LONDON – “I believe the world is on the verge of an effective Ebola vaccine.” So said Marie-Paule Kieny, assistant director general of the World Health Organization (WHO) announcing positive results for the phase III trial of the Merck and Co. Inc./Newlink Genetics Corp. VSV-EBOV vaccine in Guinea. Read More
Friday’s report that the Merck and Co. Inc./Newlink Genetics Corp. VSV-EBOV vaccine was effective at preventing infections also shone a spotlight on the method used to test the vaccine, namely, ring vaccination. Read More
Considering its relatively inconspicuous presence in the body, the pancreas can wreak havoc on human health through two major diseases: diabetes and pancreatic cancer. Both can be deadly – the former from the condition itself or from long-term complications and the latter from advanced disease that may be symptomatic for only months or even weeks. Neither has a cure. Read More
Amgen Inc. shares (NASDAQ:AMGN) briefly hit a record high of $181.81 on Friday as the drugmaker reported a higher-than-expected second quarter profit, driven in part by strong sales of Enbrel (etanercept), Prolia and Xgeva (denosumab) and cost-cutting. The drugmaker also raised its full-year guidance as it moved to launch new products, such as the world’s first approved PCSK9 inhibitor, Repatha (evolocumab). Read More
A wider-than-expected second quarter loss and plans to halve the sales team for obesity drug Qsymia (phentermine/topiramate) took a bite out of Vivus Inc.’s shares Friday, but more troubling news for the Mountain View, Calif.-based company – and its competitors – may be the excruciatingly slow uptake in the branded obesity drug market as a whole. Read More
Alexion Pharmaceuticals Inc., of Cheshire, Conn., said net product sales of Soliris (eculizumab) grew to $636 million in the second quarter, a 24 percent increase, compared to $512.5 million for the same period in 2014, despite currency headwinds. Non-GAAP diluted earnings per share for the second quarter of 2015 were $1.44, compared to $1.12 in the second quarter of 2014. On a GAAP basis, diluted EPS for the second quarter of 2015 was 83 cents per share, impacted by $40.1 million, or 20 cents per share. Read More
Adma Biologics Inc., of Ramsey, N.J., said it submitted a biologics license application to the FDA seeking approval of RI-002, a specialty plasma-derived, polyclonal, intravenous immune globulin derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B, cytomegalovirus, measles, tetanus, etc.) as well as standardized, high levels of antibodies to respiratory syncytial virus. The drug demonstrated positive results in a phase III study in patients with primary immunodeficiency (PI), meeting its primary endpoint of no serious bacterial infections (SBI). Those results, included in the submission, more than meet the requirement specified by the FDA guidance of less than or equal to one SBI per patient-year, the company said. PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly. It affects roughly 250,000 people in the U.S. Read More
Amarin Corp. plc, of Dublin, disclosed the presentation of findings from two studies, a retrospective study in which patients were switched from an EPA plus DHA combination product to EPA-only Vascepa (icosapent ethyl) as well as a sub-analysis of the Anchor trial at scientific cardiovascular meetings. The eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA)to EPA-only switch study investigated the effect of EPA-only omega-3 therapy compared to EPA plus DHA therapy on multiple patient lipid parameters. Results showed a reduction in both triglyceride and low-density lipoprotein cholesterol levels with EPA-only therapy in most of these high-risk statin-treated patients. The Anchor sub-analysis related to a study that examined the effect of EPA on high-risk statin-treated patients with persistently high triglyceride levels, showing that icosapent ethyl increased EPA in plasma and red blood cells in a linear, dose-dependent fashion consistent with its triglyceride-lowering effect, Amarin said. Read More
Egalet Corp., of Wayne, Pa., completed its previously disclosed underwritten public offering of about 7.6 million shares at $11.25 each, for gross proceeds of about $86.3 million. Stifel and Guggenheim Securities acted as joint bookrunning managers for the offering. Read More
The CONVERGE consortium has identified the first genetic risk loci for depression. Genetic risk factors for major depressive disorder have been surprisingly hard to pin down, with several major genomewide association studies coming up empty. Read More
