FDA: 35 innovative new drugs approved in fiscal year 2011 — Report shows quick approvals of safe and effective medicines occur in the United States before other countries – Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines for patients, like two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.
The U.S. Food and Drug Administration (FDA) approves Incivek for hepatitis C – The U.S. Food and Drug Administration approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies.
HIV Infection May Be a Risk Factor for Heart Failure – Patients with HIV infection without a prior history of coronary heart disease may be at a higher risk of developing heart failure, according to a report in the Archives of Internal Medicine.
Research suggests HIV-infected patients at higher risk for bone fractures — Study compared fracture rates among HIV patients with general US population – Low bone mineral density in HIV-infected patients is common and raises concerns about increased risks of fracture, revealed by researchers.
New drug technology produces marked improvement in hepatitis C therapy in animals – In a dramatic finding, a new drug for hepatitis C virus (HCV) infections that targets liver cells produced a substantial drop in blood levels of the virus in animals and continued to work up to several months after treatment, say scientists at the Southwest Foundation for Biomedical Research (SFBR) in San Antonio.
New Biomarker Predicts Response to Hepatitis C Treatment – Researchers at Duke University Medical Center have identified the first genetic marker that predicts response to hepatitis C treatments, and a single letter of DNA code appears to make a huge difference.
HIV positive and HIV negative patients have similar survival rates following liver transplant. – HIV positive and HIV negative patients have comparable survival rates following liver transplant, according to new research presented today at EASL 2009, the Annual Meeting of the European Association for the Study of Liver in Copenhagen, Denmark.
Human Genome Sciences Announces Positive Results In Second Of Two Phase 3 Trials Of Albuferon(R) In Chronic Hepatitis C – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced that Albuferon (albinterferon alfa-2b) met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) in ACHIEVE 1, a Phase 3 clinical trial of Albuferon in combination with ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C (p=0.0008).
Treatment for advanced hepatitis C doesn’t work, researchers find. NIH study shows decline in health of those with advanced liver disease due to hepatitis C. – An NIH funded multi-center clinical trial found no benefit from “maintenance therapy,” low-dose peginterferon used for hepatitis C patients who have not responded to an initial round of treatment.
DNA sequencing establishes high throughput genetic sequencing as powerful tool for pathogen discovery; technology enables improvements in screening for transplant safety. – In the first application of high throughput DNA sequencing technology to investigate an infectious disease outbreak, link the discovery of a new arenavirus to the deaths of three transplant recipients who received organs from a single donor in Victoria, Australia in April 2007.