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M. Nielsen Hobbs

Executive Editor

Washington DC
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

US FDA To Withdraw Pain Drug Guidance As Part Of Response To Opioid Epidemic

"At least four" guidances will replace it, Commissioner Gottlieb notes in frank update which states "I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis."
Drug Safety FDA

Real-World Evidence Could Help Relax Clinical Trial Enrollment Criteria

FOCR study suggests overall survival for PD-1s seen in real-world datasets is similar to results from clinical trials.

Cancer Drug Approval Standards

Biosimilars: US FDA Expecting More Applications, Fewer Applicants

Preparing biosimilar applications still takes as much time as it would for an original BLA, FDA says.
Biosimilars Drug Review

Decline In Civil Discourse Harms US FDA's Operations, Woodcock Says

'Polarization of opinions has always been a problem for us and has only been heightened,' CDER chief tells DIA.

FDA Drug Approval Standards

Trump Expecting Rx Price Reduction Announcements In Two Weeks

Look for Administration to take credit for any positive pricing news as President says several firms will 'announce voluntary massive drops in prices.'

Pricing Debate Legislation

How Drug Promotion Might Change Under Trump's Rx Pricing Plan

DTC disclosure requirements are shiny but probably not substantive; copay navigator might be weightier.

Pricing Debate Advertising, Marketing & Sales
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