News from Tuesday, January 27, 2026
Articles
Industry Spars Over FDA Plan to Cut Comparative Efficacy Studies for Biosimilars
(1/26, Joanne S. Eglovitch, Regulatory Focus) reports “...Biosimilar industry groups have expressed support for a recent guidance from the [FDA] that recommends the elimination of comparative efficacy studies (CES) for most biosimilar products and instead would rely on comparative analytical assessments (CAAs) to demonstrate comparability...However, [PhRMA], which represents the innovator industry, stated that the CES should be retained for novel complex products, such as multi-specific antibodies and antibody-drug conjugates.” Full
Press Releases
Truveta Launches Real-Time Clinical Trials Solution to Accelerate Study Design, Enrollment, and Evidence Generation
(1/27, Truveta Press Release) “...‘Every day matters when you are developing new therapies,’ Michael Simonov, MD, Senior Vice President of Product at Truveta. ‘With real-time data enabling sponsors to identify opportunities within days of patient encounters across our nationwide health system partners, Truveta’s new clinical trials offering brings a step-change in speed and intelligence to the entire clinical trial lifecycle.’” Full
Journals
Beyond Diuresis and Glycemic Control: Comparative Analysis of Sodiumglucose Cotransporter-2 Inhibitors (SGLT2i) vs. Furosemide and Metformin in Heart Failure (HF) Patients with Type 2 Diabetes Mellitus (T2DM) Using the TriNetX Database
Mohd Daise, et al.
January 20, 2026, Cardiovascular and Hematological Agents in Medicinal Chemistry
Comparative Effectiveness of Daily Oral and Long-Acting Injectable Prep: A Critical Review of Clinical Evidence and Public Health Implications
Ariel F T Croner, et al.
January 23, 2026, Current HIV Research
Associations Between ACO Enrollment Status and Drug and Nondrug Costs Among Older Adults Newly Diagnosed with ADRD
Seyeon Jang, PhD, et al.
January 25, 2026, The American Journal of Geriatric Psychiatry
The American Journal of Geriatric Psychiatry
Comparative Effectiveness of Arthroscopic-Assisted Versus Open Reduction and Internal Fixation in the Treatment of Tibial Plateau Fractures: A Retrospective Study
Zhizhong Tian, et al.
January 26, 2026, European Journal of Medical Research
Comparative Effectiveness and Cardiovascular Outcomes of Infliximab Reference Product and Biosimilars in Patients with Inflammatory Bowel Disease
Amirah H. Alnahdi, et al.
January 27, 2026, medRxiv