Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

US FDA’s COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved

Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.

Coronavirus COVID-19 Approvals

Pink Sheet Podcast: US FDA In A Biden Administration, Aducanumab’s Adcomm Failure

Pink Sheet reporters and editor discuss the potential changes at the FDA under President-elect Biden and the take-aways from the negative advisory committee recommendation for Biogen’s proposed Alzheimer’s drug aducanumab.

Coronavirus COVID-19 FDA

Bending, Not Breaking: HDA President Chip Davis On Rx Distribution During COVID

Rollout of a coronavirus vaccine offers chance to demonstrate distribution system’s value to policymakers, and Davis knows that could impact the trajectory of issues such as track and trace that will return to prominence after the pandemic eases.

Distribution Coronavirus COVID-19

Health Plan Disclosure Of ‘Negotiated’ And ‘Historical Net’ Drug Prices Required In HHS Rule

It’s not quite the rebate rule, but final reg aims for ‘a reduction in the use of rebates and other price concessions’ driven by the transparency requirement and broad definitions. PCMA warns that ‘mandating an increased level of disclosure for this information could result in higher prescription drug prices for consumers.’

Pharmacy Benefit Management Reimbursement

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.

Coronavirus COVID-19 Drug Review
See All
UsernamePublicRestriction

Register