Drug and Device World

Image Credit: Sasun Bughdaryan/Unsplash. In randomized clinical trials, measuring significant differences in how patients feel, function, or survive is often impractical. Clinical outcomes can manifest too slowly or infrequently or become difficult to attribute if confounded by subsequent treatment. In these scenarios, surrogate endpoints, measurable predictors of clinical outcomes, offer a powerful alternative.

PMN310, ProMIS’ lead product candidate for the treatment of Alzheimer’s disease, is a humanized IgG1 monoclonal antibody designed to selectively target only the toxic oligomers of amyloid-beta, believed to be among the earliest and most damaging drivers of Alzheimer’s disease, while avoiding binding to amyloid plaques and vascular deposits. Image Credit: Robina Weermeijer/Unsplash.

Image Credit: micheile henderson/Unsplash. Urologic Health, an Israeli medical device company pioneering non-invasive urodynamics, has successfully closed an $11 million seed financing round. The funding will be used to advance clinical validation, pursue FDA 510(k) regulatory clearance, and support initial commercialization efforts in the United States.

Novo Nordisk submitted a Biologics License Application (BLA) for denecimig to the US FDA in September 2025, supported by the FRONTIER clinical program (FRONTIER2, FRONTIER3, FRONTIER4). Image Credit: Novo Nordisk.

Collectively, these four studies illustrate a gastroenterology field that is increasingly interrogating root causes and developing interventions designed to modify disease trajectories rather than simply manage downstream consequences. Image Credit: Towfiqu barbhuiya/Unsplash.

The value of continuous monitoring is not merely theoretical. Real-world studies are demonstrating their practical utility across therapeutic areas. Image Credit: Joshua Chehov/Unsplash. The way clinical researchers measure patient health is undergoing a fundamental shift. For decades, the gold standard has been episodic measurement: periodic blood draws, intermittent vital signs, in-clinic electrocardiograms (ECGs), and the occasional patient-reported outcome.

The data suggests that the current narrow focus on GLP-1s may not reflect the full range of patient preferences, but rather a lack of accessible information regarding other pathways. Image Credit: Total Shape/Unsplash. A new report from Phenomix Sciences reveals a substantial information gap in the current obesity treatment landscape.

In August 2025, the US Food and Drug Administration broadened the approved use of Repatha to include adults at increased risk for major adverse CV events due to uncontrolled LDL-C. Image Credit: Amgen A new subgroup analysis from the Phase 3 VESALIUS-CV clinical trial (NCT03872401) indicates that Amgen’s Repatha (evolocumab), when added to optimized statin therapy, significantly reduces the risk of a first major adverse cardiovascular event (MACE) in high-risk patients.

Coyle predicts a shift from performance-focused DTC advertising toward genuine brand building—identity-led healthcare marketing that treats patients as participants rather than recipients. Image Credit: Christopher Alvarenga/Unsplash When the Kansas City Chiefs and Philadelphia Eagles took the field for Super Bowl LX this February, they shared the spotlight with an unexpected player: the pharmaceutical industry.

Beyond treating individual disorders, Dr. Karlin sees a broader potential impact for psychedelic medicine on the field of psychiatry itself. Image Credit: Google DeepMind/Unsplash. According to the World Health Organization, nearly 1 in 7 people in the world live with a mental disorder.