M. Nielsen Hobbs
Latest From M. Nielsen Hobbs
Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents
Pink Sheet reporters and editor discuss the pandemic’s effects on non-coronavirus-related product manufacturing, US FDA efforts to ensure vaccine sponsors maintain placebo controls once a product is available, and precedents that burden the agency.
Pink Sheet reporters and editor discuss the ramifications of the AstraZeneca vaccine trial hold and vaccine sponsors pledging to wait until the completion of Phase III before submitting applications, as well as efforts to extend the rare pediatric disease priority review voucher program.
Pink Sheet reporters and editor discuss coronavirus vaccine allocation and prioritization proposals, sponsors submitting before Phase III is completed, and a CBER proposal to create a coaching staff for inexperienced gene therapy sponsors.
Estimated $14 price per dose for Janssen’s investigational vaccine is first drop in value since Operation Warp Speed started signing contracts. The $1bn purchase order for 100 million doses and earlier $456m for development work is considerably less lucrative than the $2.1bn deal with GSK/Sanofi announced last week, especially since Janssen’s product may end up being a one-dose regimen.
While AstraZeneca’s adenovirus candidate is expected to use Operation Warp Speed’s platform, its start date remains cloaked; the Janssen and Novavax candidates are expected to enter Phase III in September and October, respectively.
Pink Sheet Podcast: Coronavirus Vaccines Move Into Phase III, US FDA Coronavirus Workload Changes, Rare Pediatric Priority Review Voucher Expiration
Pink Sheet reporters and editor discuss the start of Phase III coronavirus vaccine trials, FDA’s pandemic work is transitioning away from the idea stage, and the push for a permanent extension of the rare pediatric disease priority review voucher program.