Blog

December 6, 2024
With the rise of device-specific licensing laws across states, medical device manufacturers now face a maze of new regulatory hurdles.
November 25, 2024
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.
October 21, 2024
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.
October 2, 2024
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.
September 16, 2024
The healthcare supply chain is racing against the clock as the November 27 deadline for full DSCSA compliance rapidly approaches.
August 26, 2024
The wave of FDA-approved cell and gene therapies (CGT) is transforming treatment options for diseases that once had few solutions.