Innovative Medicine
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Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma
Additional long-term data from the TRiMM-2 study in patients receiving talquetamab and DARZALEX FASPRO® combination biweekly regimen showed an overall response rate of more than 80 percent -
TREMFYA® (guselkumab) Provides Sustained Improvements Across All Minimal Disease Activity Domains for Adults Living with Active Psoriatic Arthritis in Phase 3b Trial
Additional post-hoc clinical data will be presented from Phase 3 DISCOVER trials providing clinical insights on the importance of shared decision making to address patient-reported symptoms -
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guidelines-recommended treatment pathways -
Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation
The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development program to date and will provide extensive data from nearly 50,000 patients, with all three studies underway -
Janssen to Highlight Scientific Advances and Commitment to Transform Cancer Care at ASCO and EHA with More than 90 Presentations Showcasing Robust, Differentiated Portfolio and Pipeline in Hematologic Malignancies and Solid Tumors
Launch of Multidisciplinary Council of Experts Call-to-Action During EHA Demonstrates Continued Commitment to Innovation in Multiple Myeloma -
First Phase 3 TREMFYA® (guselkumab) Data in Inflammatory Bowel Disease Show Positive Induction Results Among Patients with Moderately to Severely Active Ulcerative Colitis
Late-breaking data from the Phase 3 QUASAR Induction Study show statistically significant and clinically meaningful improvements among ulcerative colitis patients, including bio-naïve patients and those who have experienced treatment failure with advanced therapies -
Janssen Enters Worldwide Collaboration and License Agreement with Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies
Investigational CD20-targeted CAR-Ts Enhance Janssen’s B-cell Malignancy Portfolio Agreement Deepens Janssen’s Leadership in Oncology and Hematology, and Accelerates Commitment to Delivering Transformational Cell Therapies -
Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer
Study results of novel drug-eluting technology highlight potential durability of TAR-200 in patient population with high unmet need -
Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations
Approval for AKEEGA® is based on results from the Phase 3 MAGNITUDE study, a prospectively designed precision medicine study that includes the largest cohort to date of BRCA1/2-positive patients with untreated metastatic castration-resistant prostate cancer (mCRPC).1,2 Niraparib in combination with abiraterone acetate (AA), plus prednisone or prednisolone, significantly improved radiographic progression-free survival (rPFS) compared to standard of care in untreated mCRPC patients with BRCA1/2 mutations.3