Gardasil Faces Another Safety Study, Looking At Four Rare AEs
This article was originally published in The Pink Sheet Daily
Executive Summary
Sentinel will consider data from 3m doses of Merck's nine-valent HPV vaccine.
You may also be interested in...
Merck’s Gardasil Adds Serotypes; Boosting Vaccinations Seems Bigger Challenge
Promotion strategy likely to remain same after nine-valent HPV vaccine wins FDA approval; Merck may need help from the CDC to overcome cultural barriers to adoption.
Cervarix Gets One Up On Gardasil In Cross-Protection: HPV-31 In FDA Approval
GlaxoSmithKline's effort to make its bivalent human papillomavirus vaccine, Cervarix, into a multivalent product through proof of cross protection against additional HPV virus strains achieved a partial, one-virus, success at FDA
Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?
EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.