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Celyad gets the go-ahead to resume CAR-T trial for colorectal cancer as FDA lifts hold

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Four months ago, the FDA placed a clinical hold on Celyad’s CAR-T trial for colorectal cancer after two patients died during the study. Regulators have now lifted the hold, allowing the Belgian company’s trial to set sail once again.

Source
Endpoints

FDA quickly follows a voluntary pause for CAR-T 2.0 with a clinical hold to investigate 2 patient deaths

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Celyad’s voluntary pause didn’t last long.

The biotech put out word after the market closed Monday that the FDA has swiftly followed up the news of 2 patient deaths and an announced pause with a clinical hold, shifting control over the trial halt to federal regulators.

Source
Endpoints

The Week Ahead In Biotech: Pending Clinical Readouts In Focus

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Biotech stocks headed south last week, reversing decent gains made in the previous week. Unfavorable FDA decisions, botched trials and weaker broader market sentiment all weighed down on the sector.

Here are the key catalysts of the unfolding week.

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Yahoo/Benzinga