Newsletter | February 3, 2025

02.03.25 -- Court Ruling Alters The Calculus For Orange Book Patent Listings

FEATURED ARTICLE

Court Ruling Alters The Calculus For Orange Book Patent Listings

Recent court rulings have changed the way branded and generic drug manufacturers should think about patent listings in the FDA Orange Book. Hatch-Waxman experts at Polsinelli detail the changes and implications, and make predictions about what comes next.

INDUSTRY INSIGHTS

Transforming Clinical Trial Disclosure With AI

Unlock the full potential of AI to address sponsor challenges including regulatory complexity, clinical trial disclosure requirements, and growing demands for transparency.

From Manual To Automated: Navigating Financial Waters In Clinical Trials

Managing finances during clinical trials is often as critical as the trials themselves. Learn the benefits of transitioning from manual to automated financial processes for more efficient trials.

Rapid, Automated, At-Line Adenovirus Quantitation

Gain insight into how a high-throughput capsid assay for rapid AV quantification was developed using an innovative Bio-Layer Interferometry (BLI) platform that offers high precision and reliability.

Ophthalmic Drug Delivery

Explore the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.

Harnessing Analytical Development To Empower Process Development

This presentation addresses the critical need for high-throughput, reliable analytical development strategies to support expedited Investigational New Drug (IND) applications.