Idec Zevalin
Idec agrees to market lymphoma radioimmunotherapy Zevalin (ibritumomab) in two kits - an imaging kit with indium and a therapeutic kit with yttrium - as requested in FDA "complete review" letter. Idec will also submit analyses of hospitalization and cytopenia seen in clinical trials, as well as manufacturing information. The company will respond to FDA in mid-July, Idec says. The BLA had a user fee action date of May 3
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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.’
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Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.
Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.