GLP-1 receptor agonists (GLP-1RAs) were initially approved for diabetes treatment (e.g., Ozempic®) but have revolutionized weight management (e.g., Wegovy®) and are now being explored for treating a wide range of health...more
Artificial intelligence (AI) has transformed scientific research and innovation, yet as previously discussed, the Polanyi Paradox remains a significant obstacle to using AI to generate creative solutions or breakthrough...more
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
1/16/2025
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Clinical Trials ,
Compliance ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Machine Learning ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements ,
Risk Management ,
Trade Secrets
What Are ADCs and Why Are They Growing?
Over the past few years economic headwinds have resulted in fewer deals, with companies and private equity firms alike reassessing where to spend money. But one portion of the...more
Antibody-drug conjugate (ADC) is a promising class of cancer treatments with accelerating U.S. Food and Drug Administration (FDA) approval and rapidly growing market size as discussed in previous articles in this series. This...more
The use of artificial intelligence (AI) to advance stem cell therapy has produced exciting results, with a key role in driving recent growth and innovation. Separated into three parts, this article provides an overview the...more
10/24/2023
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Artificial Intelligence ,
Biotechnology ,
Innovation ,
Intellectual Property Protection ,
Inventions ,
Patent Act ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
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Stem cells
The rapid development of artificial intelligence (AI) systems will significantly impact businesses that rely on genomic data analysis for research and development of therapeutics and diagnostic decision-making. This article...more
A major step forward in using Artificial Intelligence (AI) for scientific discovery in the field of stem cell research was recently reported, reflecting the continued growth of the technology and stressing the need for...more
The Federal Circuit decision in Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. addressed several aspects of obviousness doctrine. We previously wrote about the impact of a blocking patent on consideration of objective...more
In a non-precedential decision issued in In re Bhagat, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that claims directed to certain lipid compositions were ineligible for...more