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Biogen Idec Inc. Message Board

  • berblady berblady Dec 1, 1998 10:15 AM Flag

    Re-labeling Rituxan?

    A story in today's Health News Daily. Roche is
    strengthening warnings in European labeling of Rituximab
    because of 8 fatal cases of severe cytokine release
    syndrome. IDEC and Genentech are discussing Rituxan
    labeling revisions with the FDA.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • If I were Idec I wouldn't give an inch either. I
      doubt the same holds true for Genentech or Hoffman.
      Let's face it. 10-12 thousand doses of Rituxan have
      been given and we are NOT hearing about all kinds of
      cures. Now we hear Rituxan has triggered some deaths. I
      can understand how a massive dose of anything can
      imbalance a sytem but they are saying some deaths are due
      to offlabel use. Doesn't that mean the intermediate
      and higher grades of NHL, or 2/3 of the new cases?
      Why haven't we heard anything about these 60-70 other
      trials, the ones in the higher grades? Idec has never
      been short of good news rumors. Where are they? Maybr
      they'll give us some answers at the upcoming AS of H
      meeting. It was a war between Rastetter and Bigham (CLTR)
      last year. IDPH has been good to me, I've been long
      since 1995, but I'm not about to put on blinders.

    • Partner, never. IDEC right now stands on their
      own, why buy partners? And why does TCLN have
      intermediate and high grade non-Hodkins lymphoma to
      themselves? Is Oncloym 1 that good? Nah, just hype. Hopefully
      their human trials on their other technologies isn't
      competition. I meant they might be worth buying for short
      term, they won't ever get to 30 bucks a share.


      rppul

    • Or maybe a partner, it depends on who they
      license to. They seem to have intermediate and high grade
      non-Hodgkins lymphoma to themselves. They haven't said a word
      about their phase 3 but we didn't either during
      ours.

      I think Coulter is a bunch of hypesters with a lot
      of cash. How can they expect to get FDA approval
      based on one trial of 60 people when only 32 are
      evaluable? Get real! Between Idec and Techniclone there
      isn't much NHL left for them to treat.

    • Techniclone will be presenting there as well, if we are speaking of the same as well as two other, and this could help begin to shed light on this little company. Success to all.

      rppul

    • from her morning notes...."the emea announced
      rec. for use of rituxan, due to rare severe but easily
      preventable advers reactions, which resulted in 8 deaths,
      some in patients that were treated off label, among
      the 12,000-14,000pts treated to
      date........pre-treatment with anti-histamines and corticosteroids can
      prevent /minimize the reaction and is currently in the us
      rituxan product label. we expect a dear dr letter
      shortly, but do not anticipate any impact on drug
      use...""

      " the rxn tumor lysis syndrome , results from the
      drug's extreme efficacy in killing tumor cells.." bottom
      line is this is an over-reaction....she re-recommended
      her buy with a $50 target...and eps for 98 of .72 99
      eps .89 00 eps $1.25

 
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