An increasing number of factors are luring sponsors to offshore
clinical trials to 'hidden gems' across the globe, delegates heard
at this week's Accelerating Patient Recruitment & Retention in
Clinical Trials conference,...
Drug delivery specialist SCOLR Pharma plans to file a US New Drug
Application (NDA) in the latter half of 2008 for a 12-hour tablet
formulation of the painkiller ibuprofen.
Pro-Pharmaceuticals is preparing to submit a New Drug Application
(NDA) for its lead product candidate, Davanat, as a functional
excipient that promises to hike the efficacy and cut the side
effects of cancer drugs.
Avant Immunotherapeutics will reduce its workforce by a third as
part of a "painful" restructuring aimed at cutting operational
costs, the US-based firm announced this week.
Octagon has bought an electronic data capture (EDC) company and is
now claiming to be the first company to address the process problem
in clinical R&D by offering "an end-to-end solution that
crosses traditional functional...
Most clinical trial sites are utterly unprepared in the face of a
natural disaster and are paying a heavy price if they are unlucky
enough to be affected, delegates heard at last week's Drug
Information Association (DIA) conference...
Insurance firm Darwin is targeting the booming contract research
organisation (CRO) market by launching its own insurance cover
designed specifically for companies or organisations involved in
clinical research.
INC Research has become the latest contract research organisation
(CRO) to dive into India, whilst Pharmaceutical Products
Development (PPD) has opened offices in Athens and Seattle.
Japan is getting serious about clinical trial reform after years of
lagging behind the rest of the developed world in the availability
of drugs in the country, which ironically is the world's number two
pharma market behind the...
Three doctors from a Russian hospital hired to run clinical trials
for GlaxoSmithKline (GSK) have now been charged by local
prosecutors over alleged illegal practices during the study on
children.
Medifacts International has sold its contract research organisation
(CRO) unit after a reorganisation sparked by the firm's filing for
Chapter 11 bankruptcy protection in February.
A drug discovery collaboration between Ranbaxy and GlaxoSmithKline
(GSK) is bearing fruit with the companies stepping up their
respiratory inflammation research.
Covance is seeing the high potential of the booming market for
biomarkers and has decided to devote an entire expert team to
support clients with biomarker-related services.
A next-generation insomnia drug has been put to bed after its
developers decided the risk of using the drug outweighed its
potential benefit to millions of insomnia sufferers.
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...
Contract research organisation (CRO) Charles River Laboratories has
announced it will establish a presence in China by signing a joint
venture deal with Shanghai BioExplorer, a Chinese preclinical
services provider.
A new wave of drugs designed to treat rare brain disorders, which
are caused when proteins don't fold correctly, are showing
promising results in trials, according to their developer.
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.
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.
A new report has been released this week calling for reforms in
first-in-man clinical trials in the wake of the TGN1412 drug trial
disaster in London last year.
GlaxoSmithKline (GSK) has denied allegations that some of its
vaccines have been tested illegally and against good clinical
practice (GCP) in children in Russia.
A highly-acquisitive and research-intensive year has left drug
discovery services provider Galapagos further in the red at the end
of its 2006 financial year, although sales soared.
India's budget finance minister has today announced a tax exemption
on all services carried out by its contract research and clinical
trials industry – a saving of 12.24 per cent.
A host of budding drug discovery firms were bestowed with
recognition for their performances during a recently-held 2006
Frost & Sullivan European Healthcare awards ceremony.
The Ketek saga continues as a former employee of Pharmaceutical
Product Development (PPD) has claimed that Aventis and PPD – the
contract research organisation (CRO) hired by the firm – were both
aware of fraudulent data in a clinical...
A new start up company in the UK has been formed with ambitions to
shape itself into a global early-phase drug development services
group through an acquisition-based strategy.
US outsourcing company Covance has announced it is to open a
central laboratory in China in order to meet the growing demand for
clinical trials conducted in the region and has expanded its
capabilities in Texas.
As SR Pharma and Quark Biotech start clinical trials of a drug that
uses a Nobel Prize winning technique to 'silence' disease-causing
genes, the largest pharma firms are keen to grab a piece of the
action.
Bridge Pharmaceuticals has just launched a new training scheme
between its facilities in the US and China to enable its employees
to cross train in both labs - a potential competitive advantage for
a contract research organisation...
Parexel has announced encouraging financial results for its second
fiscal quarter, despite 'disappointing' performance in its medical
communications business.
UK biotech company Verona Pharma has contracted fellow UK firm Onyx
to manufacture supplies of its new hay fever drug candidate for
forthcoming preclinical and clinical studies.
PRA International has entered into an alliance with US Oncology
Research, designed to accelerate the clinical development of new
cancer treatments in the US.
Scientists have revealed a possible reason why the Northwick Park
clinical trial of a drug designed to stimulate the immune system
instead led to multiple organ failure in the human volunteers.
Canadian contract manufacturer QSV Biologics has signed two
manufacturing deals in as many weeks, strengthening its position in
the Phase II and III clinical supplies arena.
Charles River Laboratories confirmed it is persevering in its
intention to focus on its preclinical and Phase I businesses while
abandoning its late stage development services, during a conference
earlier this month.
There are currently three key market trends that play to Parexel's
strengths and one of them is the globalisation of clinical trials,
the company's CEO claimed during a healthcare conference earlier
this month.
Covance was nothing but optimistic about the future of contract
research organisations (CROs) during a JPMorgan healthcare
conference held last week, despite a slowdown in R&D spending
over the past year.
A new study condemns the high prevalence of ghost writing in
pharmaceutical company-sponsored clinical trials and calls for the
controversial practice to be culled in order to improve
transparency.
Quintiles has teamed up with practices group Onmark to create a
national clinical trial network comprised of Onmark members - a
move that could help the CRO cope with increasing patient
recruitment issues in the US.