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M. Nielsen Hobbs

Executive Editor

Washington DC
M. Nielsen Hobbs has more than 20 years of experience covering the pharmaceutical industry, and writes frequently about the intersection of business, regulation, science and politics. Before joining the “The Pink Sheet” he worked for Congressional Quarterly. Hobbs enjoys discussing BB-8 almost as much as he enjoys talking about 351(k).

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.

Coronavirus COVID-19 Vaccines

Pink Sheet Podcast: COVID-19 Vaccine Trial Stopped, Sponsor Filing Pledge, Rare Voucher Extended

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.

Coronavirus COVID-19 Vaccines

Pink Sheet Podcast: COVID-19 Vaccine Distribution Plan And Approval Concerns, Gene Therapy Coaching

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.

Coronavirus COVID-19 Vaccines

J&J’s COVID Vaccine Contract With US Bucks Trend Of Increasingly Lucrative Deals

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.

Vaccines Reimbursement

AstraZeneca, Janssen, Novavax Likely To Be Next ‘Warp Speed’ Vaccines In Phase III

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.

Vaccines Coronavirus COVID-19

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.

Coronavirus COVID-19 Rare Diseases
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