CRO

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.

Novotech's CEO talks about rising interest for trials in regions with “regulatory agility” and “strategic insulation” from geopolitical complexity, especially among emerging and mid-sized biotech sponsors. Operational "reassessment” among some sponsors on exposure to China-based CROs/CRDMOs is another area he discussed.

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?

Parexel's CEO Peyton Howell and India boss Sanjay Vyas talk to Scrip about the value of clinical trial diversity, AI pilots underway and opportunities for India amid geopolitical rumblings, as well as the need for standardized regulatory approaches to enhance sponsor interest.