FDA Approves Second Cholesterol-Lowering PCSK9 Inhibitor.
The FDA approved Amgen’s Repatha (evolocumab), the second in a new class of cholesterol-lowering drugs called PCSK9 inhibitors. Repatha, which will cost $14,100 annually, is intended for patients with extremely high cholesterol levels and those with heart disease who cannot sufficiently lower their cholesterol levels with statins
Novo Nordisk Will Not Seek Expanded Indication For T1D Drug.
Novo Nordisk announced it will not seek an expanded indication for Victoza as an add-on treatment to insulin for type 1 diabetes because of disappointing phase III Adjunct One trial where the rate of severe hypoglycemia was not significantly different for the treatment and placebo groups.
FDA Approves Female Libido Treatment.
The FDA approved Addyi (flibanserin), a drug that works in a woman’s brain to solve a chemical imbalance among three neurotransmitters that impact sexual desire. The drug, which is designed to treat pre-menopausal women, is the first approved to boost female libido. Sprout Pharmaceutical believes the drug could be prescribed for as many as 10 percent of women and will be available in mid-October.
Israel Company Seeks FDA Approval Of Ear-Clip Glucose Monitoring Device.
Israel-based medical device manufacturer Integrity Applications has begun the process with the FDA to bring its noninvasive glucose monitoring device, GlucoTrack, to the United States. The device clips on to the ear and allows users to monitor their blood glucose level without drawing blood.
Novo Nordisk May Build Diabetes Drug Plant In US.
Danish drugmaker Novo Nordisk is considering building a factory in North Carolina to make an oral version of a medicine for type 2 diabetes called semaglutide.
New Analysis of LIBRA Trial Published.
Victoza over 48 weeks induced a paradoxical increase in post challenge glucagon in T2DM at 12 weeks post treatment according to a new analysis of LIBRA trial in JCEM.
Ubc9 Enzyme A Potent Negative Regulator Of Energy Storage In Human Fat Cells.
Ubc9 enzyme a potent negative regulator of energy storage in human fat cells may be a promising therapeutic target IN T2DM. The enzyme inhibits the genetic program that makes white adipocytes act more like thermogenic, fat-burning brown adipocytes להמשך קריאה
Gynecomastia In Pubertal Boys Tied To Increased IGF-1, Younger Age At Peak Height Velocity
Increased levels of IGF-1 and younger age at peak height velocity appear to be associated with gynecomastia in pubertal boys, according to a study in JCEM which evaluated 106 healthy boys aged five to 16 years, and also found that changes in ratio of estrogen to testosterone do not appear to be related to the condition
Delayed Release Metformin Delivered In Lower Bowel Results In Fasting Plasma Glucose Reductions Without Increased Risk Of Adverse Events.
Delayed release metformin (Met DR), engineered to be delivered in the lower bowel, allowed patients to ingest a lower dose of the drug, and experience equivalent fasting plasma glucose control, compared with patients taking extended release formulations, according to phase II study in Diabetes Care.