Why Generic Drug Makers May Benefit from 505(b)(2) Approval

A few years ago, there was much talk of the “patent cliff” facing blockbuster drugs like Lipitor and other huge name-brand drugs. The “patent cliff” may have spelled the end…
The post Why Generic Drug Makers May Benefit from 505(b)(2) Approval appeared…


Patenting human genes: Chinese academic articles’ portrayal of gene patents

This article was originally published by Li Du in BMC Medical Ethics 2018 19:29 under a creative commons license. Abstract Background The patenting of human genes has been the subject…
The post Patenting human genes: Chinese academic articles’ portraya…


The 505(b)(2) Drug Patent Approval Process: Uses and Potential Advantages

Drug development is one of the world’s most high-risk / high-reward industries, with the vast majority of drugs created never making it to market. Of those that do make it…
The post The 505(b)(2) Drug Patent Approval Process: Uses and Potential Advanta…


Pharmaceutical Portfolio Management Reading List

Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly…
The post Pharmaceutical Portfo…


How Artificial Intelligence Will Affect Healthcare and Drug Prices

Artificial intelligence (AI) is the development within computer systems of the ability to perform tasks that have traditionally required human intelligence. Examples of AI applications include visual perception, speech recognition,…
The post How Artifi…


Deep Learning in Drug Discovery and Medicine – Scratching the Surface

This paper was originally published by Dibyendu Dana, Satishkumar V. Gadhiya, Luce G. St. Surin, David Li, Farha Naaz, Quaisar Ali, Latha Paka, Michael A. Yamin, Mahesh Narayan, Itzhak D. Goldberg…
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Why Follow-On Pharmaceutical Innovations Should Be Eligible For Patent Protection

This article was originally published by Christopher M. Holman in Intellectual Property Watch under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License (http://creativecommons.org/licenses/by-nc-sa/4.0/). Despite the impor…


FDA Approval of New Drugs One of Many Goals for Drug Manufacturers

The US pharmaceutical market, together with those of Canada and Mexico, make more than half the global pharmaceutical. The US alone is the world’s largest and it represents 45 percent of…
The post FDA Approval of New Drugs One of Many Goals for Drug Ma…


Securing the Right Space for Your Biotech Start-up

This is a guest post by Steven Lee, Senior Scientist in the Life Sciences Group at Environmental Health & Engineering (EH&E) Once you have the idea and the funding for a biotech start-up, you may think the biggest challenges are behind you. However, without proper planning and considerations, the environment you choose for your laboratory facility […]


Demystifying Microbiome Probiotics (Supplements)

This is a guest post from Susan K Finston, President of Finston Consulting.  This is the latest entry in an occasional series tracking the microbiome.  I first wrote about the potential of the microbiome for human health in October 2015.  At that time there was little awareness of the significance and potential of the human microbiome.  […]


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