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MGI Dacogen Launch Plans Stress Efficacy Profile, Treatment Duration

Executive Summary

MGI will highlight the efficacy profile of its myelodysplastic syndromes therapy Dacogen when detailing decitabine to oncologists

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NME Slump Continues: FDA Clears 18 Novel Drugs In 2006, Same As 2005

FDA's final approval tally of new molecular entities in 2006 is almost a 25-year low, despite early signs that the agency was on pace to best last year's final count of NME approvals

Revlimid To Launch With Risk Management Plan; Restrictions Could Be Lifted

Celgene's Revlimid will launch under the risk management plan RevAssist to minimize fetal exposure, but the firm may lift the program if ongoing studies demonstrate there is no risk of teratogenicity

MGI Saforis NDA To Be Based On Single Phase III Trial; Filing Planned For Q3

MGI Pharma expects to file an NDA for Saforis (l-glutamine oral suspension) for the treatment of oral mucositis based on the results of one Phase III trial and supportive earlier-phase trials

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