Sanofi-Synthelabo's recombinant urate-oxidase enzyme Elitek (rasburicase) is approved July 12 for "initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid." Phase IV commitments include development of a validated immunogenicity assay, collecting serum samples from all study patients until the assay is developed, a study in at least 150 patients assessing repetitive treatment with rasburicase, and a study comparing the approved dose and schedule of rasburicase with a regimen of sequential rasburicase and allopurinol, a competing product indicated for hyperuricemia. Sanofi plans to launch Elitek in mid-August. The firm projects worldwide sales will reach EUR 100 mil. in 2005; rasburicase was launched in Europe in 2001 under the brand Fasturtec
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
