The developers of survodutide and elsunersen will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

Brian Scanlan, operating partner (life sciences), Edgewater Capital Partners, in an interview with Scrip, outlines where things may be headed in the CRO/CDMO segment amid big pharma streamlining efforts, “belt tightening” by emerging biopharma, down rounds and heightened geopolitical tension.

With the success of the partnership between J&J and partner Legend, more Chinese cell therapy developers are now looking to enter the US market. But for a complex product like a CAR-T therapy, the journey to the West is not short of challenges. Nasdaq-listed Gracell Bio wants to give it a shot based on quicker delivery and cost-effectiveness advantages.

FDA initiative aimed at optimizing cancer drug dosage earlier in development started with single-agent therapies, but moving into combinations is ‘a natural progression,’ Oncology Center of Excellence’s Richard Pazdur says. At a recent workshop, experts discuss considerations for combination product dosage optimization and review case studies that reflect Optimus principles.