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With only 2 percent to 7 percent of adult cancer patients participating in clinical trials, social media may provide a boost to enrollment with targeted messages to connect patients, caregivers and families with potential trial enrollment websites, according to a study in JAMA Oncology. 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
After a French Phase 1 clinical trial in January designed by Portuguese drugmaker Bial Laboratories left one patient dead and another six hospitalized, an Agency for Medicines and Health Products Safety-appointed committee determined that an “off-target effect” of the compound is a probable explanation of the tragedy. Read More
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