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Single Patient Safety Concern Hits Allogene’s Off-The-Shelf CAR-T

All Of Company’s Trials Halted

 
• By Andrew McConaghie

Allogene is the frontrunner in the allogeneic CAR-T field but must assess whether or not its therapy could have caused a patient’s unexpected chromosomal abnormality.

Allogene building
The first autologous CAR-Ts gained approval in 2017, but the wait for the first allogeneic version goes on.

All of Allogene Therapeutics’ off-the-shelf CAR T therapy trials have been placed on hold by the US Food and Drug Administration after a single patient experienced a chromosomal abnormality following treatment, sending the company’s share price plunging by 42%.

The decision is another sign of the US regulator’s caution in cell and gene therapy studies and follows a string...

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• By Mandy Jackson

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Pipeline Watch: ASCO Dominates Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Quick Listen: Scrip’s Five Must-Know Things

 
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Chinese Biotech VC/PE Fundings Rise But Still Modest

 
• By Dexter Jie Yan

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