FDA Updates: Merck’s Pneumococcal Vaccine Leads the Week

July 24, 2021

New vaccine for pneumococcal disease, an sNDA approved based on real-world data, a new therapy for skin and muscle disease, Keytruda combination receives full approval in endometrial cancer, a new diabetes therapy is approved, and another JAK inhibitor misses PDUFA date round out this week’s FDA news.

FDA Update: Keytruda and Aduhelm News Leads the Week

July 10, 2021

Keytruda loses one indication but gains another, Biogen narrows use of Aduhelm, Padcev gets regular approval and expanded indication, Amgen submits application for asthma biologic, agency issues complete response letter for diabetes prevention therapy teplizumab, Novartis resubmits NDA for inclisiran.

Today’s Effects of Telehealth When Caring for Diabetic Children

April 23, 2021

Dr. Kathleen Bethin, clinical professor, and Dr. Lucy Mastrandrea, associate professor and division chief of endocrinology/diabetes both at the Jacobs School of Medicine & Biomedical Sciences at the University at Buffalo, spoke with Vic Baldry of Cecelia Health to discuss the challenges telehealth has created when caring for families with children who have type 1 diabetes.

SGLT2 Inhibitor Use Stunted for Black, Female, Lower Income Type 2 Diabetes Patients

April 21, 2021

Access to care and other health disparities result in the low use of novel therapies for Black, female and lower income type 2 diabetes patients. If these barriers aren't addressed, disparities among kidney and cardiovascular patients may worsen in the U.S.