ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
www.ahrp.org
FYI
BBC reports:
"TeGenero, a German pharmaceutical company, said it could not continue in
business.Because of the fallout from the UK trial, it was impossible to
attract
investment, TeGenero said."
The British MHRA (equivalent to the U.S. FDA) reportedly acknowledged that
Parexel, the U.S. firm that conducted the catastrophic experiment in London
on six healthy volunteers,
"failed to follow proper procedures."
Contact: Vera Hassner Sharav
212-595-8974
[email protected]
BBC NEWS
Tuesday, 4 July 2006, 15:30 GMT 16:30 UK
Drug maker files for insolvency
http://news.bbc.co.uk/2/low/health/5146692.stm
The German firm that produced a drug at the heart of a disastrous
clinical trial that left six men seriously ill has declared itself
insolvent.
TeGenero, a German pharmaceutical company, said it could not continue in
business.
Because of the fallout from the UK trial, it was impossible to attract
investment, TeGenero said.
Claims for compensation arising from the trial will continue to be
handled by TeGenero's insurers.
Parexel, a clinical research organisation, carried out the trial on
behalf of TeGenero.
Six previously healthy men who took part in the trial of the drug,
TGN1412, suffered multiple organ failure.
The Medicines and Healthcare products Regulatory Authority (MHRA) said
Parexel failed to follow proper procedures.
It found there was also no contract in place between TeGenero, the
makers of the drug, and Parexel at the beginning of the trial.
TeGenero has maintained that the men's reactions were "completely
unexpected" and did not reflect the results obtained from the earlier
laboratory studies.
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