Don Tracy, Associate Editor

Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI and digital twin technologies are being applied to improve data transparency, ensure reproducibility, and strengthen the reliability of clinical trial outcomes.

Results from a Phase II trial (NCT06640972) showed that patients treated with RDX-002 experienced significant reductions in postprandial triglycerides, less weight regain after GLP-1 therapy, and improvements in key cardiometabolic markers.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how regulators are clarifying best practices for integrating AI and digital twins into clinical research.

The global Phase III EMPEROR trial (NCT06872125) will evaluate the safety and efficacy of zorevunersen, a novel antisense oligonucleotide designed to reduce seizures and improve cognitive and behavioral outcomes in children with Dravet syndrome.

Results from the Phase III EPCORE FL-1 trial (NCT05409066) showed that patients treated with Epkinly (epcoritamab) in combination with Rituxan (rituximab) and Revlimid (lenalidomide) for relapsed or refractory follicular lymphoma demonstrated significant improvements in overall response rate and progression-free survival.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how digital twins provide patient-level predictions that enhance trial precision, reduce enrollment needs, and support AI-driven drug development.

Results from the Phase III ATTAIN-1 trial (NCT05869903) showed that the highest dose of orforglipron achieved an average weight reduction of 12.4% in patients with obesity or overweight.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI-designed therapies and digital twin technology are accelerating clinical trials, improving data precision, and reshaping early-phase drug development.

The biotech company extends its Phase I trial (NCT06252220) of DA-1726 to eight weeks following encouraging early efficacy, safety, and weight loss data in patients with obesity.

Company opts not to advance VX-993 into pivotal development after Phase II data show no statistically significant benefit over placebo in post-bunionectomy surgical pain relief.

The Phase I/II trial will evaluate the safety and early efficacy of ABT-301 in combination with tislelizumab and bevacizumab in patients with colorectal cancer.

The FDA’s green light for a Phase II trial (JSKN003-202) of JSKN003 accelerates efforts to address platinum-resistant ovarian and related gynecologic cancers.

Results from the long-term extension of the Phase III TRAILBLAZER-ALZ 2 trial (NCT04437511) showed sustained benefits with early Kisunla treatment, including reduced risk of disease progression and high rates of amyloid clearance in early Alzheimer disease.

Results from the Phase III Clarity AD open-label extension trial (NCT03887455) suggest weekly subcutaneous maintenance dosing with Leqembi may offer a more convenient and well-tolerated alternative for patients continuing long-term treatment.

Results from the Phase III BRUIN CLL-314 trial (NCT05254743) showed that Jaypirca (pirtobrutinib) achieved superiority in overall response rates compared to Imbruvica (ibrutinib) in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Results from the Phase III VIKTORIA-1 trial (NCT05501886) demonstrated that gedatolisib administered with fulvestrant, with or without Ibrance (palbociclib), showed statistically significant and clinically meaningful improvements in progression-free survival in patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer.

Results from the Phase III PREVAIL trial (NCT05556096) of gefurulimab demonstrated a statistically significant and clinically meaningful improvement in Myasthenia Gravis Activities of Daily Living at 26 weeks compared to placebo.

Results from the Phase III ABTECT-1 (NCT05507203) and ABTECT-2 (NCT05507216) trials showed that Abivax’s obefazimod demonstrated significant clinical remission in patients with ulcerative colitis.

A new myTomorrows survey of physicians in the United States highlights the need for smarter, AI-driven tools to overcome inefficiencies in clinical trial access and improve patient care timelines.

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient population limited interpretability, preventing approval in its current form.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, discusses the importance of long-term patient retention, data accuracy, and AI-driven compliance tools in shaping the future of global obesity clinical trials.

Digital strategies such as video ads and pixel tracking helped researchers recruit faster, reach more diverse participants, and cut costs in a large-scale depression study.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world evidence is helping refine patient targeting and improve safety monitoring in obesity and endocrinology clinical trials.

The Phase III INDEPENDENCE trial (NCT04717414) failed to meet its primary endpoint of achieving transfusion independence in patients with myelofibrosis-associated anemia treated with Reblozyl (luspatercept-aamt).

Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and highlights global momentum behind Blenrep combination approvals.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.

Results from the Phase III PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) trials highlight Yeztugo’s (lenacapavir) safety and efficacy in pregnant women, young adults, and others historically excluded from HIV prevention studies.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how therapeutic alignment and cross-functional collaboration enable the company to support GLP-1 trials across multiple disease areas.

Results from a Phase Ib trial (NCT03666000) show that azer-cel demonstrated a 75% overall response rate and a 55% complete response in patients with relapsed/refractory diffuse large b-cell lymphoma.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how a focused GLP-1 task force and deep market insights are helping sponsors stand out in an increasingly competitive obesity drug landscape