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.’
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
