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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

Makena Will Get Extended Time On Market, Even If AMAG’s Appeal Fails

AMAG’s decision to fight US FDA’s decision to pull the preterm birth product seems unlikely to result in victory, but Makena will get to stay on the market during the appeal process, which is expected to be protracted and will likely include accusations that the agency is being insensitive to affected patients.

Review Pathway Gynecology & Urology

Pink Sheet Podcast: EUAs and Regulatory Changes After The Pandemic, Vaccines Adcom Prep

Pink Sheet reporters and editor discuss the future of coronavirus products with an emergency use authorization, potential pandemic-inspired regulatory changes at the FDA, and preview the agency’s upcoming advisory committee meeting on coronavirus vaccines.

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VP Debate: Pence Tries Vaccine Hesitancy Jujutsu On Harris

‘Senator, please stop undermining confidence in a vaccine,’ Pence says when confronted with the accusation that the administration is politicizing the COVID vaccine development effort.

Coronavirus COVID-19 Vaccines

'Like Water': Pharma Avoids Much Scrutiny In Messy Presidential Debate

Trump and Biden trade barbs in debate that included a suggestion by the president that coronavirus vaccine development delays are political and saw Biden questioned on whether he was contributing to vaccine hesitancy.

Elections Pricing Debate

Pink Sheet Podcast: US FDA Power Plays, Vaccine EUA Without The Sponsor, RBG’s Impact On Pharma

Pink Sheet reporter and editors examine the struggle over the FDA’s reputation, whether a coronavirus vaccine could be made available without sponsor cooperation, and the late Supreme Court Justice Ruth Bader Ginsburg’s legacy for pharma.

Coronavirus COVID-19 FDA

Playing The Trump Card On Rx Pricing

Obamacare repeal has been replaced by rebrand as Trump administration plans to use ACA’s Medicare demonstration powers to send discount cards to seniors, one of a slew of health care announcements that include Rx importation, pre-existing conditions, insulin and EpiPens.

Pricing Debate Elections
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