Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
DengiAll will be the first indigenous single-shot dengue vaccine in India and is expected to enter the markets by 2027
SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage
Mepolizumab is the first and only monthly biologic in China tested for COPD patients with blood eosinophil counts (BEC) as low as 150 cells/µL
Fasting glucose improved by 12.3 mg/dL, while liver stiffness dropped 23.7%, signaling a direct hepatic benefit
The approval introduces a needle-free alternative to injectable GLP-1 therapies
The approval is supported by data from three pivotal clinical trials
The trials did not show a statistically significant reduction in annualized clinical fracture rates compared to placebo or bisphosphonates
The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026
Despite some promising subgroup signals, the company indicated it will not pursue further psychiatric trials
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