TeGenero, maker of the doomed TGN 1412, files for bankruptcy

Get the story here.

Here are some tidbits:

  • The MHRA said that Parexel failed to follow proper procedures (not very good for a CRO who is going to try to run trials for other companies)
  • There was no contract in place at the beginning of the trial (what were they thinking!)

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3 Responses

  1. You should explain who the MHRA are. They are for all intents an purposes a paid branch of the pharmaceutical industry masquarading as part of the UK government. They neatly ignored the fact that they ignored evidence prior to this trial, that they wee responsible for approving the trial protocol.

  2. Helena,

    You are certainly welcome to express your opinions on the MHRA. However, since I don’t have to work closely with the MHRA (and certainly nowhere as closely as I do with the FDA in the US), I don’t really have the background to “explain who the MHRA are.” For purposes of this entry, I regarded them simply as the counterpart to the FDA, basically the regulatory oversight to drug development and registration.

  3. Yes that is who the MHRA they are. Helena is too kind – as the report in this last BMJ neatly describes this is a regulatory problem and a whitewash which is playing itself out over and over again in the UK. Can’t comment on the FDA but I suspect they are part of the same cowboy outfit.

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