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The FDA’s plans to create a pilot database of clinical outcome assessments lacks the depth and breadth of data needed to make it worthwhile, according to comments from industry and advocacy groups. Read More
The European Medicines Agency and the FDA are launching investigations into Gilead Sciences’ cancer drug Zydelig following an increased rate of serious adverse events, including deaths. 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
As it bolsters efforts to tackle the growing opioid epidemic, the FDA last month outlined what tests sponsors of abuse-deterrent generic opioids should submit. Read More
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
With the completion of the Senate HELP Committee’s third and final markup on biomedical innovation legislation, a complete cures package is expected to hit the full Senate shortly. Read More