TeGenero fiasco prompts regulatory rethink
Article Abstract:
The phase 1 clinical trial of German biotech TeGenerao's monoclonal antibody designed to activate the immune system's T cells has prompted the regulatory authorities to rethink about the adequacy of the preclinical tests that are routinely used during the development of novel biologic drugs. The UK drug regulator, London-based Medicines and Healthcare Products Regulatory Agency (MHRA), has identified the antibody, TGN1412, as being the cause of the life-threatening reactions that occurred in six healthy volunteers, who received the drug on March 13, 2006, at a clinical trials unit.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2006
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Germany reattempts to spark innovation
Article Abstract:
An 'ideas summit' will be convened by Germany's chancellor Gerhard Schroder which will include science and industry leaders as well as government ministers and will concentrate on developing ways to support innovation, which would also be beneficial for the biotech sector. The biotech community has expressed their support for this move but they are not sure whether the government will fulfill its promises regarding supporting innovation.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2004
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Humboldt University beefs up technology transfer
Article Abstract:
Humboldt University, Berlin is the first University in Germany to formalize a patent policy, outlining the rules for technology transfer, revenue sharing, and creation of spin-offs in October 2004. The Humboldt Intellectual Property (IP) policy is designed to use the provision of the new German law that maximizes University's returns.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2004
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