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Janssen Biotech Inc.

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Latest From Janssen Biotech Inc.

Kite Can Reach Two-Week Yescarta Turn-Around Time After Manufacturing Change

The streamlined process is expected to shorten the turn-around for the CAR-T therapy to about the same time as from an office visit to front-line cancer treatment, Kite Pharma said.

Gene Therapy Manufacturing

Kite’s Tecartus Boxed Warning Will More Closely Resemble Other CAR-Ts After FDA Changes Course

Tecartus label still will not state that secondary malignancy cases have been reported in patients who received the product. CBER officials also address causality questions in a NEJM paper.

Gene Therapy Safety

CAR-Ts Getting Boxed Warning On Secondary Malignancies Despite Sponsor Causation Questions

Sponsors still say they have no evidence the CAR-Ts cause secondary malignancy even though US FDA ordered their labels updated with a boxed warning of the adverse event. Tecartus label will not state that postmarketing secondary malignancies have been found in patients using the product.

Gene Therapy Safety

ADC Specialist LegoChem Takes Orion’s Hand As Long-Term Partner

Korean confectionery group Orion has become the biggest shareholder in compatriot ADC specialist LegoChem Biosciences, in a decisive step to move into the biotech sector as a new growth engine. For LegoChem, the alliance provides a friendly strategic partner and should enable a boost in R&D spending as it seeks to aggressively progress clinical trials and become a global player.

South Korea M & A
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