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…
The post Key Findings from G…
Key Findings from GAO Report on Orphan Drug Approval Modernization Read Post »
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…
The post The basics of patent searc…
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 :…
The po…
A Comprehensive Map of FDA-Approved Pharmaceutical Products Read Post »
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…
The post Ideation and implementation of an open scien…
This is a guest post from Pepper Hamilton Partners John P. Isacson and N. Nicole Stakleff. John can be contacted at [email protected] and Nicole can be contacted at [email protected]. The Federal Circuit recently…
The post Obviousness-Type D…
Obviousness-Type Double Patenting Just Became Less of a Problem for Innovators Read Post »
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,…
The post A Review about Regulatory Status …
A Review about Regulatory Status and Recent Patents of Pharmaceutical Co-Crystals Read Post »
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…
The post Drug Repositioning: Concept, Classificati…
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…
The post PBMs, Formularies, and Rebates: What Investors Should Know app…
PBMs, Formularies, and Rebates: What Investors Should Know Read Post »
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…
The post The Impact of Patent…
The Impact of Patent Expiry on Drug Prices: A Systematic Literature Review Read Post »
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…
The post Clause 8 Podcast Interview with Co-Author of the…
Clause 8 Podcast Interview with Co-Author of the Hatch-Waxman Act Read Post »