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M. Nielsen Hobbs

Interim Editor-in-Chief, Pink Sheet

Washington, DC

Nielsen has been covering the pharmaceutical industry most of his life, reporting on everything from ANDAs to Zika vaccines. He strongly believes that the user fee system needs to stop using Roman numerals. His favorite stories are ones that help readers understand the personalities and policies that dictate whether their regulatory strategy succeeds or fails. A regular contributor to the Pink Sheet podcast, he also creates infographics and editorial feature images for articles. Before joining Pink Sheet he worked for Congressional Quarterly. Nielsen frequently moderates webinars and panels at industry conferences, and enjoys discussing R2-D2 almost as much as he enjoys talking about 351(k).

Latest From M. Nielsen Hobbs

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Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed, an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees, and Japan’s PMDA opening an office in Washington D.C.

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Pink Sheet Podcast: Mifepristone And Misinformation At SCOTUS, Understanding US FDA’s ODAC

Pink Sheet reporters and editor discuss the upcoming US Supreme Court arguments on mifepristone access, the SCOTUS reaction to the fight against misinformation, and the FDA’s Oncologic Drugs Advisory Committee going against three negative product reviews.

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AstraZeneca Joins The $35 Inhaler Club; Medicare Patients Waiting On Congress For Membership

AZ’s move follows Boehringer’s announcement earlier this month and parallels what insulin sponsors did – but almost in reverse. For inhalers, political pressure on out-of-pocket costs has produced copay caps in the commercial market first, not Medicare.

Pricing Debate Medicare

Pink Sheet Podcast: Vanda Takes Jet Lag Denial To Court, Mark Cuban vs. PBMs, Austere FDA Budget

Pink Sheet reporters and editor discuss Vanda’s decision to sue the FDA over the rejection of the Hetlioz jet lag indication, Mark Cuban’s comments at a White House event that the federal government and others should stop doing business with the big three PBMs, and the cut in non-user fee dollars in the FY 2024 FDA appropriations bill.

Legal Issues Pricing Debate

FDA Still Soliciting Applications For START Pilot As Deadline For Rare Disease Program Looms

Agency anticipated receiving more applications for the program, which aims to bring Operation Warp Speed-like response to investigational rare disease therapies, than it has so far, though a last-minute ‘flood’ is still expected. CBER and CDER are accepting requests through 1 March.

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Immortalizing Janet Woodcock

Offering a regulatory Mt. Rushmore to place the outgoing principal deputy commissioner in historical context.

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