Breaking the Amendment Cycle: How Agentic AI Enables Smarter Clinical Trial Design and Operations
Faster trials are not a vanity metric. They reflect an undeniable need: getting safe therapies to patients sooner.
Faster trials are not a vanity metric. They reflect an undeniable need: getting safe therapies to patients sooner.
Prediction market Kalshi launched betting markets tied to clinical trial results and FDA approvals. Healthcare leaders warn the model could invite insider trading and distort the integrity of the research outcomes it's meant to forecast.
Healthcare decision-makers, especially at pharmaceutical companies, must prioritize patient input. Data collected from social media listening is a significant step in the right direction.
Organizations that can generate and apply high-quality, clinically grounded evidence will be better positioned to close the gap between what is proven in trials and what is achieved in practice.
CTMS platforms do not lack capability. They reflect an earlier architectural priority.
Verily and Samsung are partnering to integrate data from Galaxy smartwatches into Verily’s Pre platform. The goal is to create an end-to-end system that pharma researchers can use to deploy wearable devices in studies, analyze patient data remotely and then interpret the results.
Petrelintide posted Phase 2 results showing tolerability comparable to a placebo, but average weight loss that was less than what analysts expected. The Zealand Pharma drug, in development under a partnership with Roche, is a peptide engineered to activate the amylin receptor.
Brian Alexander feels the current system of drug development is shaped by biotech investor expectations. Valo Health is eschewing that path.
Across all industries, the total number of companies on track to go public could make this week the most active for IPOs since 2021. Despite the partial government shutdown, there are paths biotechs can pursue to the public markets.
The Digital Medicine Society (DiME) launched a new set of FDA-aligned digital measures to standardize how outcomes are tracked in pediatric rare disease trials. The framework aims to make trials faster and more efficient, giving researchers and drugmakers a practical roadmap for developing new therapies for children who often have no effective treatment options.
Preliminary Phase 2 data show Roche’s CT-388 led to a 22.5% placebo-adjusted weight loss measured at 48 weeks. Based on these results, the pharmaceutical company plans to advance the GLP-1 and GIP agonist to a Phase 3 clinical trial in obesity.
Crescent Biopharma gains rights to a Kelun-Biotech antibody drug conjugate it plans to test in combination with its lead cancer drug, a bispecific antibody designed to block PD-1 and VEGF. Separately, Crescent raised $185 million in a private placement to support its clinical trial plans.
Cleveland Clinic is expanding its use of Dyania Health’s AI platform across the health system to speed up clinical trial recruitment. The system quickly scans patient records to identify eligible participants, aiming to give more patients access to trials and speed up development timelines for new therapies.
Prioritizing risk-based management, data science, smart automation, standards, and patient optionality are critical for the industry to keep up with market changes. The recent FDA guidance that encourages ‘pragmatic trials’ in specific scenarios is a move in the right direction.
AbbVie has acquired rights to a multispecific antibody that IGI Therapeutics designed to bind to three targets to treat multiple myeloma. Early Phase 1 results showed encouraging responses in a heavily pretreated patient population and a favorable safety profile.
The ability to harness real-world insights at scale empowers life sciences companies and clinicians to develop more targeted therapies, improve patient outcomes, and drive evidence-based innovation in BPH treatment.