News and Press Releases
Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe
FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH) ODD status may expedite drug candidate development and approvals BIOX-101 interim Phase 2a data in ICH imminent. 5...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 5, 2025
Kite Presents New Data on Patient Outcomes with CAR T-Cell Therapy at the 7th European CAR T-Cell Meeting, 6-8 February, Strasbourg, France
6 February 2025 -- Stockley Park, UK -- Kite, a Gilead Company, will share four posters that add to the growing body of evidence to support the clinical use of...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 6, 2025
CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 3, 2025
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CHMP recommends RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
The amivantamab plus lazertinib combination regimen offers potential to provide new standard of care as first-line option for adult patients with advanced NSCLC with EGFR ex19del or L858R substitution mutations...
Category: Clinical Trials
Posted: November 20, 2024
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Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO®/DARZALEX® (daratumumab) as subcutaneous monotherapy for high-risk smouldering multiple myeloma
If approved, daratumumab will become the first treatment option for patients with smouldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: November 8, 2024
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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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Duke Street Bio Granted Approval by European Medicines Agency to Launch Next-Generation PARP1-Selective Inhibitor Trial
24 September 2024 -- London, UK -- Duke Street Bio Ltd, a precision medicine biotech developing next generation small molecule cancer therapies, is pleased to announce that the European Medicines...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 24, 2024
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old
Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescents...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 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 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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