Pink Sheet’s Top Seven Infographics Of 2022
From US drug pricing to Japan’s Sakigake expedited pathway, important regulatory developments and trends are easier to understand and track with Pink Sheet graphics.
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Nicardipine-Releasing Brain Implant Secures EMA PRIME Designation
Promising safety, tolerability and efficacy data for the NicaPlant implant formed the basis of the BIT Pharma’s application for a place on the European Medicines Agency’s priority medicines scheme.
US FDA Begins Implementing New User Fee Programs, But What About The Actual Fees?
Sponsors looking to file applications continue to wait for the new user fees to be announced, as details of the Split Real-Time Application Review (STAR) program, generic drug facility inspection readiness requirement and other changes are revealed.
PRIME Dry Spell Over As EMA Says Yes To Pfizer & BioCryst
This year’s first designations under the European Medicines Agency’s priority medicines scheme have gone to a maternal vaccine for an infection in newborns and a treatment for an ultra-rare bone disorder.