It's been a rough couple of weeks for Intercept Pharmaceuticals Inc. In the middle of September, Intercept issued a Dear Healthcare Provider letter stressing the importance of proper dosing of its primary biliary cholangitis (PBC) treatment, Ocaliva (obeticholic acid), in patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis) who are supposed to take 5 mg of Ocaliva once weekly, with the possibility to gradually increase to a maximum of 10 mg twice weekly. Instead, some doctors were giving the dose for patients with no or mild hepatic impairment (noncirrhotic or Child-Pugh A cirrhosis), which starts at 5 mg once daily – seven times the dose for patients with moderate or severe hepatic impairment. Read More
The clock is ticking on the lofty goals established five years ago for the London Declaration on Neglected Tropical Diseases (NTDs), where 13 major biopharmaceutical companies banded together with government health and overseas aid ministers, and the heads of agencies including the World Health Organization (WHO) and the World Bank, all of whom committed to contain or eliminate 10 of these diseases by 2020, including Chagas disease, caused by the parasite Trypanosoma cruzi, which is a major health care problem. WHO estimates that 10 million to 13 million people are chronically infected by the disease globally. There also may be as many as 300,000 people in the U.S. that have the disease according to the CDC. Although the acute phase of Chagas disease is usually asymptomatic, and remains so for many infected individuals, up to 30 percent of those infected can develop potentially life-threatening cardiovascular, gastrointestinal and neurological complications. Read More
