Search Results

Nottingham, UK - Upperton has submitted its application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the approval of its new 7,000 sq. ft sterile manufacturing facility. The submission follows the successful execution of multiple aseptic process simulations (APS media-fill batches), completed in accordance with the revised EU GMP Annex 1 (2023) requirements.

• Meetings with all four regulatory agencies scheduled to occur in the second quarter of 2026, with expected Phase 3 commencement in the third quarter of 2026 initially in Australia • Commencing the Phase 3 confirmatory study is a pre-requisite to being granted a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisations (CMAs) in the U.K. & Europe

After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.