On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more
7/24/2025
/ Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements ,
Research and Development
With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close...more
Targeted protein degradation (TPD) is transforming drug discovery by leveraging the cell’s natural protein disposal systems to eliminate disease-causing proteins. Innovators are making rapid and successful advancements in the...more
In 1910, German scientist Paul Ehrlich introduced a groundbreaking concept to the world: chemical compounds could be engineered to interact with unique receptors on disease-causing cells while avoiding interaction with...more
4/9/2025
/ Acquisitions ,
FDA Approval ,
Innovation ,
Inter Partes Review (IPR) Proceeding ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more
2/13/2025
/ Artificial Intelligence ,
Compliance ,
Corporate Counsel ,
Data Integrity ,
Digital Health ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management