FDA expanded the use of ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets without ribavirin (Viekira Pak, AbbVie) this week to treat patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A).
As organizations and politicians continue to sound the alarm that drug prices are rising, another new report confirmed the trend. Total spending on medicines in the US reached $310 billion in 2015 on an estimated net price basis, up 8.5 percent from the previous year, according to a new report from the IMS Institute for Healthcare Informatics.
FDA advisory committee recently voted to recommend approval of obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis (PBC). If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.
FDA recently approved venetoclax (Venclexta, AbbVie and Genentech) to treat chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least 1 prior therapy
While FDA’s approval last week of infliximab-dyyb (Inflectra, Celltrion and Hospira), a biosimilar to Remicade (Janssen Biotech) for rheumatoid arthritis, Chron’s disease and other conditions is positive, FDA’s approval pace for biosimilars is too slow, according to a pharmacy benefit manager (PBM).
Type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease, according to FDA’s new Drug Safety Communication.