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M. Nielsen Hobbs

M. Nielsen Hobbs has more than 20 years of experience covering the pharmaceutical industry, and writes frequently about the intersection of business, regulation, science and politics. Before joining the “The Pink Sheet” he worked for Congressional Quarterly. Hobbs enjoys discussing BB-8 almost as much as he enjoys talking about 351(k).
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Latest From M. Nielsen Hobbs

The Drug Pricing Summit Pharma Wasn't Invited To

Does the Trump-Cummings confab mean that drug makers are doomed to price negotiations in Medicare Part D? (Answer: Almost certainly not, but this is Trump we're talking about.)

Pricing Debate Medicare

Biosimilars Could Face 'Litigation Backlog' Without Patent Reforms, AAM Fears

Category is still in its infancy, but the newly renamed generic association worries that products might never reach their full potential if launches are substantially delayed by IP disputes.

Biosimilars Intellectual Property

GPhA Rebrands As AAM, Hopes To Change Tenor Of Drug Pricing Debate

How is the generic industry like Captain "Sully" trying to land a damaged plane in the Hudson River?


Trump’s Rx For The Drug Industry: Take Two And Have No Idea What Will Happen In The Morning

To call the incoming US president unpredictable would be an understatement, but that doesn’t mean that industry shouldn’t know what to expect.

US Election 2016 Policy & Regulation

21st Century Cures Revisions Tell FDA To Highlight ‘Patient Experience Data’

Lame-duck passage is goal of changes to reform legislation, which now includes highly targeted funding for FDA.

Legislation Generic Drugs

Trump’s FDA Reform Agenda: Patient-Focused Approvals

A posting on the transition website takes a much milder tone than the GOP platform issued over the summer.

US Election 2016 Drug Review
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