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Participation in biosimilar development program activities with the FDA has seen a steady uptick over the past three fiscal years — from 33 in fiscal 2013, to 57 last year — according to an analysis by independent consulting firm Eastern Research Group. Read More
The average cost of developing a new drug continues to rise, even as approval success rates continue to fall, according to a report that pegs the cost of ushering a candidate through FDA approval at an eye-popping $2.6 billion. Read More
The European Medicines Agency has launched an investigation into Gilead Sciences’ cancer drug Zydelig following an increase in serious adverse events. Read More
Celldex Therapeutics has pulled the plug on a Phase 3 trial of immunotherapy Rintega in patients with EGFRvIII-positive glioblastoma after a mid-trial analysis showed the candidate fared worse than a control group. Read More