The FDA approved the first generic version of injectable glucagon (1 mg/vial) packaged in an emergency kit for the treatment of severe hypoglycemia.
The agency also granted Orphan Drug Designation to Amolyt Pharma’s investigational hypoparathyroidism treatment, AZP-3601.
And in other news, the FDA authorized marketing of the EndoRotor System — the first device used to resect and remove necrotic tissue in patients with walled-off pancreatic necrosis following severe acute pancreatitis.
A few reports have popped up of COVID-19 patients experiencing euglycemic diabetic ketoacidosis while on an SGLT-2 inhibitor. “Our report reinforces that if patients are ill or have loss of appetite or are fasting, they should pause their medication and not resume until they are well and eating properly,” study author Naomi Fisher, MD, of Brigham and Women’s Hospital in Boston, said in a statement. (AACE Clinical Case Reports)
AstraZeneca announced that FDA granted dapagliflozin (Farxiga) priority review for new or worsening chronic kidney disease in adults with and without type 2 diabetes, based on findings from the DAPA-CKD trial.
Researchers at Purdue University developed a stabilized form of human calcitonin, with the hopes of treating people with osteoporosis with fewer side effects.
In related news, older folks who live alone after enduring a hip fracture were far more likely to die. (Journal of Bone and Mineral Research)
Marius Pharmaceuticals announced the submission of its new drug application to the FDA for its novel oral testosterone undecanoate (Kyzatrex), for the treatment of primary and secondary hypogonadism in adult men.
Eating more fiber was linked to a lower risk of depression in premenopausal women. (ScienceDaily)
The Mediterranean diet topped U.S. News & World Report‘s 2021 list of best overall diets.