Medidata Solutions has opened a new clinical data centre and
enlisted the help of consultancy firm C3i to provide its customers
with faster and more secure electronic clinical trial support as
demand for these services continues to...
The University of Kentucky has unveiled the state's largest sterile
pharmaceutical manufacturing site which is unique among others
worldwide as it is the first to produce cytotoxic and non-cytotoxic
drugs in the same room at...
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.
US biotech company Spherix has selected Singapore-based clinical
research organisation (CRO) Gleneagles to take charge of the Phase
III clinical trial program for its new Type 2 diabetes drug,
Naturlose.
Kendle has seized a chance to expand and diversify its business,
snapping up the Phase II-IV Clinical Services unit of Charles River
Laboratories after it decided to get out of this area of clinical
trial services and focus instead...
The World Health Organisation is calling for greater transparency
in clinical trials by announcing new registration standards for all
medical research involving humans.
Covance has stepped up its laboratory testing capabilities in the
Asia Pacific region to satisfy the growing number of sponsors
conducting clinical studies in this budding location.
PRA International has bought its first company in India - contract
research organisation (CRO) Sterling Synergy Systems - joining the
growing list of top CROs who have set up operations in this fertile
market.
A new initiative that could see the world's major pharmaceutical
and biotechnology companies team up with a major cancer
organisation to research and develop new anti-cancer drugs has been
unveiled.
PPD has announced it has signed an agreement with PDL BioPharma in
which the contract research organisation is to perform
comprehensive molecular profiling to discover biomarkers.
Outsourcing-Pharma focus on: Phase IIIB-IV research
The US Food & Drug Administration's (FDA) drive to clear the
mounting backlog of post-marketing (Phase IV) drug trials signals
good news for the clinical research organisations (CROs) who are
poised to benefit.
Outsourcing-Pharma focus on: Phase IIIB-IV research
The US Food & Drug Administration (FDA) is investigating ways
of boosting the completion rate of new drug post marketing
commitment studies in the wake of ongoing controversy over the
agency's lack of enforcement. The answer,...
Bespak is now ramping up manufacturing of Chiesi Farmaceutici's new
dry powder inhaler (DPI), in preparation for clinical trials of the
device in patients with asthma and COPD (chronic obstructive
pulmonary disease).
American Peptide Company (APC) has entered into a manufacturing
agreement with Affymax for the clinical supply of the first in its
pipeline of peptide-based drugs.
A new interactive voice response (IVR) package is available for
small clinical trials, aimed at companies who previously found this
technology unaffordable.
Ablynx and Procter and Gamble have announced the extension of its
Nanobody drug discovery and development agreement to metabolic
targets in a move that reinforces the feeling within the industry
regarding Nanobody technology and its...
The growth spurt continues for Icon Clinical Research as it opens
up a new office in Milan, Italy, following a recent acquisition and
two new global contracts.
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?
According to a new report, the pharmaceutical market grew seven per
cent, to $602 billion (€501 billion) in 2005. The report
highlighted the emerging markets including China, Korea, Mexico,
Russia and Turkey, which experienced double-digit...
Laureate Pharma, a full service biopharmaceutical development and
protein production company, has been given a new contract by
Bradmer Pharmaceuticals to develop and manufacture its novel brain
cancer treatment for Phase III clinical...
Outsourcing-Pharma Focus: Cutting the cost of clinical trials
Patient recruitment consumes more time than any other clinical
trial activity, costing the industry millions of dollars. However,
recruiting patients on the Internet can slash recruitment times and
bring drugs to market faster.
The drug trial catastrophe, which has endangered the lives of six
male volunteers of which two are still in a coma, could've been
avoided after a similar study conducted last year yielded similar
side effects.
Bayer Healthcare has selected Genedata's Bioinformatic platform for
its target research and biomarker activities in which the deal will
involve the mechanistic analysis of cardiovascular and cancer
biomarker genes.
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...
Parexel, one of the world's leading clinical research organisations
is under investigation after six men in a UK drug trial being run
by the company were admitted to intensive care on Tuesday.
Phoenix Data Systems has recently launched an interactive voice
response (IVR) system and a range of new services to accompany its
current electronic data capture (EDC) technology.
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.
Its upcoming inhalable insulin drug may prove a blockbuster but
Nektar's 2005 results brought the biopharmaceutical company further
in the red, with a net loss of $108.2m (€91m) in Q4 more than five
times higher than the $19.3m...
Perceptive Informatics, a subsidiary of Parexel, has released the
latest version of its web interface for data capture, patient
randomisation and the management of study drug inventory for
clinical trials.
In order to stay competitive, Wyeth looks to model its business not
on that of other pharma companies, but of other successful big
industries, which includes outsourcing or off-shoring anything that
is not a core function.
According to a new report, the adoption of eClinical technologies
has been hampered by the ability to take the electronic revolution
to the next level, as the adoption of eClinical technologies
currently remain confined to localised...
Chiltern is expanding its clinical trial services business in
India, and in doing so will be the first company to provide
specialised staff recruitment services for the Indian clinical
research industry.
Contract Research Organisation (CRO) Averion, and the SIPLAS
Research Organisation has signed an agreement to provide promotion
and support of clinical trials in a move that that reinforces Latin
America as an emerging hub of clinical...
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...
Outsourcing-Pharma: Focus on Phase IIIB-IV research
A new book is available to help those involved in designing and
conducting Phase IIIB and IV research gain maximum return on
investment and deal effectively with post-marketing safety issues.
Outsourcing-Pharma: Focus on Phase IIIB-IV research
The spate of recent high-profile drug recalls, culminating in the
dramatic high profile withdrawal of Vioxx in 2004, has fuelled a
trend of consolidation within the Phase IIIB-IV clinical trials
outsourcing sector that looks set to...
Outsourcing-Pharma: Focus on Phase IIIB-IV research
Phase IIIB-IV clinical research in the US is now booming, growing
20 per cent annually, compared with only 7 per cent for Phase
II-III research, driven by a surge in public drug safety concerns
and increased drug market competitiveness.
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...
The big pharma companies may have dreamed of launching the world's
first non-injectable insulin, but it has been Canadian biotech
company Generex that shattered this dream, bypassing EU and US
regulatory processes and launching...
With the first non-injectable insulin to the world market predicted
to earn $1.5 bn (€1.2 bn) a year, inhaled pulmonary delivery is
winning the race, looking certain to trigger a bitter grapple
between the big insulin players.
ImmuPharma, a drug discovery and development company, are to seek
admission to the Alternative Investments Market (AIM), in a move
that will give the group the resources necessary to finance initial
clinical trials on ImmuPharma's...
DataLabs has launched the first software to combine paper data
entry (PDE) and electronic data capture (EDC) in the one program to
accelerate the clinical trials process.
Phase IV clinical trials are becoming key activities for
cardiovascular marketing teams who are increasingly using them to
rejuvenate ageing medications and improve marketing campaigns.
A new report reveals that a lack of validation amongst drug
discovery processes has emerged as a major restraint to the uptake
and penetration levels of computational biology tools in the drug
discovery industry.
Hill Top Research, one of the leading clinical research services
companies in the US, has positioned itself for growth after last
week's acquisition by Utah's DW Healthcare Partners, a private
equity firm focused on the...
Indian IT company Tata Consultancy Services (TCS) has scored a
contract from Danish pharma company Novo Nordisk for the data
management of its clinical trials run in India.
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...
Leading contract research organisation, Covance, has upgraded its
software to streamline the laboratory testing aspect of its
clinical trials and allow sponsoring drug companies greater
involvement in the overall process.
