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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).

Latest From M. Nielsen Hobbs

Merck & Co Makes Case For Molnupiravir After Narrow FDA Nod

US regulators have granted emergency authorization to the antiviral molnupiravir but only for use when "alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate."

Approvals Coronavirus COVID-19

Merck’s Molnupiravir: Second COVID Pill Is Second-Line, But Timing Helps Both Sponsor And US FDA

After lengthy review, Merck’s antiviral gets very restricted indication as part of its EUA, apparently reflecting concerns over safety and efficacy. But molnupiravir does appear to have some advantages over Pfizer’s Paxlovid – including that more of it will be available in the short term.

Approvals Drug Approval Standards

Pink Sheet Podcast: Woodcock’s Legacy, Merck’s Oral COVID-19 Pill, 340B Case At Supreme Court

Pink Sheet reporters and editor review US FDA Acting Commissioner Janet Woodcock’s long career and update Robert Califf’s confirmation process, consider the advisory committee for Merck’s COVID-19 pill, and discuss an under-the-radar case on 340B policy at the US Supreme Court.

FDA Leadership

Operation Warp Speed: What The Logo Can Tell Us About Successful Pandemic Preparedness

Operation Warp Speed’s seal was a combination of ’70s design, au courant clip art, and 18th Century militarism, but just like the oddly assembled organization that it represented, the thing worked.

Coronavirus COVID-19 Innovation

Merck Molnupiravir Advisory Committee To Consider Pregnancy Risk, Viral Mutations

US FDA seems poised to authorize the oral COVID treatment, but panel discussion will likely highlight the limitations of the antiviral.

Advisory Committees Coronavirus COVID-19

Calculating Califf’s Course To Confirmation

Robert Califf got 89 votes in the Senate last time – but that’s also the least a Democratic nominee has ever gotten.

FDA Leadership
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