News and Press Releases
European Commission Approves Astellas’ PADCEVTM (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer
First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years European Marketing Authorization based on positive overall survival and...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: August 28, 2024
European Commission approves RYBREVANT®▼ (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
Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, have until now faced a poor prognosis and limited treatment options after disease progression on...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: August 27, 2024
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European Commission approves BALVERSA®▼ (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma
First pan FGFR kinase inhibitor to be approved in the European Economic Area, for adults with unresectable or metastatic urothelial carcinoma and susceptible FGFR3 alterations Approval based on THOR results,...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: August 23, 2024
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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
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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
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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
RYBREVANT (amivantamab) in combination with chemotherapy is the first therapy approved by the European Commission for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
Approval is supported by the phase 3 PAPILLON study, which showed amivantamab plus chemotherapy significantly reduced the risk of disease progression or death by 60% compared to chemotherapy alone 28...
Category: Clinical Trials, Pharmaceutical
Posted: June 28, 2024
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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
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Pharmaceutical Powerhouse: Johnson & Johnson
is once again the world's most valuable and strongest pharma brand New data from Brand Finance reveals impact of restructuring and M&A activity on brand values across the Healthcare Sector...
Category: BioManufacturing, Biotechnology, Other
Posted: June 18, 2024
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
CARVYKTI▼ (ciltacabtagene autoleucel; cilta-cel) significantly improved progression-free survival and deepened responses versus two standard therapies for patients with functional high-risk multiple myeloma
73% reduction in risk of disease progression or death seen with cilta-cel in the CARTITUDE-4 study in a subset of patients who had early relapse after initial multiple myeloma therapy...
Category: Biotechnology, Clinical Trials, Drug Discovery
Posted: June 4, 2024
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TECVAYLI▼ (teclistamab) shows sustained deep and durable responses in patients with relapsed or refractory multiple myeloma
New MajesTEC-1 data show a median duration of response of 24 months, with responses deepening, including in patients who switched to biweekly dosing Separate analyses from the MajesTEC-1 and OPTec...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 3, 2024
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DARZALEX (daratumumab)-based regimens significantly improved clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma
88% of transplant-eligible patients achieved a complete response or better, and 47% of patients sustained MRD-negativity for longer than one year with daratumumab subcutaneous formulation-based regimens in the phase 3...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 3, 2024
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Johnson & Johnson submits application to the European Medicines Agency seeking approval of subcutaneous formulation of RYBREVANT▼ (amivantamab) for the treatment of patients with EGFR-mutated non-small cell lung cancer
Submission is supported by data from the phase 3 PALOMA-3 study featured at the American Society of Clinical Oncology (ASCO) Annual Meeting New formulation showed non-inferiority to intravenous administration in...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: May 31, 2024
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RYBREVANT▼ (amivantamab) plus lazertinib shows longer progression-free survival versus osimertinib in the first-line treatment of patients with high-risk EGFR-mutated non-small cell lung cancer
Investigational chemotherapy-free regimen of amivantamab plus lazertinib addresses a significant unmet need as most patients with EGFR-mutated NSCLC have high-risk disease Landmark phase 3 MARIPOSA data featured in an oral...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: May 31, 2024
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