In November 2018, the Government Accountability Office (GAO) released a report titled “FDA Could Improve Designation Review Consistency; Rare Disease Drug Development Challenges Continue.” It follows up on the FDA’s Orphan…
Posts published in “Insights”
This article was originally published by Nigel S. Clarke in World Patent Information Volume 54, Supplement, September 2018, Pages S4-S10 under a Creative Commons license Abstract Some aspects of patent searching are…
This article was originally published by Hao Zhong, Ging Chan, Yuanjia Hu, Hao Hu and Defang Ouyang in Pharmaceutics 2018, 10(4), 263 under a Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). Abstract :…
This paper was originally published by Maxwell Robert Morgan, Owen Gwilym Roberts, and Aled Morgan Edwards in Wellcome Open Res 2018, 3:154 under a Creative Commons Attribution License Abstract M4K…
This is a guest post from Pepper Hamilton Partners John P. Isacson and N. Nicole Stakleff. John can be contacted at isacsonj@pepperlaw.com and Nicole can be contacted at stakleffn@pepperlaw.com. The Federal Circuit recently…
This article was originally published by Arun Kumar, Sandeep Kumar, and Arun Nanda in Adv Pharm Bull. 2018 Aug; 8(3): 355–363 under a Creative Commons License. Abstract Pharmaceutical Co-crystals are not new,…
Drug Repositioning: Concept, Classification, Methodology, and Importance in Rare/Orphans and Neglected Diseases
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This paper was originally published by Emanuel Almeida Moreira de Oliveira and Karen Luise Lang in Journal of Applied Pharmaceutical Science Vol. 8(08), pp 157-165, August, 2018 under the terms of the…
There is no simple way to explain drug prices, particularly in the US market, where drug prices vary considerably more than they do in other countries. Most Americans are familiar…
This article was originally published by Gerard T. Vondeling, Qi Cao, Maarten J. Postma, and Mark H. Rozenbaum in Applied Health Economics and Health Policy (2018) pp.1-8 under a Creative Commons Attribution-NonCommercial…
Former Congressman Henry Waxman was recently interviewed for the Clause 8 podcast about how he worked together with Sen. Orrin Hatch to pass the Hatch-Waxman Act and its aftermath. Congressman…