M. Nielsen Hobbs
Executive Editor, US Regulatory & Policy
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
Infographic: One of the more prominent arguments against the Medicare drug price negotiation program is that by limiting the number of years that products can be marketed before price caps are imposed, the scheme discourages development of additional indications.
Pink Sheet Podcast: CMS Listens On Price Negotiations, Elevidys Top-Line Trial Data, Gene Therapy Reg Changes
Pink Sheet reporters and editor discuss take-aways from the first Medicare price negotiation program public listening sessions, next steps after Sarepta reported questionable top-line data for its Duchenne muscular dystrophy gene therapy Elevidys, and indications the FDA may adjust its regulatory approach to gene editing products.
Pink Sheet Podcast: US FDA Suffers From Shutdown Threat, Alnylam’s CR Letter, ARPA-H Wants FDA Incentives
Pink Sheet reporters and editor discuss the problems that emerged for the US FDA from just the threat of a government shutdown, take-aways on the FDA advisory committee process based on the complete response letter issued for Alnylam’s Onpattro, and incentives that the FDA could offer for ARPA-H projects that reach the application stage.
Pink Sheet Podcast: Regeneron’s COVID Monoclonal Deal, New FDA Advisor, Project Optimus In Cancer Combos
Pink Sheet reporter and editors discuss the somewhat novel pricing language in Regeneron’s deal with the US government to develop a COVID-19 monoclonal antibody, US FDA Commissioner Robert Califf hiring a new senior advisor, and optimizing dosing in cancer combination therapies.
Abbvie, Amgen, Novartis and Novo Nordisk have drugs on the list but haven’t sued yet. While they could add to the ranks of legal opposition, the Court Battle for the IRA is more about philosophy than numbers.
Advertising Untitled Letter For Exeltis Slynd Social Media Spot Renews Attention To Online Risk Disclosure
Oral contraceptive’s ad did not contain any risk information and was not submitted to US FDA beforehand, so the letter seems an easy call. But with two citations released in as many weeks, is the agency signaling an uptick in enforcement?