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Europe Approves First Medicine for Castleman's Disease
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Sylvant (siltuximab) for adult patients with multicentric Castleman’s disease.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Sylvant (siltuximab) for adult patients with multicentric Castleman’s disease.
Castleman’s disease is a rare disorder characterized by non-cancerous growth of the lymph nodes and related tissues. There are currently no medicinal products authorized in the European Union for its treatment.
Janssen-Cilag’s Sylvant, shown in clinical trials to reduce tumor burden and improve disease symptoms, was developed using incentives put in place by Europe’s orphan legislation. It was designated as an orphan medicine in 2007; at that time it was estimated that Castleman’s disease affected less than 1 in 10,000 people in the EU.
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
