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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

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Pink Sheet editor and reporters discuss the impact of Francis Collins’ departure as NIH director, whether FDA and CDC COVID-19 messaging should be harmonized, and the narrowing gap between standard and priority assessment costs.

Leadership Coronavirus COVID-19

NIH Director Collins’ Departure May Revive Patent March-In Debate

Confirmation hearing for successor will present opportunity to press the Biden administration on the patent march-in issue, but a policy change seems unlikely—unless the President feels a strong need to act on drug pricing in the absence of legislation.

Intellectual Property Pricing Debate

Pfizer Booster Dose Authorization From US FDA Has Age Caveat: At-Risk Populations 18 And Up

Age limit wasn’t part of advisory committee’s vote on third shot of the COVID vaccine, but aligns with concerns about myocarditis in younger recipients.

Coronavirus COVID-19 Vaccines

FDA Airs ‘Concerns’ Over IP Barriers

Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’

Intellectual Property Policy

US FDA’s Patent ‘Concerns’ Include Thickets, Product Hopping, And Evergreening

Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’

Intellectual Property Generic Drugs

Pink Sheet Podcast: Top US FDA Vaccine Leaders Retire, COVID-19 Booster Shots, JAK Inhibitor Safety

Pink Sheet reporters and editors consider the leadership shake-up at the FDA Office of Vaccines Research and Review, the COVID-19 vaccine booster shot debate, and the impact of new safety measures for several JAK inhibitors.

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