News and Press Releases
Johnson & Johnson receives positive CHMP opinion for RYBREVANT▼ (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
This positive CHMP opinion establishes amivantamab as a new option, and the first fully-human EGFR-MET bispecific antibody, in the first-line treatment of EGFR exon 20 insertion-mutated NSCLC The recommendation is...
Category: Clinical Trials, Pharmaceutical
Posted: April 29, 2024
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CARVYKTI▼ (ciltacabtagene autoleucel; cilta-cel) is the first BCMA-targeted treatment approved by the EC for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
Expanded indication for this one-time infusion may provide patients with a potential period away from their multiple myeloma treatment as early as first relapse Approval is based on results from...
Category: Biotechnology, Clinical Trials
Posted: April 22, 2024
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University of Liverpool to Use Touchlight’s Rapid Enzymatic dbDNA in Fully Personalised Neoantigen Cancer Vaccine Clinical Study
The UK’s Medical Research Council is funding a 10-patient phase 1 study to deliver rapid personalised treatment for lung cancer patients 3 April 2024 -- Hampton, UK -- Touchlight, a...
Category: Biotechnology, Clinical Trials
Posted: April 3, 2024
Janssen Receives Positive CHMP Opinion for CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma
Results from the phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the potential to offer significant benefit to patients in earlier lines of treatment Most...
Category: Clinical Trials
Posted: February 23, 2024
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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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Medicines and Healthcare Products Regulatory Agencyauthorises GSK’s Omjjara (momelotinib) in Great Britainfor treating splenomegaly or symptoms in adultmyelofibrosis patients with moderate to severe anaemia
First JAK inhibitor treatment in Great Britain specifically indicated for both newly diagnosed and previously treated myelofibrosis patients with moderate to severe anaemia 31 January 2024 -- Middlesex, UK --...
Category: Pharmaceutical
Posted: January 31, 2024
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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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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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
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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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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