Clinical

• The U.S. Department of Health and Human Services (HHS) and the FDA have launched an "unprecedented" initiative to restore American leadership in clinical trials and counter competition from China. • A key component of the plan is an expedited investigational new drug pilot program designed to reduce early trial timelines by as much as 12 months. • Health Secretary Robert F. Califf stated the effort aims to reverse the trend of clinical research moving overseas by making the U.S. the premier location for medicine development.

• The U.S. Department of Health and Human Services (HHS) has launched a coordinated, department-wide initiative to restore American leadership in clinical research. • The ONC is working to integrate clinical trial notifications into electronic health records to connect eligible patients with research opportunities during routine care. • ARPA-H is implementing modernization programs, including THRIVE and CATALYST, which utilize AI and machine learning to optimize dosing and predict safety before patient enrollment.

• A federal grand jury in the Southern District of Florida charged a medical doctor and two staff members for falsifying data during clinical drug trials. • Starting around 2019, the defendants allegedly fabricated testing records to falsely indicate that human subjects had taken medications and undergone required protocol testing. • The scheme targeted trials sponsored by a pharmaceutical development company intended to evaluate the safety and efficacy of new drugs for FDA approval.

• Former President Trump signed an executive order in April titled “Accelerating Medical Treatments for Serious Mental Illness” to fast-track research and drug approvals for psychedelic-assisted therapy. • The order aims to increase clinical trial participation and explore innovative research models to treat serious mental health conditions. • This federal push provides a new path for psychedelic research in Missouri, where state lawmakers have failed for several years to pass similar legislation.

• Missouri State Rep. Dave Griffith is advocating for psychedelic-assisted therapy to treat veterans suffering from depression and post-traumatic stress disorder. • The initiative follows an April executive order signed by Donald Trump titled “Accelerating Medical Treatments for Serious Mental Illness,” which aims to speed up drug approvals and clinical trial participation. • The order directs the Secretary of Health and Human Services to allocate at least $50 million to support state governments developing programs for psychedelic drugs.

• Merck (known as MSD outside the U.S. and Canada) announced the publication of new clinical trial work on May 7, 2026. • The announcement was distributed via Business Wire from Rahway, N.J., targeting both healthcare professionals and consumers. • These updates are critical for tracking new drug approvals, safety alerts, and updated indications for medical treatments.

• First Foundation Labs (1FL), a life sciences AI company spun out of Luma Group, announced a collaboration with Microsoft on June 2, 2026. • The partnership aims to integrate 1FL's clinical and translational reasoning platform into Microsoft Discovery, an enterprise AI platform hosted on Azure. • This collaboration addresses the limitations of generic Large Language Models (LLMs), which often struggle to provide reliable reasoning within complex, domain-specific scientific environments.