News and Press Releases
CHMP recommends RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) after failure of prior therapy
Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, currently face a poor prognosis and limited treatment options after disease progression on osimertinib1,2,3,4 ...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: July 26, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Johnson & Johnson Receives Positive CHMP Opinion for Yuvanci® (Single Tablet Combination Therapy [STCT] of Macitentan and Tadalafil) for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
If approved, Yuvanci® would become the only single tablet combination for treatment for patients with PAH Johnson & Johnson’s comprehensive PAH portfolio has the potential to cover all guideline-recommended treatment...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: July 26, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Certa Therapeutics Receives EU Orphan Designation for FT011, a GPR68 Inhibitor Being Developed as an Anti-Fibrotic Treatment for Systemic Sclerosis
22 July 2024 -- Melbourne, Australia -- Certa Therapeutics, a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the European Medicines Agency...
Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: July 22, 2024
CHMP adopts positive opinion for BALVERSA (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
Pending approval, erdafitinib would become the first therapy targeting FGFR3 alterations in patients with metastatic urothelial carcinoma, one of Europe’s most common cancers The CHMP’s recommendation is based on results...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 28, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Kite Receives European Medicines Agency Approval of Safety Monitoring Variation for CAR T-Cell Therapy Portfolio
In-hospital patient monitoring for adverse events reduced from ten to seven days following CAR T-cell therapy infusion 6 June 2024 -- Stockley Park, UK -- Kite, a Gilead Company, today...
Category: Biotechnology, Other, Pharmaceutical
Posted: June 6, 2024
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
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
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
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
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
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
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
Friedrich-Ebert-Str. 475 / Building 302 42117 Wuppertal Germany
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
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
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
