News and Press Releases
Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Lazertinib, in combination with RYBREVANT (amivantamab), for the First-Line Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer
The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO CongressLazertinib is a highly selective, central...
Category: Clinical Trials
Posted: December 21, 2023
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DARZALEX (daratumumab) Subcutaneous Formulation-based Quadruplet Therapy Regimen Shows Significant Improvement in Outcomes for Patients with Transplant-eligible Newly Diagnosed Multiple Myeloma
Daratumumab subcutaneous-based induction, consolidation and maintenance regimen reduced risk of progression or death by 58 percent compared to standard of care regimenFirst presentation of data from Phase 3 PERSEUS study...
Category: Clinical Trials
Posted: December 13, 2023
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
New Data Presented at ASH from the Phase 3 GLOW Study Show Fixed-Duration, First-Line Treatment with IMBRUVICA (ibrutinib) Plus Venetoclax Demonstrated an Overall Survival Rate of More Than 84% at 54 Months in Patients with Chronic Lymphocytic Leukaemia
Additional data from the phase 2 CAPTIVATE study, show 82% of patients with previously untreated chronic lymphocytic leukaemia (CLL) treated with fixed-duration ibrutinib plus venetoclax did not need next-line treatment...
Category: Clinical Trials
Posted: December 11, 2023
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Janssen Submits Application to the European Medicines Agency forRYBREVANT▼ (amivantamab) in Combination with Chemotherapy for the Treatment of Adult Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer After Failure of Prior Therapy
The submission is supported by data from the Phase 3 MARIPOSA-2 study featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress and simultaneously published in Annals of...
Category: Clinical Trials
Posted: November 23, 2023
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Landmark Phase 3 MARIPOSA Study Shows RYBREVANT▼(amivantamab) Plus Lazertinib Resulted in 30% Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients with EGFR-Mutated NSCLC
Early data show an overall survival trend favoring the combination of amivantamab and lazertinib compared to osimertinib; consistent results seen in patients with and without brain metastases Late-breaking results from...
Category: Clinical Trials
Posted: October 24, 2023
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Results from Phase 2 THOR-2 Study Showed Improved Rates of Recurrence-Free Survival in Patients with High-Risk Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations Treated with Erdafitinib Versus Chemotherapy
Data from Cohort 1 of the phase 2 THOR-2 study showed oral erdafitinib reduced the risk of disease recurrence or death compared with intravesical standard-of-care chemotherapy 21 October 2023 --...
Category: Clinical Trials
Posted: October 23, 2023
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
European Commission Approves ADCETRIS (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD
· Approval Based on Updated Positive Overall Survival Results from the phase 3 ECHELON-1 Study for Stage III & IV Hodgkin Lymphoma · First Significant Improvement in Overall Survival in Two Decades...
Category: Pharmaceutical
Posted: October 23, 2023
Mundipharma and Cidara Therapeutics receive positive CHMP opinion forrezafungin for the treatment of Invasive Candidiasis in adults
The opinion was based on positive results from the pivotal ReSTORE phase 3 clinicaltrial and supported by the STRIVE phase 2 clinical trials and extensive nonclinicaldevelopment programme If approved by...
Category: Biotechnology
Posted: October 17, 2023
pharmaand GmbH Receives Positive CHMP Opinion for Rubraca (rucaparib) as a First-Line Maintenance Treatment in Advanced Ovarian Cancer
CHMP positive opinion based on the results from Phase 3 ATHENA-MONO trial European Commission (EC) approval decision expected in the coming months This is the first rucaparibregulatory milestone since being...
Category: Pharmaceutical
Posted: October 17, 2023
MSD’s WELIREG▼(belzutifan) made available for the treatment of eligible adults with von Hippel-Lindau (VHL) disease in Scotland
Scotland is the first European country to accept belzutifan as a treatment for adult patients with von Hippel-Lindau (VHL) disease who require therapy for VHL-associated renal cell carcinoma (RCC), central...
Category: Pharmaceutical
Posted: October 9, 2023
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New Safety Data Suggests SPRAVATO▼ (Esketamine Nasal Spray) is More Tolerable and Effective Compared to Quetiapine Extended-Release (XR) in Adults with Treatment-resistant Major Depressive Disorder
• The new safety data is from the ESCAPE-TRD Phase 3b study• Additional findings from this study showed esketamine NS demonstrated a significant increase in the proportion of patients achieving...
Category: Clinical Trials, Drug Discovery
Posted: October 9, 2023
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Janssen Submits MA Application to the European MedicinesAgency Seeking Approval of Erdafitinib for the Treatment of Patients with LocallyAdvanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations
Pending approval, erdafitinib, an investigational, once-daily oral pan-fibroblast growth factorreceptor (FGFR) tyrosine kinase inhibitor, will become the first therapy targeting FGFRalterations in patients with metastatic urothelial carcinoma, one of Europe’s...
Category: Clinical Trials, Drug Discovery
Posted: September 8, 2023
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