Category: General Biotechnology

The US Food and Drug Administration’s tentative approval process and the global fight against HIV

This paper was originally published by Harinder Singh Chahal, Jeffrey S Murray, Martin Shimer, Peter Capella, Ryan Presto, Mary Lou Valdez, and Peter G Lurie in Journal of the International AIDS…
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Improve Your Litigation Success, Predict Settlement Terms, and Write Better Patents by Analyzing Patent Challenges

Litigation related to drug patents, whether it be direct patent challenges, contract disputes, or other cases, can provide direct intelligence (through disclosures of competitive intelligence) or indirect intelligence through exposure…
The post Improve…


How Pharmacists Are Trapped in the Middle of Drug Price Wars

Pharmacists, as the interface between the general public and prescription drug manufacturers, can sometimes feel as if they’re treading a fine line between fulfilling their obligations to pharmaceutical companies and…
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Generic Drug Launch Dates – A 1-step Solution to Navigate the Web of Drug Patents and Regulatory Protections

Drugs can have many patents and regulatory protections Drugs can be covered by myriad patents and regulatory protections. Even Aspirin, which was first invented in 1853, has new patents. For…
The post Generic Drug Launch Dates – A 1-step Solution to Na…


Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment

This is paper was originally published in BioMed Research International, Volume 2016, by Tomas Gabriel Bas and Carolina Oliu Castillo under a Creative Commons Attribution License Abstract The development of…
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China and Potential Opportunity for Pharmaceutical Investments

Although many areas of contention exist in trade relations between the United States and China, ties are strengthening between the two countries, particularly in the areas of science and technology.…
The post China and Potential Opportunity for Pharmac…


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…
The post Affordability and availability of …


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…
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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…
The post What We Know From 4-Plus Years of Drug Patent Chall…


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…


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