| A Case for Those Extra 10 Pounds A body of research is emerging that suggests that there's little risk to carrying a few extra pounds. And there may even be some benefit. online.wsj.com |
Digital Pathology Will Usher in a New Era of Personalized Medicine Joseph Krueger submits: The Human Genome Project (HGP) was a 13-year project coordinated by the U.S. Department of Energy and the National Institutes of Health in cooperation with genetic bioscience giants Celera Genomics (CRA), Incyte (INCY), and Human Genome Sciences (HGSI). The Human Genome Project aimed to tell us what the sequence of the average person’s genetic code is “supposed” to be, and gave the necessary information for publicly funded research as well as for-profit research to begin understanding how the differences between individuals DNA affect health and disease. Indeed, this information gave rise to the concept of “personalized medicine”, which seeks to use precise genetic information about individual patients to custom tailor their mode of therapy for a disease. This concept of personalized medicine has fueled the growth of multi-billion dollar companies like Myriad Genetics (MYGN), Sequenom (SQNM), Illumina (ILMN), and Affymetrix (AFFY). We have been hearing about the promise of “personalized medicine” for over a decade now, but what has come of it? It has long been predicted that diagnostics based on genetic information brought forward by the human genome project would bring more targeted and cost-effective therapies. However, to date, almost 20 years later, there are only a few examples that have come to fruition. In general, large pharma has been slow to implement useful companion tools to apply the concept of personalized medicine to their clinical drugs. The idea seems simple: Along with the drug, create a companion diagonostic that will determine the correct course of therapy for the patient. More specifically, the companion diagnostic will predict ahead of time whether or not patients will respond to the drug.Complete Story » seekingalpha.com |
Monoclonal Antibody Companies Command Premiums Michael Becker submits:Monoclonal antibodies, which have been approved for immunological, anti-infective, ophthalmic, cancer and other categories, represent one of the most successful therapeutic drug classes. Ten monoclonal antibodies have been approved for cancer therapy alone, including three blockbuster products sold by the Roche Group (RHHBY.PK) – Avastin® [bevacizumab], Rituxan® [rituximab], and Herceptin® [trastuzumab] that collectively represented nearly US$17 billion in revenue for 2009 [Ref 1]. Hundreds of promising new product candidates are in clinical trials and by 2016 Evaluate Pharma projects that monoclonal antibody products will represent 11 of the top 50 [22%] selling products in the world, including 6 of the top 10 selling products [Ref 2].With few exceptions, companies with monoclonal antibody platforms have significantly outperformed the NASDAQ Biotechnology Index® (NBI) since the end of 2008 [see Table 1]. Accordingly, the purpose of this article is to offer several key factors that help explain the above average returns for monoclonal antibody companies during this +18-month period – a trend that we believe is likely to continue.Complete Story » seekingalpha.com |
Good News for Alimera’s Pipeline Zacks.com submits: Recently, Alimera Sciences’ (ALIM) pipeline received a boost when the US Food and Drug Administration ("FDA") accepted the New Drug Application ("NDA") for its lead candidate, Iluvien. Furthermore, the agency has decided to review the application on a priority basis. The company is looking to gain approval for Iluvien for the treatment of diabetic macular edema (DME).The company filed the NDA with the FDA in late June 2010. The US regulatory authority generally reviews those drugs on a priority basis, which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission instead of the usual ten months. Based on that criterion, a response from the FDA should be out in the fourth quarter of 2010.Complete Story » seekingalpha.com |
WellPoint Unit to Reimburse Policyholders A WellPoint subsidiary in Colorado agreed to repay policyholders in that state $20 million after an examination by the state insurance commissioner concluded that several premium increases were unjustified. online.wsj.com |