News and Press Releases
Real-World Evidence Demonstrates Feasibility and Safety of Outpatient Administration of Yescarta (axicabtagene ciloleucel)
Findings show comparable safety for patients administered axicabtagene ciloleucel in the outpatient setting in the US to inpatient infusion Real-world evidence supports further exploration of use of outpatient administration of...
Category: Clinical Trials
Posted: February 15, 2024
Janssen Submits Type II Extension of Indication Application to the European Medicines Agency Seeking Approval of RYBREVANT (amivantamab), in combination with Lazertinib, 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, showing statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with...
Category: Drug Discovery
Posted: February 8, 2024
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AiCuris Received €15m Milestone Payment from Licensing Partner MSD Following EMA Approval of PREVYMIS for Prevention of CMV Infection in High-Risk Adult Kidney Transplant Recipients
PREVYMIS now approved in the US and Europe for prophylaxis of Cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) EMA approval...
Category: Pharmaceutical
Posted: January 9, 2024
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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
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ViroCell signs manufacturing services agreement with UCL to accelerate research into prevention of relapse in childhood blood cancer
Agreement will leverage ViroCell’s expertise in lentiviral vector manufacturing for an innovative CAR T-cell therapy for the treatment of paediatric acute lymphoblastic leukaemia 12 December 2023 -- London, UK and...
Category: BioManufacturing
Posted: December 12, 2023
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
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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
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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
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Kite’s CAR T-Cell Therapy YESCARTA (Axicabtagene Ciloleucel) Compared with Bispecifics in R/R DLBCL in Two Analyses at ESMO 2023
23 October 2023 -- Stockley Park, UK -- Kite, a Gilead Company, today announced results from two indirect comparative analyses of its CAR T-cell therapy Yescarta (axicabtagene ciloleucel) versus bispecific...
Category: Clinical Trials
Posted: October 23, 2023
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
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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
Kite’s CAR T-Cell Therapy Accepted for Use on the NHS in Scotland to Treat Aggressive Form of Blood Cancer
First CAR T-cell therapy for adult (26+) patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL) reimbursed in Scotland 9 October 2023 -- London, UK -- Gilead Sciences...
Category: Pharmaceutical
Posted: October 9, 2023
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
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