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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Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry
Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.
Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.
Employers and other health plan sponsors may need to push for better targeted reforms that lower cost sharing for patients.