It is ‘up in the air’ what manufacturers and the FDA will have to do if an appeals court does not stay the injunction against mifepristone. More than 400 biopharma industry leaders sign a letter calling for reversal of Judge Kacsmaryk’s order and supporting the FDA’s regulatory authority.

From synthetic data to real-world data, from patient engagement to patient stratification, from combination trials to master protocols and from fully decentralized through hybrid to onsite trials, the world of clinical development is undergoing major changes. Fifty executives share their predictions around clinical trial trends for the year ahead.

During Q4, biopharmas brought in an aggregate $17.5bn in financing and device company fundraising totaled $1.9bn; while in vitro diagnostic firms and research tools players raised $848m.

Recent financings, including the $150m launch of Pathalys and a planned $100m IPO for Mineralys, illustrate the reality of biopharma funding in 2023 – that having near-term clinical trial milestones are key to fundraising this year. Companies with dwindling cash are conserving the funds they have left.