Ireland's Almac Group has announced the creation of a new oncology
division that will focus on the discovery and development of "novel
and innovative" approaches to treatment in this key disease area.
Cordium Links has partnered with an unnamed Chinese firm to bring
electrocardiogram (ECG) laboratory services to companies performing
cardiac safety evaluation as part of clinical research in China -
claiming to be the first firm...
Introgen Therapeutics says advances in its biologics manufacturing
and storage technologies have allowed it to broaden the scope of
its contract manufacturing operations and set up a new unit called
Introgen Technical Services (ITS).
Sartorius Stedim Biotech has teamed up with Wuxi AppTec to help
companies remove some of the strain of carrying out viral clearance
testing, which for large biopharmaceutical companies can carry a
price tag of up to $1m a year.
West Analytical Services says it has introduced a testing platform
to help customers testing pulmonary and nasal drug products and
their delivery devices.
MDS Pharma Services has expanded its portfolio of bioanalytical
testing services with the addition of electrochemiluminescent assay
(ECLA) capability, used to test biological samples from clinical
research participants.
China's Wuxi PharmaTech saw revenues race away across its divisions
in the first quarter of 2008, benefitting from the continued shift
towards outsourcing of manufacturing and laboratory functions by
the pharmaceutical industry.
The US Food and Drug Administration has declared the country's
previously-tainted heparin supply to be "safe" due to
stronger testing and controls that are now in place. Meanwhile,
China continues to distance itself...
AMRI witnessed strong growth in two of its contract business during
the first quarter of 2008 although profit was impacted by its
dominant large-scale division, which lagged during the period.
UK-based Cambridge Consultants has developed a portable instrument
which it says could "revolutionise" the way airborne drug
delivery devices are tested.
Overall, 2007 was another stellar year for contract service
providers, particularly those at the early-stage end of
development, although companies are advised to watch out for a
tougher environment ahead.
The number of people whose deaths are associated with an allergic
reaction to heparin has shot up as the US Food and Drug
Administration (FDA) has updated its tally.
Quintiles has forged a new partnership that will allow it to begin
providing central laboratory services in Japan, where the clinical
research organisation (CRO) industry is gaining momentum.
Jubilant Organosys, India's largest custom research and
manufacturing services (CRAMS) provider, has scored new contracts
to the tune of $92m for the year thus far as its business continues
to gather momentum.
An investigation in the aftermath of a fire and explosion at one of
Cambrex' US plants last year has found the firm in breach of
several safety regulations and the company will be fined
accordingly.
Four of India's biggest vaccine manufacturers have had their
licenses suspended by the Indian government after failing to meet
good manufacturing practise (GMP) requirements, according to local
media reports.
Pfizer Japan is cleaning out its closet, selling a range of its
"surplus" biotech and pharmaceutical lab equipment via an online
auction, a method that is slowly catching on in the country.
Product recalls in the UK due to health and safety concerns have
shot up to their highest level, with the rise in outsourcing to
China finger pointed for much of the blame.
Although India 'has carved out a significant portion of the world
pharma pie', an enormous change in mindset is needed if the country
is to become a global pharmaceutical hub, according to a new report
from KPMG.
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.
The first steps in tightening the safety controls on the
pharmaceutical ingredients imported to the US from China have been
taken following months of negotiations between the regulatory
bodies of the two countries.
GVK Bio has reinforced its claim to be India's top contract
research organisation with a 100-crore ($25m) push from a private
investment company. The funds will be used to expand its drug
discovery services and push further into...
As of next year Chinese pharmaceutical manufacturers will face a
tougher time gaining good manufacturing practice (GMP)
certification after the country's regulator signalled new and
stricter standards were on the way.
A new report highlights a number of worrying trends emerging in
regard to the increasing number of fake pharmaceuticals
infiltrating supply chains around the globe.
Sigma-Aldrich continued its strong year with both revenues and
pre-tax profits showing strong double-digit growth in the third
quarter predicting it will break the $2bn (€1.4bn) revenue mark
this year.
It seems that the ghost of the US Food and Drug Administration
(FDA) probe has stopped haunting MDS Pharma as the firm posted
encouraging financial results in the third quarter.
The US Food and Drug Administration (FDA) is following the growing
pharma industry trend by embracing outsourcing as part of a
cost-saving drive - a move that is attracting strong opposition.
PerkinElmer has expanded its multi-vendor service offering to help
firms reduce the cost of regulatory compliance in pharmaceutical
drug development and manufacturing quality control laboratories.
China has announced an initial $1.7bn investment to bolster its
currently questionable ability to effectively monitor the quality
of the food and drugs manufactured within its borders.
The US Food and Drug Administration (FDA) has released a draft
guideline document outlining a model for implementing the
International Conference on Harmonization's (ICH) Q10.
As Outsourcing-Pharma.com continues to investigate the
circumstances of the Inyx group's insolvency problems, it can
be revealed that some of the senior management have been
involved at a senior level in other firms that have...
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.
The pharmaceutical and healthcare industries will help to push
trade between India and the United Kingdom up by 60 per cent within
three years, claims a soon-to-be released report.
An online database detailing information on all manufacturing and
importation certificates and authorisations issued within the
European medicines network has been launched by the European
Medicines Agency (EMEA).
Charles River Laboratories' portable endotoxin testing system, the
Endosafe PTS, has been successfully used to detect bacteria on the
International Space Station (ISS).
Pharmatek has moved to a new larger lab and manufacturing facility
while Pace Analytical Life Sciences recently acquired lab testing
firm P3 Scientific.
the exponential growth of data points flowing into clinical study databases. As technologies help researchers to reach more patients all over the world,...
Solvents are defined as organic chemicals that are used to dissolve components. They are used during the manufacture of drug substances and can also potentially...
