Early phase clinical research service provider Altasciences is forming a strategic alliance with ITR Laboratories, a nonclinical services organization, to help more mutual clients customize their drug development programs from lead candidate selection...
The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn, though some are saying that number seems inflated.
California-based Relypsa has entered into a seven-year commercial manufacturing and supply agreement with DSM Fine Chemicals for the API for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. Financial details...
A new report says the Japanese CRO market is seeing more growth as Japanese pharma firms, which traditionally kept research in-house, are now broadening their horizons to use more outsourcing partners.
In an exclusive Q&A, new ACRO Chairman Ciaran Murray says conducting trials in countries such as China and India is critically important for speeding up drug development.
Almac says it is in a unique position to offer Carbon-14 ADME radiolabeling for the growing antibody-drug conjugate (ADC) market and has already performed the service on a Pfizer candidate.
CROs have an important role to play in reducing the number of animals used in drug development and – potentially – much to gain by doing so, according to the European Commission.
Sponsors are piling on more responsibilities for their CRO partners, but the question of how that will translate into increases in risk and profit sharing is a point of contention.
PKPD modelling and simulation is now “ingrained” in drug development and its importance will continue to grow as approaches evolve in “very exciting” coming years, according to an Icon VP.
Charles River Laboratories (CRL) has admitted that areas of overlap created by the WuXi acquisition will lead to a “refinement of certain operating units” but is yet to disclose details.
ACRO is aiming to increase recognition and analysis of the value CROs bring to drug development, spanning their role as strategic partners throughout the process, by funding academic research.
Chiltern has invested in endpoint to establish a strategic relationship which allows it to offer an IRT capable of cutting timelines and costs, a company EVP told Outsourcing-Pharma.
Following a “significant increase in demand” GVK Biosciences has partnered with Quantitative Solutions (QS) to develop and market clinical trial outcome databases, which they believe can improve drug development.
Transcrip Partners’ “augmentation” solution for contract R&D “differs from the normal consultancy alternative by fielding ‘doers’ who can think strategically and ‘thinkers’ who are happy to get their hands dirty” according to senior partner Paul Branthwaite.
The US Food and Drug Administration (FDA) has enhanced its debarment and disqualification procedures to ensure clinical trial investigators meet legal requirements.
An expansion of pilot plant facilities at its operations in Aurangabad, India will help Albany Molecular Research (AMRI) strengthen its position in the Asian drug development sector, according to CEO Thomas D’Ambra.
BioReliance has had to significantly expand its Rockville, US, facility and hire new staff in order to accommodate the growing demand for its genetic toxicology (GeneTox) testing services.
Cambridge Major Laboratories (CML) said it is planning to execute a
$30m expansion project which will spawn one of most modern active
pharmaceutical ingredient (API) manufacturing sites in North
America.
US-based MPI Research and China's Shanghai Medicilon have formed a
joint venture in preclinical services, as they position themselves
to cash in on what is a budding market sector in China.
As pharma firms disclose their financial results for the second
quarter of the year, AstraZeneca (AZ) and Bristol-Myers Squibb
(BMS) have announced more job cuts.
Applied Biosystems (ABI) and MDS Analytical have released a
first-of-its kind mass spectrometry (MS) platform that they claim
will allow the pharmacokinetic analysis of drug libraries 25 times
faster.
Now is an ideal time for small biotechs to ink that perfect deal
with big pharma, attendees heard at the recently held Biotrinity
conference in Oxfordshire, UK.
According to a review of public healthcare funding, the current
method of developing drugs is unsustainable and must be updated if
the UK is to remain at the forefront of European bioscience.
Rising contract research organisation (CRO) and investigator fees
are being blamed in a new report as largely contributing to the
skyrocketing cost of new drugs.
Drug developing services provider Aptuit has acquired the
pharmaceutical services division of technology firm EaglePicher,
enriching its active pharmaceutical ingredient (API) and drug
substance manufacturing offerings.
Several drug development companies are implementing leaner business
models, outsourcing nearly all stages of the drug development
process in response to escalating development costs in a move that
is proving increasingly popular within...
With the cost of drug development expected to reach $1.9bn (€1.5bn)
by 2013, the pressure is on to reduce R&D development time and
cost without sacrificing clinical success rate.
Outsourcing has become so paramount in a pharmaceutical's
infrastructure and drug discovery strategy that it can no longer be
considered an option, according to a Bristol Myers Squibb (BMS)
senior scientist.
Global drug development spending will top $105bn (€81.5bn) by 2010
and 40 per cent of this business is expected to be dished out in
outsourcing contracts - with contract research organisations (CROs)
emerging triumphant.
Quest Pharmaceutical Services (QPS) has announced the launch of its
new Molecular Biology Services that aims to integrate
pharmacogenomics into drug development programs to deliver more
effective compounds to the market quicker.
Thermo Electron has announced the availability of further
enhancements to its Galileo LIMS, which aims to provide additional
capabilities for high throughput ADMET experiments that facilitate
lead optimisation in drug discovery.
Xceleron has given the FDA its seal of approval after the
regulatory body drafted a guidance document that favoured a more
flexible experimental approach to early Phase I clinical studies.
ITI Life Sciences and CXR Biosciences together with Artemis
Pharmaceuticals have entered into a £5.5 million (€7.9 million)
R&D programme to develop new screening and safety models to
more accurately predict the effects of drug...
Computer giant IBM claims to have identified seven key technologies
that will drive innovation in the pharmaceutical industry over the
next decade, raise the quality of development and manufacturing
processes and slash the pre-launch...
The cost and time required to develop a new drug and bring it to
market is determined by the therapeutic category of that drug. The
results are consistent with the model that predicts R&D efforts
are generally shifting toward...
A US programme aimed at shortening the development time for new
pharmaceutical and biological drugs - which involves close
collaboration between the Food and Drug Administration and the
developer - is now underway.
The genomics industry is already separating into two tiers; the
winners are those focused on targets and drug development and which
have products in or near the clinic, as well as strong
partnerships, says analyst
