Novo Nordisk plans to file for regulatory approval of the 25mg and 50mg dosage strengths in 2023.
Endocrine Disorders
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Though 295 drugs were in shortage last year, the latest number is 130; about 15 critical drug products have been scarce for a decade.
Both products were discontinued because of a business decision and not due to safety or efficacy-related concerns.
Greater percentage of time with glucose level in target range seen for young children using closed-loop system.
Sanofi is the third company to cut prices on its insulin products and cap out-of-pocket charges to $35 a month.
Higher genetically predicted plasma caffeine concentrations linked to lower risk for type 2 diabetes, with 43% of effect mediated by BMI.
Multifaceted intervention of assessment, education, and feedback increases likelihood of triple prescription fourfold over usual care
News follows similar move made by Eli Lilly, which said earlier this month that it will cut insulin prices by 70 percent
The sNDA is supported by data from the phase 3 DINAMO trial, which include patients 10 to less than 18 years of age with type 2 diabetes who are currently receiving metformin, insulin, or both.
Stimulated C-peptide secretion partially preserved with verapamil versus placebo at 52 weeks after diagnosis of type 1 diabetes
The Company is now working with insulin pump manufacturers to integrate their AID systems with the FreeStyle Libre 2 and FreeStyle Libre 3 sensors.
Significant reductions seen in weight, HbA1c, total daily dose of insulin with GLP-1RA, and in HbA1c and basal insulin with SGLTi
Company will cut its list price for Humalog 100 units/mL starting in the fourth quarter of 2023
82.3 percent of U.S. adults with type 2 diabetes meet recommended criteria for use; 9.1 percent used either of them
Despite a warning from the FDA Adverse Event Reporting System, studies have found that SGLT2 inhibitor use is not associated with an increased risk of AKI.
Reduction in risk was greatest for those with history of ischemic heart disease or stroke
Increases seen in brain processing, penile tumescence, and behavioral measures of sexual desire and arousal
Likelihood of regression to normal glucose regulation also increased for individuals with prediabetes taking vitamin D
A recent posting on the FDA’s Drug Shortages tracker indicates that the product has been discontinued.
The use of recalled products may lead to signs and symptoms of hypothyroidism.