Publications by authors named "Michael Lanthier"

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Measuring the First Mover Advantage in US Biosimilar Markets.
J Daniel McGeeney, Aylin Sertkaya, Samantha A McCormick, Andreas Lord, Ayesha Berlind, Michael L Lanthier

Value Health· December 2025

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Orphan Drug Label Expansions: Analysis Of Subsequent Rare And Common Indication Approvals.
Kathleen L Miller, Michael Lanthier

Health Aff (Millwood)· January 2024

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An Analysis of Antibacterial Drug Development Trends in the United States, 1980-2019.
Nidhi Dheman, Nicole Mahoney, Edward M Cox, John J Farley, Thushi Amini, Michael L Lanthier

Clin Infect Dis· December 2021

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An Analysis of Follow-On Development in New Drug Classes, January 1986-June 2018.
Michael L Lanthier, Kirk W Kerr, Kathleen L Miller

Clin Pharmacol Ther· November 2019

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Investigating the landscape of US orphan product approvals.
Kathleen L Miller, Michael Lanthier

Orphanet J Rare Dis· October 2018

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Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.
Andreas Schick, Kathleen L Miller, Michael Lanthier, Gerald Dal Pan, Clark Nardinelli

Drug Saf· June 2017

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Trends In Orphan New Molecular Entities, 1983-2014: Half Were First In Class, And Rare Cancers Were The Most Frequent Target.
Kathleen L Miller, Michael Lanthier

Health Aff (Millwood)· March 2016

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Regulatory watch: What drives differences in review times among CDER divisions?
Andreas Schick, Kathleen L Miller, Michael Lanthier, Janet Woodcock

Nat Rev Drug Discov· October 2015

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Regulatory watch: Innovation in biologic new molecular entities: 1986-2014.
Kathleen L Miller, Michael Lanthier

Nat Rev Drug Discov· February 2015

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Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.
Leonard V Sacks, Hala H Shamsuddin, Yuliya I Yasinskaya, Khaled Bouri, Michael L Lanthier

JAMA· January 2014

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An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011.
Michael Lanthier, Kathleen L Miller, Clark Nardinelli, Janet Woodcock

Health Aff (Millwood)· August 2013

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Accelerated approval and oncology drug development timelines.
Michael L Lanthier, Rajeshwari Sridhara, John R Johnson, Ann Farrell, Patricia Keegan

J Clin Oncol· May 2010

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Economic issues with follow-on protein products.
Michael Lanthier, Rachel Behrman, Clark Nardinelli

Nat Rev Drug Discov· September 2008

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Drug-review deadlines and safety problems.
Clark Nardinelli, Michael Lanthier, Robert Temple

N Engl J Med· July 2008

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