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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