The pan-European drug regulator, the European Medicines Agency
(EMEA), has adopted a draft guideline for first-in-man clinical
studies for potential high-risk drugs in a bid to prevent a repeat
of last year's TGN1412 drug trial...
The purchase of Canada's Allied Research International (ARI) has
given Cetero Research a boost to its early-phase clinical services
and geographic reach in Canada.
PharmaNet has been told by the US Securities and Exchange
Commission (SEC) that it will now be the subject of a formal
investigation as it continues to be haunted by the early phase unit
it used to own in Miami.
In anticipation of a new wave of adaptive clinical trials, UK firm
Tessella has designed a software system to help pharma firms
conduct seamless trials that could ultimately save time and money.
A potential new law mandating the running of clinical trials before
a "generic" biologic drug approval may seem like a potential
goldmine for contract research organisations (CROs), however, this
vision is premature.
Legal action could begin today against Parexel if the firm does not
come up with "an adequate proposal" to compensate the victims of
last years drug trial disaster in Northwick Park, London.
GlaxoSmithKline (GSK) has denied allegations that some of its
vaccines have been tested illegally and against good clinical
practice (GCP) in children in Russia.
