Changing Tirzepatide Dose Utilization in Japan: Evidence from National Outpatient Claims Data

Changing Tirzepatide Dose Utilization in Japan: Evidence from National Outpatient Claims Data

Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, has emerged as an important therapeutic option for type 2 diabetes mellitus (T2DM). While clinical trials have established its efficacy, real-world evidence describing prescribing behavior and dose utilization after market introduction remains limited. This study assessed outpatient dispensing patterns and changes in tirzepatide strength mix in Japan using nationwide administrative claims data.

Pharmacogenomics-Guided CCB Therapy Improves BP Control in Chinese Patients with Hypertension

Pharmacogenomics-Guided CCB Therapy Improves BP Control in Chinese Patients with Hypertension

Interindividual variability in antihypertensive drug response presents a major challenge in achieving optimal blood pressure (BP) control. Pharmacogenomics (PGx) offers an opportunity to individualize therapy by identifying genetic variants associated with differential drug efficacy and metabolism. This study evaluated the association of a calcium channel blocker (CCB)-related PGx-guided treatment strategy with BP outcomes and short-term safety in Chinese patients with hypertension through a secondary exploratory analysis of two randomized cohorts.

Lupin Gains FDA Approval and Launch of Generic Sugammadex Injection

Lupin Gains FDA Approval and Launch of Generic Sugammadex Injection

Lupin Limited has announced the U.S. Food and Drug Administration (FDA) approval and commercial launch of Sugammadex Injection, reinforcing its presence in the U.S. hospital injectable market. Sugammadex is a selective neuromuscular blockade reversal agent used to rapidly reverse the effects of rocuronium bromide and vecuronium bromide during surgical procedures. The approval follows the company’s earlier tentative approval and enables commercial availability in the United States.

REST Trial to Evaluate Cardiometabolic Recovery Following Semaglutide Withdrawal

REST Trial to Evaluate Cardiometabolic Recovery Following Semaglutide Withdrawal

The Recovery Effects After Semaglutide Termination (REST) trial is a prospective, randomized, open-label clinical study designed to investigate the physiological and cardiometabolic consequences of discontinuing semaglutide therapy in individuals with obesity. Although semaglutide has demonstrated substantial and sustained weight reduction together with improvements in cardiometabolic risk factors, there is limited evidence regarding the optimal strategy for treatment discontinuation. Previous studies have shown that stopping semaglutide is frequently associated with weight regain and reversal of metabolic benefits, highlighting obesity as a chronic disease that may require long-term pharmacological management.

Cipla Secures U.S. FDA Approval for Generic Advair Diskus®

Cipla Secures U.S. FDA Approval for Generic Advair Diskus®

Cipla has achieved a significant milestone with the U.S. Food and Drug Administration (USFDA) granting approval for its Abbreviated New Drug Application (ANDA) for the generic version of Advair Diskus® (fluticasone propionate and salmeterol inhalation powder). The approval covers all three strengths—100/50 mcg, 250/50 mcg, and 500/50 mcg—and allows Cipla to market a therapeutically equivalent alternative to one of the most widely prescribed inhaled combination therapies for asthma and chronic obstructive pulmonary disease (COPD).

Comparative Study Evaluates Cancer Risk Associated with ACE Inhibitors and ARBs

Comparative Study Evaluates Cancer Risk Associated with ACE Inhibitors and ARBs

Concerns regarding the long-term carcinogenic potential of renin–angiotensin system (RAS) inhibitors have generated considerable debate over the past decade. To better clarify this association, a comparative analysis published in PLOS ONE evaluated the relationship between angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) and the risk of developing cancer. Using a large real-world population dataset, the investigators compared cancer incidence among patients receiving ACEIs or ARBs while adjusting for relevant demographic and clinical confounding factors.

FDA Approves JIDEYTRO® (Zidesamtinib) for Previously Treated ROS1-Positive Advanced NSCLC

FDA Approves JIDEYTRO® (Zidesamtinib) for Previously Treated ROS1-Positive Advanced NSCLC

The US Food and Drug Administration (FDA) has approved GSK’s JIDEYTRO® (zidesamtinib) for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) whose disease has progressed following prior ROS1 tyrosine kinase inhibitor (TKI) therapy or platinum-based chemotherapy. The approval introduces a next-generation, highly selective ROS1 inhibitor designed to overcome resistance mechanisms associated with earlier-generation ROS1-targeted therapies while maintaining robust central nervous system (CNS) penetration.

Pfizer’s TALZENNA–XTANDI Combination Receives FDA Priority Review Following Positive TALAPRO-3 Results

Pfizer’s TALZENNA–XTANDI Combination Receives FDA Priority Review Following Positive TALAPRO-3 Results

Pfizer has announced that the US Food and Drug Administration (FDA) has accepted for Priority Review its supplemental New Drug Application (sNDA) for TALZENNA® (talazoparib), a poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide) for the treatment of adults with metastatic castration-sensitive prostate cancer (mCSPC) harboring homologous recombination repair (HRR) gene alterations. Priority Review designation shortens the FDA review timeline for therapies that may provide significant improvements in the treatment of serious diseases, underscoring the potential clinical importance of this combination in an area of unmet need.

Retatrutide Achieves Robust Weight Loss and Glycaemic Control in Two Additional Phase 3 TRIUMPH Trials

Retatrutide Achieves Robust Weight Loss and Glycaemic Control in Two Additional Phase 3 TRIUMPH Trials

Eli Lilly has reported positive topline results from two additional Phase 3 studies in its TRIUMPH clinical development programme, further establishing the efficacy of retatrutide, an investigational first-in-class triple hormone receptor agonist targeting glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon receptors. The TRIUMPH-2 and TRIUMPH-3 trials evaluated retatrutide in adults with obesity complicated by type 2 diabetes and established cardiovascular disease, respectively. Both studies successfully met their primary efficacy endpoints after 80 weeks of treatment.