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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: New Drug Submissions Lag, More US FDA Emergency Use Authorizations On The Way, BsUFA Revenue Misses Estimates

Pink Sheet reporter and editors discuss the lower application submission rate, another EUA for a potential coronavirus treatment, and the biosimilar user fee program missing revenue estimates again.

Coronavirus COVID-19 Drug Review

Pink Sheet Podcast: Coronavirus Vaccine Selection Depends On Manufacturing, Hydroxychloroquine EUA Is Revoked, Rare Pediatric Disease Voucher Program In Danger

Pink Sheet reporter and editor discuss Operation Warp Speed’s vaccine manufacturing goals, the US FDA’s decision to pull the hydroxychloroquine emergency use authorization, and the race to beat the eligibility deadline for a rare pediatric disease priority review voucher.

Coronavirus COVID-19 Vaccines

Pink Sheet Podcast: Merck’s Frazier Speaks Out, US FDA’s Hahn On Decisions, Operation Warp Speed, Worries About User Fee Goal Delays

Pink Sheet reporters and editor discuss Merck CEO Ken Frazier’s thoughts on racial inequity, FDA Commissioner’s explanation of coronavirus decision-making and Operation Warp Speed changes, and consider fears about the potential for user fee goal delays.

Coronavirus COVID-19 Leadership

Merck’s Frazier Urges Businesses To Use ‘Every Instrument At Their Disposal’ To Reduce Racial Inequity

‘What we have to guard against is that when the streets quiet down … a lot of people are going to go back to their normal lives,’ Merck CEO Ken Frazier says in an interview with CNBC.

Leadership United States

Merck’s Frazier Urges Businesses To Use ‘Every Instrument At Their Disposal’ To Reduce Racial Inequity

‘What we have to guard against is that when the streets quiet down … a lot of people are going to go back to their normal lives,’ Merck CEO Ken Frazier says in an interview with CNBC.

Leadership United States

PDUFA Renewal Negotiations: What Does Industry Want Now?

With the formal, virtual kick-off meeting set for 23 July, US FDA and sponsors are looking at a transformed landscape as they discuss what the next five years of user fees will look like.

User Fees Drug Review
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