Why hasn't there been more progress in new Chagas disease drug discovery?
AB Vermelho, GC Rodrigues… - Expert Opinion on Drug …, 2020 - Taylor & Francis
Introduction: Chagas disease (CD) is a neglected disease caused by the protozoan parasite
Trypanosoma cruzi. In terms of novel drug discovery, there has been no progress since the …
Trypanosoma cruzi. In terms of novel drug discovery, there has been no progress since the …
The United States Food and Drug Administration (FDA) regulatory response to combat neglected tropical diseases (NTDs): A review
S Mukherjee - PLOS Neglected Tropical Diseases, 2023 - journals.plos.org
The availability and accessibility of safe and effective drugs, vaccines, and diagnostics are
essential to reducing the immense global burden of neglected tropical diseases (NTDs) …
essential to reducing the immense global burden of neglected tropical diseases (NTDs) …
Using four decades of FDA orphan drug designations to describe trends in rare disease drug development: substantial growth seen in development of drugs for rare …
KL Miller, LJ Fermaglich, J Maynard - Orphanet journal of rare diseases, 2021 - Springer
Background Orphan drug designations are a useful proxy to investigate trends in rare
disease drug development. Drug developers must receive a designation before they are …
disease drug development. Drug developers must receive a designation before they are …
'Benevolent'patent extensions could raise billions for R&D in poorer countries
CB Barrett - Nature, 2023 - nature.com
Research into vaccines, crop seeds and other innovations for low-or middle-income nations
could be rewarded by offering longer patent coverage for profitable, non-essential …
could be rewarded by offering longer patent coverage for profitable, non-essential …
The impact of the priority review voucher on research and development for tropical diseases
Background In 2007, the priority review voucher (PRV) was implemented in the US to
incentivize research and development (R&D) for tropical diseases. The PRV is issued by the …
incentivize research and development (R&D) for tropical diseases. The PRV is issued by the …
Impact of the priority review voucher program on drug development for rare pediatric diseases
TJ Hwang, FT Bourgeois, JM Franklin… - Health Affairs, 2019 - healthaffairs.org
Only an estimated 5 percent of rare pediatric diseases have a treatment, although
collectively they affect more than ten million children in the US. To stimulate drug …
collectively they affect more than ten million children in the US. To stimulate drug …
US Tropical Disease Priority Review Vouchers: Lessons In Promoting Drug Development And Access: Article examines infectious disease drug and vaccine …
DB Ridley, P Ganapathy, HE Kettler - Health Affairs, 2021 - healthaffairs.org
The COVID-19 global pandemic has devastated lives and economies. It has served as a
reminder of how critical it is to invest in preventing and treating infectious diseases. Until the …
reminder of how critical it is to invest in preventing and treating infectious diseases. Until the …
Understanding the rewards of successful drug development—thinking inside the box
D Khullar, JA Ohn, M Trusheim… - New England Journal of …, 2020 - Mass Medical Soc
Rewards of Successful Drug Development Risks and rewards change during the life cycle of
a drug. In the innovation period, drug companies invest in developing new products but …
a drug. In the innovation period, drug companies invest in developing new products but …
Association between expedited review designations and the US or global burden of disease for drugs approved by the US Food and Drug Administration, 2010–2019 …
MJ Jackson, G Vaughan, FD Ledley - BMJ open, 2024 - bmjopen.bmj.com
Objectives Pharmaceutical innovation can contribute to reducing the burden of disease in
human populations. This research asks whether products approved by the US Food and …
human populations. This research asks whether products approved by the US Food and …
Clinical Benefit and Revenues of Drugs Affected by Rare Pediatric Disease Priority Review Vouchers, 2017-2023
ITT Liu, AS Kesselheim - The Journal of Pediatrics, 2024 - Elsevier
Objective To determine the clinical benefit of drugs that earned or redeemed rare pediatric
disease priority review vouchers (PRVs) from 2017 through 2023, and the revenues …
disease priority review vouchers (PRVs) from 2017 through 2023, and the revenues …