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Vertex and CRISPR Therapeutics submit BLAs to FDA for exa-cel

Pharmaceutical Technology

Formerly known as CTX001, exa-cel is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy. The BLAs are supported by data obtained from the ongoing Phase III CLIMB-111 and CLIMB-121 trials, along with an ongoing long-term follow-up CLIMB-131 trial.

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Strategies to Successfully Manage Complex Cell Therapy Clinical Trials

XTalks

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. The rapidly expanding landscape of cell therapy trials has put an operational strain on many clinical sites due to limited resources and infrastructure. “In

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Are We Getting Closer to a Herpes Vaccine?

The Pharma Data

The gene edit prevents the virus from performing its normal evasive maneuver: hiding out in nervous system cells in order to elude the immune system. And that may not be enough: One vaccine with that design failed to prevent HSV-2 infection in a clinical trial involving thousands of young women. MONDAY, Nov.

Vaccine 52
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Clinical Catch-Up: January 18-22 | BioSpace

The Pharma Data

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. Read on to see. COVID-19-Related. Non-COVID-19-Related.

Trials 52