July 4th 2025
Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
Behind the Headlines: Mpox Resurges; Eli Lilly Adds CGT Facilities; FDA Updates
August 21st 2024This Behind the Headlines news roundup panel discussion covers news items such as the resurgence of mpox in Africa, “medical tourism” in India, Eli Lilly’s new Boston CGT facilities, and contract development and manufacturing organization (CDMO) projected growth rates for the 2023–2029 period, and the reasons behind them.
Severe Eosinophilic Asthma Maintenance Treatment Approved in China for Ages 12 and Up
August 20th 2024Fasenra, which has been approved since 2019 in the United States in a pre-filled, single-use auto-injector form that can be administered either in a doctor’s office or at home, is now approved in China for age 12 and up.
GSK’s Application Seeking Blenrep Combinations for Treating Multiple Myeloma Accepted by EMA
July 25th 2024GSK's MAA is supported by an interim analyis of Phase III trials, which demonstrated significant progression-free survival benefit and positive overall survival trends from Blenrep combination therapies.
FDA Draft Guidance Seeks to Support Drug Developers for Pediatric Inflammatory Bowel Disease
July 23rd 2024While the document does not address treatment or prevention of the long-term complications of ulcerative colitis or Crohn’s disease in children, it aims to help sponsors developing drugs for pediatric patients currently affected.