Working Toward A Cure: Janssen’s Multiple Myeloma Strategy
T-cell Engagers, CAR-T Therapy Build On Darzalex Success
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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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.
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.”
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.