Innovative Medicine
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New STELARA® (ustekinumab) Long-Term Data Support its Established Safety Profile in Inflammatory Bowel Disease and Durable Efficacy in Ulcerative Colitis
Final cumulative pooled IBD safety data support the longstanding safety profile of STELARA across all IBD approved indications Additional long term extension data demonstrate more than half of STELARA-treated patients with ulcerative colitis achieved clinical remission, clinical response, and/or demonstrated endoscopic improvement at four years -
TREMFYA® (guselkumab) Demonstrates a Differentiated Binding Mechanism from Risankizumab in In Vitro Studies
Studies suggest mechanistic benefit of guselkumab by binding to cells that drive inflammation in the colon -
Janssen Launches Health Equity Campaign in Partnership with Award-Winning Radio Host D.L. Hughley to Raise Awareness About Multiple Myeloma Among Black Communities
That’s My Word™ campaign issues national call to action for earlier diagnosis and treatment to address the disproportionate impact of multiple myeloma among at-risk communities -
Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations
Niraparib and Abiraterone Acetate Plus Prednisone Has Potential to Address Unmet Need for Patients with BRCA-Positive mCRPC -
Janssen Receives Positive CHMP Opinion for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer
If approved, niraparib in combination with abiraterone acetate (AA), will be the first dual action tablet (DAT) available in the European Union for first-line treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations, when given with prednisone (P) or prednisolone.[i] The positive CHMP opinion is based on results from the Phase 3 MAGNITUDE study where the addition of niraparib to AA plus P significantly improved radiographic progression-free survival (rPFS) compared to standard of care in untreated mCRPC patients with BRCA1/2 mutations.[ii] -
Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
Results from the Phase 3 MAGNITUDE study second interim analysis to be featured in an oral presentation at ASCO GU -
Janssen Data at ASCO GU Support Ambition to Transform Treatment of Prostate and Bladder Cancer Through Precision Medicine and Early Intervention
Updated data from the Phase 3 MAGNITUDE study of niraparib in combination with abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer will be featured -
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Janssen Reports Positive Topline Phase 2 Results for Nipocalimab in Pregnant Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
There are currently no approved therapeutics for the treatment of HDFN which, in severe cases, can cause life-threatening anemia in the fetus