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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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What’s The Key To Successful R&D With Artificial Intelligence? ‘Bilingual’ Scientists

Before J&J’s former chief data scientist Najat Khan moved to Recursion, she talked to the Pink Sheet about how AI is transforming trials and driving collaboration between industry and regulators.

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Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List

There are pending requests to add 13 candidates to the tropical diseases that qualify for a priority review voucher, according to a Pink Sheet analysis, as FDA Commissioner Robert Califf faces congressional pressure on the years since the list's last update.

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Pink Sheet Podcast: Relyvrio And Public Promises, Allergy Biomarker Adcomms, PMDA In The USA

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.

Post Market Regulation & Studies Advisory Committees

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.

Legal Issues Advisory Committees

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.

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