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Engaging with Regulators for Single-Arm Oncology Research Trials
When well-planned and well-executed, single-arm trials can accelerate access to life-saving therapies that might otherwise never reach desperate cancer patients. read more
Hasty Decisions, Runaway Projects
Despite the best intentions of ISO and EMA, the pharma industry is still largely failing to exploit its data in a strategic, joined-up way - and this could now restrict companies’ ability to capitalize on AI. read more
Should Sponsors Provide Source Document Templates?
Sponsor-provided templates provide a compelling opportunity to improve upstream trial execution. However, in today’s world of increasingly complex and data-driven trials, the opportunity comes with important caveats. read more
Flexibility as a Core IND Strategy
With the increasing complexities of current IND programs, it is critical to work with regulatory agencies to seek input early in the process. read more

Clinical Trials - Transforming Drug Development
Transforming Drug Development: Accelerating Clinical Trials through Patient-Centric Innovations and Technological Breakthroughs Watch Now

Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate
Monday, August 03, 2026
Polpharma Biologics announced that the FDA and the EMA have accepted for review the Biologics License Application (BLA) and Marketing Authorization ... read more
Codis Completes Nottingham Deal to Expand Europe’s Spray Dry Network
Monday, August 03, 2026
Codis has completed its acquisition of Catalent’s Nottingham, UK facility, a move that expands the company’s integrated spray dry offering in Europe ... read more
Genezen, Raiden Science Foundation Partner on UBA5 Gene Therapy Manufacturing
Monday, August 03, 2026
Genezen and the Raiden Science Foundation have announced a manufacturing partnership for an AAV9 gene replacement therapy for UBA5 disorder, moving ... read more
Resilience and Lilly Invest $750M to Increase U.S.-Manufactured Medicine Supply
Monday, August 03, 2026
Resilience announced it has expanded its strategic partnership with Eli Lilly and Company to increase U.S. production of critical medicines featuring ... read more
Cellipont Bioservices Announces Release of 100th GMP Batch
Thursday, July 30, 2026
Cellipont Bioservices announced the successful release of its 100th GMP batch at its manufacturing facility in The Woodlands, Texas. read more