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M. Nielsen Hobbs

Executive Editor, US Regulatory & Policy

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

Pink Sheet Podcast: Medicare Inflation Rebates And Negotiation, Leqembi Reimbursement, US FDA Gene Therapy Chief

Pink Sheet reporter and editors discuss the first round of mandated Medicare inflation rebates and new guidance on price negotiations, consider the VA’s decision to cover the Alzheimer’s drug Leqembi, and the US FDA continuing to search for a cell and gene therapy office leader.

Pricing Debate Reimbursement

Leqembi’s FSS Pricing Meets ICER’s Cost-Effectiveness Threshold; VA Requiring Coverage With Evidence

Eisai/Biogen Alzheimer’s treatment isn’t actually on the VA formulary, but Leqembi’s Federal Supply Schedule price, coming in at just over $20,000 annually, could address spending concerns.

Government Payers Pricing Strategies

Leqembi Coverage By Veterans Affairs Department Sign Of Success For Eisai’s Payer Engagement Strategy

Alzheimer’s product is following a different playbook than Aduhlem, reflecting better data – and hard-earned lessons. Eisai estimates that 80-90% of veterans who are eligible for Leqembi treatment based on the FDA label would also fit the VA’s criteria.

Government Payers Medicare

Leqembi Coverage By Veterans Affairs Department Sign Of Success For Eisai’s Payer Engagement Strategy

Alzheimer’s product is following a different playbook than Aduhlem, reflecting better data – and hard-earned lessons. Eisai estimates that 80-90% of veterans who are eligible for Leqembi treatment based on the FDA label would also fit the VA’s criteria.

Government Payers Medicare

Pink Sheet Podcast: State Of The Generics Industry, US FDA Adcomm Reforms, EUAs Outside COVID-19

Pink Sheet reporters and editor discuss learnings from a generic drug industry trade association conference, as well as FDA Commissioner Robert Califf’s ideas for advisory committee changes and using emergency use authorizations in non-COVID-19 areas.

Generic Drugs Advisory Committees

With Video Testimonial Campaign, Generics Industry Aims To Not Be Taken ‘4GRxANTED’

AAM hopes everyday voices – and Mark Cuban’s – will help policymakers appreciate the contributions that generic drugs make to the healthcare system. ‘We need to create an emotional connection,’ a campaign designer said.

Generic Drugs Lobbying
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