Despite a lift of the ban on biological sample transportation out
of Russia, the country's clinical research industry is still in the
dark on the new rules to control export of such materials.
Diamyd Medical will continue with a clinical trial of its gene
therapy designed to protect insulin-producing cells in diabetes
patients, despite major errors invalidating the study.
Just as the clinical trials sector in Russia is
starting to take off, the industry has been dealt a severe
blow with the sudden and indefinite banning of biological sample
exports.
Veeda Clinical Research, an Anglo-Indian contract research
organisation (CRO) formed two years ago, said it will soon enter
the US market with a new acquisition - the fourth since the
company's creation.
Pfizer is facing fresh legal action from the Nigerian government
over its alleged involvement in the deaths of children it gave
an experimental drug to, more than a decade after the incident
occurred.
MDS Pharma has decided to continue the 'consolidation' of its
Canadian operations by putting an end to some activities at its
Montreal facility, cutting 160 jobs.
The latest ethical reputations of the world's largest
pharmaceutical companies have been revealed, with GlaxoSmithKline
(GSK) emerging as big pharma's Mother Theresa, according to a
recently-released compilation by Geneva-based...
China has today sentenced to death the former director of its State
Food and Drug Administration (SFDA), on charges of corruption,
according to reports in the Chinese media.
US-based contract research organisation (CRO) Covance is offering
microdosing studies for early clinical development without the
perceived drawbacks of having to radiolabel compounds for detection
through ultra-sensitive accelerator...
Clinsys Clinical Research, BioReliance Corporation, InVentiv
Health, PRA International, Kendle, Parexel, PPD, Wyeth and
PharmaNet have all had people on the move in the world of
pharmaceutical outsourcing.
Outsourced pharmaceutical R&D spending is set to increase
at twice the expected rate of general R&D expenditure
for the next five years, according to new research published this
week.
Kendle has climbed back into the black in the first quarter of 2007
after another quarter of strong sales although pre-tax profit
remains down on 2006.
The pharma industry sees great opportunities in using Radio
Frequency Identification (RFID) technology during clinical trials,
a new survey has revealed.
Clinical trial sponsors are outsourcing the majority of clinical
work in Phase I and gradually bringing functions back in-house as
compounds move through the development stages.
Parexel has announced healthy financial results for its third
fiscal quarter, despite another disappointing performance in its
medical communications business.
Contract research organisation (CRO) Chiltern has announced it is
expanding its services with a new solution aimed at helping clients
boost their clinical research staff recruitment process - an
increasingly difficult task due to...
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,...
Clinical trials are saving lives but may be killing the environment
due to their 'intensive energy use' and 'substantial
contribution to greenhouse gasses.'
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.
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...
Indian contract research organisation (CRO) Synchron has acquired
local start-up CRO Innovance - a first-of-its-kind buyout in this
booming area of the pharma market.
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.
The FDA is giving contract research organisations (CROs) the chance
to take part in a pilot designed to test the viability of
electronic case report forms (eCRF).
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...
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.
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.
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.
PDL BioPharma, Synexus, Kendle, PharmaNet Development Group, MDS,
Chiltern International and Laureate Pharma have all had people on
the move in the world of pharmaceutical outsourcing.
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.