M. Nielsen Hobbs
Interim Editor-in-Chief, Pink Sheet
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
Pink Sheet Podcast: BIOSECURE Act Advances, Trial Diversity Sticks, Platform Principles Without Designation
Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee, whether industry would improve clinical trial diversity with tougher enforcement of the regulation, as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program.
As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs
Pink Sheet infographic details the timeframes and potential extensions under the House version of the bill, which just cleared committee.
BIO Seeks ‘Substantial Runway’ To Shift Away From China As Momentum For Manfacturing Bill Grows
Association CEO John Crowley tells the Pink Sheet that a survey which found decoupling from China could be disruptive underscores the need to do so because having the supply chain ‘tied up with a global adversary is profoundly worrying to all of us.’
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.
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.
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.