Bridget Silverman
Senior Editor
Latest From Bridget Silverman
Lecanemab Conversion From Accelerated To Full Approval Could Be Among Fastest Ever
Biogen/Eisai’s Phase III data is on track for a Q1 2023 submission, potentially just weeks after lecanemab is expected to gain accelerated approval for early Alzheimer’s.
The Real World Is Not Enough: Comparability Is Common Obstacle For RWE In US FDA Decisions
Unsuccessful attempts to use real-world evidence for approvals highlight the need to demonstrate relationship between real-world data and clinical trial patients. The Pink Sheet examines what went wrong for Bluebird/Bristol’s Abecma, Ultragenyx’s Dojolvi, and Karyopharm’s Xpovio.
Accelerated Approval For Bluebird’s Skysona Gives Teeth To US FDA Data Questions
Two required confirmatory studies will bolster application that relied on historical controls for orphan neurodegenerative disease.
Keeping Track: Terliprez, Sotyktu Keep Up US FDA’s Novel Approvals Pace; Submissions By Pfizer, Chiesi And BioLineRx
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
RWE By The Numbers: Breaking Down FDA's Use Over The Years
Pink Sheet infographic details which kinds of of applications have been able to benefit from the US FDA’s increasing use of real-world evidence.
RWE’s Biggest Role In US FDA Approvals: External Controls For Breakthrough Rare Disease Therapies
Despite broad interest, real-world evidence of efficacy in FDA decisions remains largely limited to orphan diseases and natural history, a Pink Sheet analysis shows.