News and Press Releases
DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible
Phase 3 PERSEUS study of daratumumab subcutaneous (SC) formulation in combination with bortezomib, lenalidomide and dexamethasone induction and consolidation, followed by daratumumab SC and lenalidomide maintenance showed a 58 percent...
Category: Drug Discovery
Posted: October 23, 2024
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Nipocalimab demonstrates sustained disease control in adolescents living with generalised myasthenia gravis in the Phase 2/3 study
First FcRn blocker to demonstrate sustained disease control over 24 weeks in antibody positive adolescents aged 12 – 17 years, broadening the population in which nipocalimab has been studied 15...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 15, 2024
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CARVYKTI® ▼ (ciltacabtagene autoleucel; cilta-cel) is the first cell therapy to significantly extend overall survival versus standard therapies for patients with multiple myeloma as early as second line
45 percent reduction in risk of death achieved with cilta-cel versus standard therapies after threeyear follow-up in landmark CARTITUDE-4 study Data featured in a late-breaking oral presentation at the 2024...
Category:
Posted: October 1, 2024
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DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
Recommendation supported by findings from quadruplet therapy PERSEUS study with daratumumab subcutaneous (SC) formulation in the frontline setting Findings showed 60 percent reduction in risk of disease progression or death...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 2024
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AC Immune Receives Second Milestone Payment Following Progress in Phase 2b ReTain Trial of ACI-35.030 in Preclinical Alzheimer’s Disease
Prescreening rate of Phase 2b ReTain trial triggers clinical development milestone payment in September Potentially registrational trial is targeting enrollment of approximately 500 participants with pre-symptomatic AD FDA Fast Track...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 17, 2024
RYBREVANT▼ (amivantamab) plus lazertinib show strong favourable overall survival trend versus osimertinib in EGFR-mutated advanced lung cancer
New longer-term data from the MARIPOSA study confirm superior outcomes of amivantamab plus lazertinib regimen compared to osimertinib monotherapy as first-line therapy Results from an interim analysis featured in late-breaker...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 8, 2024
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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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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
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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