Skip ads and navigation
Advertising
Our network sites seattlepi.comHelp
The Life Sciences Blog
Print thisE-mail this
Mid-day round-up: OncoGenex, Amgen

  • Amgen said this morning that Nplate, its treatment for Idiopathic thrombocytopenic purpura, a rare bleeding disorder, has been approved by the FDA. Read a release here. The approval was expected, although last month Amgen said the FDA's decision had been delayed.

  • On its second day as a new company, OncoGenex Pharmaceuticals said the FDA had granted it fast-track designation for OGX-011, which is in five phase two clinical studies in prostate, lung and breast cancer. The FDA says the "designation is intended for the combination of a product and a claim that addresses an unmet medical need." Among the benefits: "scheduled meetings to seek FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints." OncoGenex is planning a phase three study of OGX-011.

    • Posted by at August 22, 2008 11:45 a.m.
    Categories: ,
    Comments
    There are currently no comments for this blog entry.

    ! Login below to post a comment.

    Registered users, log in here
    E-mail 
    Password 
    Remember me
     HELP! I forget my password

    Unregistered users, sign up now

    Or post anonymously (About this feature)

    Your comment (No HTML allowed, use these special codes instead)
    Violating our Terms of Service may result in your post being removed.

    Special codes
    • [b]selected text[/b] -- Display the selected text in bold.
    • [i]selected text[/i] -- Display the selected text in italics.
    • [link]www.seattlepi.com[/link] -- Creates a link to the url between the link tags.
    • [link title="Seattle Post-Intelligencer"]www.seattlepi.com[/link] -- Creates a link to the url between the link tags, uses title as link text.
    • [mail]newmedia@seattlepi.com[/mail] -- Creates a link to an email address.
    Enter the code shown:
    What is this?
    SUBSCRIBE

    RSS
    Headline widget

    BLOGGER BIO
    photo
    Joe Tartakoff: P-I staff reporter
    CONTACT INFO

    News tips or comments? E-mail me or call directly, 206-448-8293.

    TOP OF THE BLOG

    Most popular posts in July, by page views
    1. Dendreon initiates new Provenge study
    2. Allen Institute releases spinal cord map
    3. Genentech, Roche – and Seattle Genetics

    Q & As

    Excerpts from interviews
    · Don Foster on Novo Nordisk
    · Bruce Carter on ZymoGenetics
    · Lee Huntsman on the Life Sciences Discovery Fund
    · Clay Siegall on Seattle Genetics
    · J. Michael French on MDRNA
    · Jack Faris on the WBBA

    THE INFLUENTIAL

    A series on the blog taking stock of Seattle's biotech leaders
    · Who are Seattle's most influential biotech leaders?
    · The CEO: Bruce Carter
    · The entrepreneur: Bruce Montgomery
    · The investor: Alan Frazier
    · Your choices

    THE STATE OF BIOTECH

    A series on the blog
    · Seattle's contracting biotech job market
    · Venture capital numbers here don't measure up
    · A fall in the market value of local firms

    ARCHIVES
    Search this blog

    Recent entries
    · Stories to watch: ZGEN and SGEN
    · Round-up: Dendreon, SonoSite
    · Stories to watch: Provenge
    · Stories to watch: Amgen's Elliott Bay plans
    · Round-up: Cell Therapeutics, Amgen

    Browse by month
    Browse by category

    RSS/Web feeds (help)
    RSS 2.0RSS 1.0Atom
    Headlines for your site

    LINKS

    Blogs
    · Pharmalot
    · John Cook's Venture Blog
    · blog.bioethics.net
    · Eye on FDA
    · In the Pipeline
    · IN VIVO Blog
    · The Biotech Weblog
    · DrugWonks
    · Biotech Blog
    · BioHealth Investor
    · Xconomy Seattle
    · Andy's Take

    Groups
    · Washington Biotechnology and Biomedical Association
    · Northwest Association for Biomedical Research

    Rumors
    · Biofind

    Jobs
    · WBBA Careers
    · Medzilla
    · BioJobBlog

    Resources
    · Clinicaltrials.gov

    Most recent posts
    · Huskies Football: Third quarter notes (updated throughout)
    · Film Hound: Slothful Saturday
    · Huskies Football: Second quarter notes

    *Would you like to blog for us?

    ADVERTISING
    AP BUSINESS HEADLINES
    · Consumers a reluctant bunch at LA Auto Show
    · Investor fear remains deep despite 1-day rally
    · APEC leaders endorse ban on protectionist measures
    · Hollywood actors guild to seek strike
    · White House: Meeting set on North Korean nukes
    *more
    AP HIGH-TECH HEADLINES
    · Web sites offer real estate agent rankings
    · Pentagon bans computer flash drives
    · Vloggers and stars alike gather for YouTube Live
    · Bug-sized spies: US develops tiny flying robots
    · Engineers sentenced to 1 year for espionage case
    *more
    Advertising

    Seattle Post-Intelligencer
    101 Elliott Ave. W.
    Seattle, WA 98119
    (206) 448-8000

    Home Delivery: (206) 464-2121 or (800) 542-0820
    seattlepi.com serves about 1.7 million unique visitors
    and 30 million page views each month.

    Send comments to newmedia@seattlepi.com
    Send investigative tips to iteam@seattlepi.com
    ©1996-2007 Seattle Post-Intelligencer
    Terms of Use/Privacy Policy

    Hearst Newspapers