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Seven proposed 21st Century Cures Act bills sailed through the Senate HELP Committee on Wednesday, including one that would expand the priority review voucher program for rare pediatric diseases. Read More
Sponsors that fail to address all pediatric age groups or indications in their initial pediatric study plans would have 30 days to address any deficiencies and submit a new plan, FDA says. 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
The European Medicines Agency has launched its PRIority MEdicines initiative to accelerate breakthrough therapies that offer a major therapeutic advantage over existing treatments. Read More
Romozosumab met its primary endpoint by minimizing new vertebral fractures in postmenopausal women with osteoporosis through months 12 and 24. Read More