A new drug class for the treatment of cancer has been hailed as a
breakthrough by researchers in Denmark, who believe that patients
with advanced breast cancer could stand to gain the most benefit
from this new treatment.
Pharma firms may soon have the chance to use US prisoners in
clinical drug trials after a new report by a panel of medical
advisers at the Institute of Medicine recommended government laws
against the practice be loosened.
The use of eClinical software in clinical trials is gaining in
popularity with pharmaceutical, biotechnology and contract research
organizations (CROs), as seen by the recent financial results of
two major industry providers.
Quintiles has turned its latest investment back towards home soil,
announcing plans to open a new US clinical data processing centre
in Williamston, North Carolina.
Outourcing-Pharma focus on: FDA clinical trial initiatives
The US Food and Drug Administration (FDA) has announced a series of
new policy and regulatory developments to modernise the way it
monitors clinical trials and bioresearch.
Outourcing-Pharma focus on: FDA clinical trial initiatives
The US Food and Drug Administration (FDA) has signalled it will
soon allow a new "adaptive" approach to clinical trials in order to
streamline drug testing and speed drugs to market.
Schering-Plough has announced plans to adopt a new global model to
standardise its clinical trial operations throughout the world -
aimed at improving trial consistencies, efficiencies and saving
money.
Outsourcing-Pharma focus: cutting the cost of clinical trials
After recent allegations in the media that poor and illiterate
patients in India are being used, often unknowingly, as human
guinea pigs to test new drugs for the pharma giants of the West,
Outsourcing-Pharma takes a look at how cutting...
The World Health Organization (WHO) has announced details of a new
initiative compelling drug companies to register all clinical
trials on humans after public pressure for more transparency.
According to a new study, efforts to increase R&D pipeline
productivity have never been more aggressive, with clinical
outsourcing being one strategy employed by big pharma to lift
itself out of the doldrums.
Outsourcing-Pharma focus on: cutting the cost of clinical trials
As pharma companies flock towards Eastern Europe and India in a bid
to cut direct clinical trial costs, does outsourcing actually
translate into real world cost-savings?
Medidata Solutions, a global provider of e-clinical data capture,
management and reporting solutions, benefited from the drive from
paper to electronic technology in clinical trials, picking up
several lucrative contracts and expanding...
Datatrak's $18m (€15m) acquisition of ClickFind fulfills the
company's strategy of offering the broadest multi-component
eClinical capability in the clinical trials market.
As China improves its resources and regulatory processes it will
soon become a hotbed of clinical drug research activity, and
position itself as one of the world's most important countries in
this field, according to a new report...
Japanese health care firm Eisai will make Hatfield its European
headquarters, in a major £75 million (€105 million) investment that
demonstrates the UK's appeal for big pharmaceutical companies.
As contract research organisations (CROs) continue to search for
cost-effective countries in which to operate, the clinical trials
market is increasingly expanding into emerging economies. Central
and Eastern Europe are continuing...
Drug companies are leaning more heavily on contract research
organisations (CROs) to save costs in getting new drugs to market.
And it is paying off, with added benefits. Companies who rely on
CROs are also completing clinical trials...
According to a new report, the costs of clinical development are
rising more rapidly in relation to the other parts of the R&D
process, placing greater emphasis on the recruitment of test
subjects, as clinical trial service...
According to a recent report, pharmacogenetics is unlikely to
become a reality within the next 15-20 years having been 'hyped' by
the media, who are unaware of the many gaps in current
understanding of how genetics relates...
Who's making what for whom? In-PharmaTechnologist provides its
periodic round-up of new deals and developments in the
pharmaceutical contract manufacturing sector.
Bayer Healthcare has announced that it will publish information
about its ongoing clinical trials, reinforcing the intention of the
pharmaceutical companies within the industry to provide an arena in
which they can publish information...
Editors of eleven international medical journals have amplified
their call for the registration of drug trials before the first
patient is enrolled,in a medium that is fully searchable and
publicly accessible at no charge.
The European Generic Medicines Association has criticised proposals
by the European Commission to offer six months' additional patent
protection to companies conducting trials of their drug products in
children.
The pharmaceutical industry has announced it would introduce a
central, accessible database to improve the communication of the
clinical study results of marketed drugs.
In an open letter to the British medical Journal, the director of
the UK Cochrane Centre Sir Iain Chalmers has added his voice to
those calling for complete disclosure of clinical trials by
pharmaceutical companies.
Cobra Biomanufacturing has received approval from the UK regulatory
authorities for its new clinical trial manufacturing facilities in
Oxford as well as its established unit in Keele.
The US Food and Drug Administration claims drug companies have
violated government law by failing to disclose the existence of
clinical trials to a government database, writes Wai Lang
Chu.
In the UK, the House of Commons Health Committee is to undertake a
broad-ranging inquiry into the influence of the pharmaceutical
industry on health policy, to look for conflicts between the need
for new drugs and commercial interests,...
Companies developing new drugs for the global market must deal with
the rising costs of the R&D process - and outsourcing may well
be the best route, according to Dr Faiz Kermani, a specialist in
outsourcing and research development.
Industry-backed group says UK should help support the country's
biotech companies by setting up a national agency to organise
clinical trials and boost companies' liquidity.
The number of UK cancer patients taking part in clinical trials has
risen over 70 per cent in recent years, but this trend will be
threatened if the EU adopts its proposals on GCP
Xenova of the UK has been awarded a two-year contract by Sweden's
Pharmexa for the manufacture of a vaccine in clinical trials as a
treatment for breast cancer and other tumours.
