Biopharma new product strategic launch sequencing (SLS) is becoming increasingly more controversial and complex. In the first part of this article on biopharma new product SLS, we review the background and significant challenges the Biopharma industry faces in new product launch sequencing. In the second part, we discuss likely ramifications…
This year brought major shifts in the pharmaceutical landscape as the Trump Administration negotiated directly with manufacturers, used tariff threats to force lower prices and reshoring, issued new executive orders on affordability and introduced a national direct-to-consumer pricing model. With policy pressure rising, 2026 will require manufacturers to translate the…
Thanks to John O’Brien and NPC, I had the privilege of recently participating on a panel at the AVBCC meeting in NYC with Beth Hamilton from Astra Zeneca. The panel was a discussion of ex-U.S. drug access and pricing and how it could impact MFN in the U.S. I wanted…
The business of bringing new medicines to market has never been more difficult. Drug costs are a major focus for policy makers, who are pushing for changes to lower what are seen as exorbitant pharmaceutical prices. The Inflation Reduction Act (IRA), passed in 2022, promises to challenge the traditional price/volume…
The challenges in bringing new products to market successfully have never been greater. In the past product approval meant demonstrating safety and efficacy to regulatory bodies in discrete countries. Clinical evidence came from trials that focused on device functionality and patient outcomes. Patients included in randomized clinical trials were subjected…
The global pharmaceutical industry is in the midst of a redefining transformation. Just as landmark scientific advances have accelerated the pace of innovation, rising costs and demands for affordable healthcare are challenging the economics and traditional business assumptions of the industry. Governments across the globe are becoming more cost-conscious as…
