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Working Toward A Cure: Janssen’s Multiple Myeloma Strategy

T-cell Engagers, CAR-T Therapy Build On Darzalex Success

Executive Summary

Janssen’s Mark Wildgust explained how the Johnson & Johnson subsidiary is pushing forward with novel therapeutics and combination regimens with the goal of eliminating myeloma in the first line.

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November Could See US FDA Action On Five Breakthrough Applications, Nine Novel Agents

BioMarin’s Voxzogo, J&J’s cilta-cel and Takeda’s maribavir are among the novel agents with goal dates on US FDA’s November user fee calendar.

Cilta-Cel Reverts To Standard Review In EU

Janssen says the review at the European Medicines Agency of its marketing authorization application for cilta-cel reverted to standard timelines because the EMA wanted a GMP inspection and provision of a GMP certificate, "which did not allow continuation of the accelerated assessment timetable.”

Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: Roche shores up oncology; Janssen’s multiple myeloma strategy; gene therapy safety; a new PD-1 inhibitor moves forward in the US; and herd immunity and COVID.

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