Category: General Biotechnology

Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study

This article was originally published by Ravi Gupta, Thomas J Bollyky, Matthew Cohen, Joseph S Ross, and Aaron S Kesselheim  in BMJ 2018;360:k831 under a Creative Commons Attribution Non Commercial (CC BY-NC…
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3 Uses for Historical Versions of the FDA Orange Book

Officially known as Approved Drug Products With Therapeutic Equivalence Evaluations, the FDA Orange Book contains a list of drugs considered by the FDA as both effective and safe. It does…
The post 3 Uses for Historical Versions of the FDA Orange Book …


What We Know From 4-Plus Years of Drug Patent Challenges Heard by the PTAB

While the Patent Trial and Appeal Board invalidates Orange Book-listed patents less than 20 percent of the time, it accepts 66 percent of petitions from generic drugmakers and takes no…
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Patents for Combination Products: Challenges and Opportunities

Combination products offer companies new directions for drug patent innovation. Medicine has become more personalized over the past generation, and this has affected the drug patent system. One major trend…
The post Patents for Combination Produc…


Estimated costs of production and potential prices for the WHO Essential Medicines List

This article was originally published by Andrew M Hill, Melissa J Barber, and Dzintars Gotham in BMJ Global Health Jan 2018, 3 (1) e000571 under a Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license. Abstract Introduction There are persi…


Biobetters, Supergenerics Hold Many Advantages for Pharma Companies

By Larry Ramer, DrugPatentWatch writer A growing number of pharmaceutical companies are looking to simultaneously benefit from the low costs of developing generic treatments and the increased market share and…
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Biotech in Countries Starting with “I” – Part 12: Israel

This is a guest post from Susan K Finston, President of Finston Consulting.  A little over five years ago I penned the first installment in this irregular series, focused on Israel’s tech transfer prowess and efforts to encourage innovative life-sciences. I tracked the Start-Up Nation’s incremental progress here.    In a nutshell, Israel leveraged excellence in basic science and […]


Factors driving healthcare costs in the US

Health care costs in the US touched a staggering $3.2 trillion in 2015, which makes it one of the nation’s largest industries, equaling 17.8% of gross domestic product. This translates…
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Branded Generics Promise Profits for Drugmakers, Peace of Mind for Patients

Developing nations offer welcoming and growing markets as Abbott focuses exclusively on reformulating and marketing off-patent medications Driven by patient loyalty, prescriber preference, pharmacist trust, and traditional marketing, branded generics&#…


Formulary Decisions: Exploring the Ethics of Drug Approval

Formularies come into effect at the hospital level and the individual insurer level When developed and managed with due care and consideration, drug formularies can be a good tool for…
The post Formulary Decisions: Exploring the Ethics of Drug Ap…


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