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LAKE FOREST, Ill. — Jaguar Gene Therapy a biotechnology company accelerating breakthroughs in gene therapy for patients suffering from severe genetic diseases, including those that affect sizeable patient populations, today announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) Application for JAG201, a...
BEERSE, Belgium – The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX® ▼(daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly...
The Food and Drug Administration (FDA) has updated the fact sheet for the Janssen COVID-19 vaccine to include information related to the potential increased risk of developing Guillain-Barré syndrome. Guillain-Barré syndrome is a rare neurological disorder in which the body’s immune system damages nerve cells causing muscle weakness and sometimes...
BEERSE, Belgium – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that new data for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, demonstrated sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM).[1] Updated results from the Phase 1b/2 CARTITUDE-1...
BEERSE, Belgium – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of...