| 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 |
J&J Subsidiary Joins the Diabetes Fray The Burrill Report submits: By Michael FitzhughJohnson & Johnson (JNJ) subsidiary Ortho-McNeil-Janssen has tied up new diabetes drug development deals with Diamyd and Metabolex worth a potential $1 billion combined, adding therapies for both Type 1 and Type 2 diabetes to its pipeline. Complete Story » seekingalpha.com |
Questcor Pharma: Acthar Approval Seems Likely Sheff Station submits:In the second week in May, the Peripheral and Central Nervous System Drugs Advisory Committee to the FDA held a panel meeting to discuss approval for using Questcor’s (QCOR) Acthar in the treatment of infantile spasms. The meeting went very well as the panel's purpose was to advise the FDA on their opinion of whether or not Acthar should be approved by the FDA for this condition. The vote by panel members was overwhelmingly in favor of an approval for Acthar. What this article will do is discuss the breakdown of the voting and give insight on what can be expected from the FDA on September 11th. Since the panel meeting, the original PDUFA date of June 11 was extended to September 11. The FDA is currently reviewing information regarding labeling, REMS and a potential post-approval commitment that they requested from Questcor. If Questcor obtains FDA approval to add IS to the Acthar label in September, then Questcor expects to launch Acthar, for the treatment of IS, during the Child Neurology Society Annual Meeting on October 4th. An approval of their drug would be the first time that they would be able to promote Acthar for the treatment in infantile spasms. With an approved indication, they can target public education efforts regarding the importance of early diagnosis and effective treatment of IS.Complete Story » seekingalpha.com |
Arena's Lorcaserin: Therapeutic Value Zero? No One Of Consequence submits:KLLJ Investments opined in an article here last week that there is zero – not 0.1%, zero – probability that the Food & Drug Administration will reject Arena Pharmaceutical’s (ARNA) lorcaserin drug candidate for weight loss. That’s disturbing. Short-term presentations of lorcaserin efficacy appear to overstate its two-year efficacy, which may exceed its longer efficacy. Therapeutic value of temporary or long-term lorcaserin treatment appears zero, nearly zero, or worse than zero. 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 |