FDA Accelerates Clinical Trials with Real-Time Data, Pfizer Extends Vyndamax Patent Until 2031

The U.S. Food and Drug Administration (FDA) is taking steps to enhance the efficiency of clinical trials by reviewing data in real time from trials conducted by AstraZeneca and Amgen. The agency has also invited public input on a potential pilot program to collaborate with companies leveraging artificial intelligence (AI) for safety monitoring, dose optimization, signal identification, and patient recruitment in clinical trials.

The trials will utilize a real-time data platform developed by Paradigm Health, aiming to reduce the time regulators and companies spend exchanging data. FDA Commissioner Marty Makary stated at a press conference that agency reviewers will be able to access safety signals and clinical endpoints through Paradigm’s platform.

Pfizer Settles Patent Disputes, Extends Vyndamax Protection Until 2031

Pfizer has reached settlements with three generic drugmakers—Dexcel Pharma, Hikma Pharmaceuticals, and Cipla—over patent disputes related to its blockbuster heart drug Vyndamax. These agreements effectively extend the drug’s patent protection in the U.S. until June 1, 2031, delaying the entry of cheaper generic alternatives into the market.

The settlements resolve patent infringement lawsuits filed in the Delaware federal court. A trial over the patent had commenced this week. Vyndamax, an oral medication used to treat transthyretin amyloid cardiomyopathy, a serious heart condition, generated nearly $6.4 billion in sales for Pfizer in 2025.

The settlements extend U.S. patent protection for Vyndamax until June 1, 2031, subject to other pending litigation. Previously, Pfizer anticipated a significant drop in U.S. revenue for the drug in 2029, but the company now expects sales to remain relatively stable from 2028 through mid-2031.