The Tufts Center for the Study of Drug Development (CSDD) released a new report highlighting innovative approaches across the R&D continuum that pharmaceutical companies are implementing to drive efficiency and lower cost.
The Tufts Center for the Study of Drug Development (CSDD) released a new report highlighting innovative approaches across the R&D continuum that pharmaceutical companies are implementing to drive efficiency and lower cost. The new report, entitled "Profiles of New Approaches to Improving the Efficiency and Performance of Pharmaceutical Drug Development," details six primary areas across scientific, operating and manufacturing divisions including new approaches to validating drug targets; integrating real world data into the R&D process; flexible and adaptive clinical trials; and green manufacturing techniques driving efficiency while reducing carbon footprint.
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AbbVie Submits sNDA to FDA for Venclexta-Acalabrutinib Combo in Frontline CLL
July 29th 2025The application is backed by Phase III AMPLIFY trial results showing the oral combination significantly improved progression-free survival versus chemoimmunotherapy in previously untreated chronic lymphocytic leukemia.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
J&J Submits sBLA to FDA for Tremfya Label Expansion Based on PsA Joint Damage Inhibition Data
July 29th 2025The submission is supported by Phase IIIb APEX trial results showing Tremfya reduced symptoms and inhibited structural progression in biologic-naïve patients with active psoriatic arthritis.