event and the Use of Trimmed Means in Clinical Trial Data Analyses

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When composite strategy is used to handle the intercurrent event (ICE), specially the terminal event such as death, the occurrence of the IC...
Thursday, June 05, 2025

Baby KJ's Story - a remarkable success of the customized CRISPR gene editing treatment

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This morning, FDA conducted a roundtable discussion on cell and gene therapies. The roundtable invited 23 panel members from the academic ...
Sunday, June 01, 2025

Forwarded: "Data Distortions: When Statistics Can Lead Us Astray in Drug Safety"

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The DIA Global Forum's article, " Data Distortions: When Statistics Can Lead Us Astray in Drug Safety ," brought attention to ...
Thursday, May 01, 2025

JSON vs SAS XPT Data Formats in Clinical Trial Data Submissions

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Regulatory study data (e.g. SDTM/SEND tabulations and ADaM analysis datasets) are currently exchanged in SAS XPORT (XPT) format, the legacy ...
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Monday, April 28, 2025

Vanda Pharmaceuticals Sues FDA Over Tradipitant Hearing Delay – A Misplaced Battle?

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This past week, Vanda Pharmaceuticals filed a federal lawsuit accusing the FDA of unlawfully delaying a hearing on the company’s new drug a...