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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

Gottlieb’s Rx For Coronavirus

Study everything together and a scale-up manufacturing after preliminary efficacy results, former FDA commissioners Gottlieb and McClellan and their coauthors recommend in a pair of white papers on how the US should respond to the coronavirus pandemic.

Coronavirus COVID-19 Clinical Trials

Pink Sheet Podcast: Understanding the White House Coronavirus Treatment Announcement, US FDA Postpones Domestic Inspections, Biologics Transition Day Arrives

Pink Sheet editor and reporters discuss the pending trials of chloroquine for use against coronavirus, expanded access for remdesivir, and the official move of several biologics from regulation as drugs to regulation as biologics. 

Coronavirus COVID-19 Biologics

Pink Sheet Podcast: US FDA Announces Coronavirus Containment Strategy, Issues Updated Type 2 Diabetes Guidance

Pink Sheet reporter and editor consider the fall-out from the FDA decision to cancel meetings and postpone inspections due to the coronavirus pandemic, as well as look at the new cardiovascular recommendations for Type 2 diabetes drug development.

Coronavirus COVID-19 Clinical Trials

Medicare’s Insulin Demo Project Likely Depends On Plan Interest

Manufacturers are on board for ‘Part D Senior Savings Model’ that would set a $35 copay cap, but added risk corridor payments may be the key to getting PBMs to offer the enhanced plans focused on reducing insulin costs for patients.

Pricing Debate Medicare

Pink Sheet Podcast: Affordability And The US Coronavirus Response, Biologics Transition Guidance May Force Strategy Changes

Pink Sheet reporter and editor consider congressional demands that government-funded coronavirus research produce affordable medicines and vaccines, as well as the one-word change to the biologics transition guidance that may affect the availability of authorized biosimilars.

Infectious Diseases Biosimilars

Sandoz Deal In Price-Fixing Case Is Largest Ever For Domestic Antitrust Case

$195m deferred prosecution agreement with the US DOJ could be followed by civil settlement that's almost as large, illustrating the strong evidence in the generic price-fixing investigation thus far.

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