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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: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings

Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.

Legislation Manufacturing

Trimming The Tree: What’s In The PDUFA Legislative Package – And What’s Out

The must-pass bill has many FDA policy ornaments hanging from it, but the version released by Democratic and Republican committee leadership has notable absences as well, including Cures 2.0.

User Fees Legislation

Pink Sheet Podcast: Young Children’s COVID Vaccines, Aduhelm Coverage Criticism, McKinsey Conflicts

Pink Sheet reporter and editor discuss next steps in the development of COVID-19 vaccines for young children, complaints about CMS’s coverage decision for Aduhelm, and the congressional investigation of McKinsey’s FDA conflicts of interest.

Coronavirus COVID-19 Medicare

Back To Normal-ish: What To Expect As Pharma Resumes In-Person Gatherings

With the mask mandate now lifted for air travel and the grimmer milestone of one million Americans dead from COVID approaching, the Pink Sheet looks back at the generic trade association’s annual meeting to see what business gatherings may look like going forward.

Generic Drugs Coronavirus COVID-19

Medicare Premiums and Aduhelm: The Political Headache Continues

CMS took pains in its final national coverage determination to try to mend fences with FDA; how the NCD will play with Medicare recipients remains an open question, especially since the Alzheimer’s-induced premium hikes remain in effect.

Medicare Politics

Pink Sheet Podcast: Aduhelm Coverage Campaign, Rx Pricing Reform Future, COVID Impact At US FDA

Pink Sheet reporter and editors discuss a grassroots campaign against coverage of a controversial Alzheimer’s treatment, the potential for drug pricing reform, and the pandemic effects on FDA hiring and retention.

Pricing Debate Coronavirus COVID-19
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