The year 2024 marked a pivotal moment for the pharmaceutical industry as stakeholders prepared for the Drug Supply Chain Security Act (DSCSA) interoperability deadline on November 27.
Karuna Therapeutics - A Bristol Myers Squibb Company, a cutting-edge neuroscience company, was in the midst of preparing for a critical U.S. product launch when it encountered the complex regulatory requirements of DSCSA compliance.
Exelixis, a leader in biopharmaceutical innovation, is dedicated to developing therapies that meet critical medical needs. However, as DSCSA requirements and regulations continued to evolve, Exelixis encountered obstacles in maintaining a compliance framework that could keep pace with its rapid growth.
The Informa Trade & Channel Strategies Conference has long been a key venue for addressing the challenges and opportunities shaping the pharmaceutical trade landscape.
On the latest episode of ISPE Boston Area Chapter’s The Future of Pharma podcast, Two Labs' Kyle Felmet and Riparian LLC's Jennifer Lospinoso join host Samir Gondalia to discuss how pharmaceutical companies can better navigate market access challenges.
The pharma industry can find common ground on one thing: the cell and gene therapy (CGT) space right now is both incredibly exciting and daunting. Treatments that once seemed like science fiction are now becoming reality, transforming medicine in ways we never thought possible. However, with this rapid innovation comes equally significant challenges. While new breakthroughs are on the horizon, investment is volatile, and the stakes couldn't be higher for manufacturers.
The past year has marked a turning point for cell and gene therapies (CGTs), with the Food and Drug Administration (FDA) approving seven new therapies in 2023, bringing the total number of available treatments to 34. While the industry is slightly behind the FDA’s original prediction of 10 to 20 new approvals annually by 2025, there has been a significant uptick in approvals and growth in the pipeline.
