Entries by aaron

Reduce PSA level to less than 4 in inclusion criteria: CDSCO Panel Tells Akum Drugs and Pharmaceuticals on FDC Dutasteride plus Silodosin

New Delhi: Reviewing the active post-marketing surveillance (PMS) protocol of fixed-dose combination (FDC) Dutasteride plus Silodosin presented by Akums Drugs and Pharmaceuticals, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to modify inclusion criteria by reducing the Prostate-Specific Antigen (PSA) level to less than 4 […]

USFDA successfully concludes inspection at Piramal Pharma USA facility

Mumbai: Piramal Pharma Limited has informed through a recent BSE filing that the US Food and Drug ADministration (US FDA) has issued an Establishment Inspection Report (EIR) for the Riverview, USA manufacturing facility and the inspection has now been successfully closed by the US FDA. Medical Dialogues team had earlier reported that the US FDA had concluded a Pre-Approval […]

Prediabetes Needs Proactive Management In India: Why?

Prediabetes, also termed intermediate hyperglycemia or non-diabetic hyperglycemia, a high-risk state for developing diabetes, is defined by glycaemic variables that are higher than normal but lower than the thresholds for diabetes. It includes impaired fasting glucose (IFG) and impaired glucose tolerance (IGT). According to the American Diabetes Association (ADA), IFG 100-125 mg/dL (5.6 and 6.9 […]

Plozasiran effective for reducing triglyceride level in patients with severe hypertriglyceridemia: SHASTA-2 trial

USA: Findings from the SHASTA-2 randomized clinical trial (RCT) published in JAMA Cardiology have demonstrated the potential clinical utility of plozasiran to reduce triglyceride (TG) levels in patients with severe hypertriglyceridemia (sHTG). The phase 2b randomized clinical trial of 229 patients with sHTG revealed that subcutaneously administered plozasiran (dosed on day one and week 12) […]

Endoscopic Sleeve Gastroplasty Cost-Effective Than Semaglutide in Obesity Treatment: JAMA

A recent study determined that a minimally invasive bariatric procedure called Endoscopic Sleeve Gastroplasty (ESG) is more cost-effective than the latest weight-loss medication, semaglutide, for treating the individuals with class II obesity. This study was conducted from September 2022 to May 2023 which elucidates critical insights into the financial and health impacts of obesity treatments […]

Chronic exercise tied to lower appetite in patients with type 2 diabetes: Study

Germany: A systematic review published in Nutrients has shed light on the impact of acute and chronic exercise on appetite and appetite regulation in patients with prediabetes or type 2 diabetes mellitus (T2DM). The review of seven studies involving individuals with prediabetes or Type 2 diabetes found that chronic exercise may be associated with reduced […]

Orally inhaled flecainide favorable for conversion of atrial fibrillation to sinus rhythm: Insights from INSTANT phase 2 trial

USA: Findings from the INSTANT phase 2 trial showed that orally inhaled flecainide passed muster for converting atrial fibrillation (AF) to sinus rhythm. The findings were published online in JACC: Clinical Electrophysiology on April 10, 2024. INSTANT was an open-label, multicenter, single-arm study of flecainide acetate oral inhalation solution (FlecIH) for acute conversion of recent-onset […]