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
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
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.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Companies with significant exposure to Medicare and Medicaid have fewer options for passing along higher costs to consumers because of price controls in the programs.
The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.
There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.
