MDS Pharma is continuing its efforts to move on from the trouble
caused in its Pharma Services segment by a US Food and Drug
Administration (FDA) review of its Montreal-area bioanalytical
facilities.
Two French contract research organisations (CROs) that specialise
in ophthalmology have banded together to offer specialised services
to this niche market.
US researchers have developed a fast and inexpensive protein
biomarker detection device that could simplify disease diagnosis
and aid in following disease progression in drug trials.
Eisai is planning to step up its clinical research presence in Asia
and has chosen Singapore as a hub from which to coordinate its
research activities.
As eClinical gathers momentum, Outsourcing-Pharma.com spoke to two
contract research organisations (CROs), Icon and Parexel, to get
their views on the present and future of these emerging
technologies.
New research from Frost & Sullivan provides a snapshot of
biopharma spending trends on contract research organisations
(CROs), along with forecasts for industry growth.
Management of publicly-traded Synexus have agreed to the £18.1m
(€25.7m) sale of the company to a private equity firm that has
promised to fund its global expansion ventures.
This week two sets of contract research organisations (CROs) have
announced plans to link arms in order to spread their reach further
into this increasingly globalised marketplace.
PPD's decision to in-license an investigational compound is proving
to be a drag on its bottom line as the firm continues to seek a
development partner for the drug.
The US Food and Drug Administration (FDA) has slammed
Sanofi-Aventis over its failure to act on known instances of fraud
during clinical trials of its antibiotic Ketek (telithromycin) -
accusations that the firm continues to deny.
Two major bioscience industry trade associations have called for
changes to be made to the European clinical trials directive in
order to bring about "harmonisation, transparency and consistency"
in this area across the...
Parexel has purchased a clinical research organisation (CRO) in
Taiwan as a means to exert its presence in this industry's budding
Asia-Pacific region.
While contract research organisations (CROs) now dominate the
clinical trials market, questions are being raised about the risks
of 'commercialising' clinical studies, according to new research.
The US Food and Drug Administration (FDA) has been called into
question again after the release of a damning report, this time
suggesting the agency is inadequate in its safety monitoring of
clinical trials.
Pfizer will appear this week in a Nigerian court to face
allegations that it caused the death of Nigerian children over a
decade ago when it conducted a clinical trial of its
meningitis drug Trovan (trovafloxacin) in the country.
Californian marketing company BlueLithium has launched a new
web-based solution to help pharma companies overcome the challenges
of recruiting patients for clinical trials.
Pfizer is considering offers from investors in a bid to spin off
its drug research and development laboratory in Japan and make it
an independent entity, according to media reports.
Averion has formed a new partnership in South America's clinical
trial hotspot Brazil - as it continues to tip-toe beyond North
America and Europe into emerging markets.
Two North American contract research organisation (CROs) have this
week announced acquisitive moves into emerging clinical trials
markets, while a third firm has extended an Asian partnership, as
the emerging market migration continues.
'Legislative chaos' has been preventing Poland from reaching its
full potential in the increasingly competitive central Eastern
European (CEE) region, although progress is being made.
etrials and Clinphone, two big players in the eclinical industry
are struggling to keep their heads above water as both companies'
recent woes have impacted their bottom line.
Russian contract research organisation (CRO) Synergy Research Group
has hooked up with a US-based CRO in a bid to expand its services
to North America.
Pfizer, among others, recently offered an insight into R&D
outsourcing in Japan, where this services market is still fairly
immature, with growth potential in several key areas.
Outsourcing-Pharma.com compiles the news that featured in the
clinical contract community this past week, involving Innovaderm
Research, Target Health, Qualia Clinical Service, and Quintiles.
PharmaNet has reported second quarter results that place it back in
the red after it had only just clawed its way back into the black
in the first quarter, following a string of quarterly losses.
PRA said it signed an agreement with equity firm Genstar Capital to
be bought back by the firm for around $790m (€580m) while the CRO
posted a 90 per cent tumble in profit in Q2 due to heavy
restructuring charges.
The total contract research organisation (CRO) market is expected
to reach $24bn (€18bn) by 2010 as biopharma companies' spending on
outsourcing services continues to soar, new research reveals.
Despite the hype, countries in emerging markets are still very much
trailing behind the US in the number of Food and Drug
Administration (FDA)-approved studies being conducted, particularly
the Asia-pacific, a survey by Parexel reveals.
PPD has posted positive financial results for the second quarter of
the year in net contrast to its lacklustre performance in Q1, but
cut its earning outlook for the full year.
Schering-Plough has licensed acadesine (AICA-riboside), a potential
first-in-class drug for the prevention of ischemia-reperfusion
injury from PeriCor Therapeutics to bolster its cardiac
therapeutics pipeline.
Parexel talks to Outsourcing-Pharma about its clinical research
experiences in emerging hot spot Latin America, as the contract
research organisation (CRO) has a presence in every country in this
continent that conducts international...
US researchers have developed a microfluidic device for purifying
and concentrating DNA directly from blood samples that could speed
up the use of genomics in clinical trials.
Quintiles is planning to spend $19m ($14m) to consolidate its US
central lab and its clinical services office in
Georgia to one location and expand capacity at the same
time.
