| In-Line Quarter for Luminex Zacks.com submits: Luminex Corporation’s (LMNX) first quarter 2010 earnings of 5 cents per share were in line with the Zacks Consensus Estimate. The company earned 4 cents (excluding special items) in the year-ago quarter. Total revenues for the reported quarter climbed 30% year over year to $33.3 million. Revenues from the Technology segment came in at $25.2 million as against $21.1 million in the year-ago quarter. Assay group sales for the quarter came in at approximately $8.1 million, as against approximately $4.5 million in the comparable quarter of 2009.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 |
Avanir’s STAR Trial: Offering Clarity to the FDA Sheff Station submits:In early 2006, Avanir (AVNR) filed a drug application for Zenvia. It had filed a submission for Zenvia with the 30/30 dose combination. Two Phase III studies demonstrated safety and efficacy of Zenvia in PBA as well as 10 clinical trials. Priority review was received from the FDA as they acknowledged it’s a disorder with a high unmet medical need. In late 2006 AVNR received an approvable letter from the FDA.The primary concern of the FDA was QT prolongation. The focus was not on the original therapeutic dose of Zenvia (that included 30mg quinidine) but the thorough QT study where the FDA concentrated on the supratherapeutic dose which was a 60/60 combination. The FDA saw a linear relationship in QT prolongation from the 60/60 combination. As the dose went from 30/30 BID to 60/60 BID there was almost a 2 times increase in QT prolongation. The FDA was concerned that with dosing errors, or drug to drug interactions, that many patients would have the QT risk associated with the 60/60 supratherapeutic dose.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 |
Moving is the Best Medicine. - Video World Arthritis Day on Oct. 12 Calls for Americans to 'Do Blue' and Take Action Against Nation's Most Common Cause of Disability feedproxy.google.com |