Genomic Health Announces Results From the Largest Genomic Analysis of Localized Clear Cell Renal Carcinoma at American Society of Clinical Oncology (ASCO) Annual Meeting (PR Newswire)
Genomic Health, Inc. today announced the first results from its collaboration with Pfizer Oncology to study early-stage renal cell carcinoma prognosis, which demonstrated a strong correlation between gene expression and recurrence risk in this patient population. Â The study, which will be presented in an oral presentation tomorrow at the ASCO annual meeting in Chicago, could lead to the development of a multi-gene diagnostic test that estimates the risk of recurrence following surgery and that may ultimately aid in the subsequent identification of early-stage patients with renal cell carcinoma who could benefit most from treatment. us.rd.yahoo.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 |
Life Technologies / Ion Torrent Deal Heats Up Competition in Low-Cost Sequencing
The Burrill Report submits: By Michael FitzhughLife Technologies (LIFE) will pay more than $375 million for the DNA sequencing upstart Ion Torrent, adding new fuel to the ever-heady race to become the life science industry's dominant supplier of low-cost, next-generation sequencers. Complete Story » seekingalpha.com |
Forest Labs Sees Large Call Selling
optionMONSTER submits: By Chris McKhann Forest Laboratories (FRX) has climbed to a new two-year high, but the big trade so far today is someone selling the upside in the pharmaceutical company. Complete Story » seekingalpha.com |
Amgen Scholars Begins Phase 2 - Video
Eight-Year, $34 Million Program, in Partnership with 13 Top Universities, Will Reach Nearly 2,500 Undergraduateshttp://multivu.prnewswire.com/mnr/amgen/47079/ (Photo: http://photos.prnewswire.com/prnh/20101110/MM93873 ) (Photo: http://www.newscom.com/cgi-bin/prnh/20101110/MM93873 ) (Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO ) ( feedproxy.google.com |