Brakes On Sanofi’s Dengvaxia Prospects Amid WHO-SAGE Screening Advice?
Executive Summary
WHO’s recommendation around a pre-vaccination screening strategy for Sanofi’s Dengvaxia could potentially dull the prospects of the product further, especially in emerging markets with stretched healthcare resources. One industry expert suggests that governments should probably consider introducing the vaccine only after “better tests and tools” become available.
You may also be interested in...
Sanofi's Dengvaxia Postmarket Monitoring Plan Targets Vaccine's Safety Concerns
Company proposes enhanced real-world monitoring to identify dengue vaccine’s risks, including severe and hospitalized dengue in individuals not previously infected, US FDA says in briefing document for March 7 advisory committee meeting.
US FDA’s Biologics Center Faces Exciting 2019 After Quiet Year For Novel Approvals
CBER’s novel biologic approvals in 2018 were few, long, and with a low level of innovation. But the center’s work to build regulatory framework for emerging technologies is setting the stage for a different story in 2019.
Keeping Track: FDA Starts November With A Bang
The latest drug development news and highlights from our FDA Performance Tracker.