Friday, September 4, 2015
FDA Draft Guidance on Male-Mediated Developmental Risks for Pharmaceuticals
Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, has been approved by the FDA for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol.
A new study will expose healthy adult volunteers to respiratory syncytial virus (RSV), a virus that causes cold-like symptoms in adults. Better understanding of how adults develop RSV infection and immune system responses to infection will assist researchers in developing and testing future antivirals and vaccines to combat the virus. The research is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
Greenphire, a King of Prussia, Pa.-based provider of payment technology for the clinical trials industry, has announced that Duke University has selected its ClinCard system to support financial data management and tracking in more than 3,000 clinical studies that the organization conducts each year. As one of the largest biomedical research enterprises in the U.S., Duke will implement Greenphire’s solution to automate the management of payments, and associated data, it makes to research participants annually.
Agilent Technologies is collaborating with Dr. Steven Gross, a faculty member in the department of pharmacology at Weill Cornell Medical College in New York, to advance research in amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. Agilent will provide the latest mass spectrometry technology to support his research, working toward an understanding of how the most common form of the disease develops in the body.
The FDA has approved an expanded use for Novartis’ Promacta (eltrombopag) to include children age 1 and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 and older and in 2008 for use in adult patients with the same condition.