Top-line data from three Phase III trials of simeprevir (TMC435) in patients with hepatitis C virus (HCV) genotype 1 infection appear to confirm what Medivir AB has always maintained – that it has a potentially best-in-class protease inhibitor on its hands. Read More
It's the time of year to make lists and check them twice. Science published its Breakthrough of the Year issue describing its picks for the most important scientific advances of the year on Friday. Read More
Chronic fatigue syndrome (CFS) patients willing to take Ampligen if it's approved – and accept the risks, because it has worked for them in trials – faced off against charges of inadequately done studies with less than satisfying overall efficacy signals, during a meeting of the FDA's Arthritis Advisory Committee. Read More
HealthCare Royalty Partners II LP closed an $80 million financing with privately held Nuron Biotech Inc. that included a $30 million equity investment and a $50 million synthetic royalty agreement linked to future sales of Meningitec, a vaccine Nuron acquired earlier this month from Pfizer Inc., and its HibTiter vaccine (Haemophilus b conjugate vaccine [diphtheria CRM197 protein conjugate]). Read More
• Dendreon Corp., of Seattle, said it sold its immunotherapy manufacturing facility in Morris Plains, N.J., to Novartis Pharmaceuticals Corp., a unit of Basel, Switzerland-based Novartis AG, for $43 million in cash. Read More
• Merrimack Pharmaceuticals Inc., of Cambridge, Mass., enrolled its first patient in a study of biomarkers in advanced colorectal, lung and triple-negative breast cancer for estimating delivery of compound MM-398 to tumors and for patient response to the drug. Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, said U.S. prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement. Read More
• Merck and Co Inc., of Whitehouse Station, N.J., reported that its large study of Tredaptive (extended-release niacin/laropiprant) missed its primary endpoint. The trial enrolled 25,673 patients at high risk for cardiovascular events, and followed them for a median of 3.9 years while they received Tredaptive therapy plus statin therapy or statin therapy alone. Read More
