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Kendle International posted a 22 per cent drop in net income to $5m, after a computer error led to problems with a clinical trial carried out for one of its customers.
Contract research firm Icon Clinical saw its revenues advance by nearly 22 per cent in the last quarter of 2008, but still saw its share price slide as investors got the jitters over the firm’s cautious predictions for 2009.
It is not compulsory to respond to form 483s detailing deficiencies at a facility but the FDAs latest guidance fully recommends companies do so to avoid being issued with a warning letter.
Synexus' new trial site in Bulgaria, which is part of the firm’s clinical research centre strategy, will help sponsors cut development times and significantly reduce costs, according to CEO Michael Fort.
Central African countries have formed a network to promote excellence in clinical trials in the region, with €3m of EU funding being used to improve HIV, malaria and tuberculosis research.
Stemedica Cell Technologies is seeking approval from the California Department of Health to begin the production of adult stem cells for Phase I and II clinical trials at its facility in San Diego, US.
Outsourcing-Pharma.com presents its periodic round-up of executive appointments in the contract services sector.
Expansion of Frontage’s collaboration with Beijing Second Pharmaceuticals will give it a new 1,800 sq m R&D centre and further increase its presence in China.
UK contract services provider Melbourn Scientific has extended its service portfolio, predicting that demand for outsourced early R&D will increase in times of economic gloom.
The proposed FDA funding for 2009 has given a boost to the agency, with $300m more being offered than the agency requested to ensure the safety of products.
TGaS Advisors' vice president Gary McWalters believes the drug industry must rethink its approach to regulatory compliance and how it works with healthcare professionals.
The US subsidiary of world leading generics firm Teva Pharmaceutical Industries has called in procurement specialist ICG Commerce to help it cut its outsourcing spend as part of ongoing cost reduction operations.
Overcapacity in pharmaceutical manufacturing around the world means that smaller drugmakers sometimes set themselves up as contract manufacturers in order to provide an additional revenue stream and avoid standing plants idle.
Contract research and instrument company Bioanalytical Systems Inc (BASi) saw a dramatic decline in service revenues in the last quarter of 2008 on the back of its exit from the Phase I clinical trials business.
Canada’s Dalton Pharma Services has had its chemistry services contract with Boehringer Ingelheim renewed.
Patheon says the $183m (€142m) buy-out proposal by private equity group JLL Patheon Holdings is “opportunistic” and designed to take advantage of the recent stock-market related fluctuation in its valuation.
The issue of transparency in clinical research has raised its head again with a new study suggesting the results of Phase I trials are less likely to be published compared to other types of studies.
Numerous members of IRBs have conflicts of interest, lack the necessary expertise and fail to follow HHS regulations, according to the OHRP.
PII has expanded the range of drug delivery solutions it can offer clients through collaboration with NexMed, which gives the contract formulation company access to transdermal technology.
Despite going through a difficult period PharmaNet is continuing to expand through the opening of another office in Latin America, which reinforces its commitment to the region.
Study site operators want greater use of EDC technologies and more pharma industry investment to boost patient recruitment and reduce delays in clinical trials, according to an industry report due to be published next week.
Two UK-based companies, PRECOS and Argenta Discovery, have pooled their resources in the area of cancer drug discovery to provide services spanning “from hit finding to in vivo proof-of-concept.”
Alamac Clinical Services (ACS) has added a new cold-chain and supply storage facility at its site in Craigavon, Northern Ireland in response to what it describes as an “unprecedented increase in demand” from drug industry clients.
UK company Celsis saw softness in demand across its operating divisions in the third quarter ended December 31, and said it was considering “strategic alternatives” for its laboratory services unit.
Contract research organisation Bio-Imaging Technologies posted a 48 per cent hike on revenues in the fourth quarter of 2008, but still made a small net loss on the back of its CapMed division, which was sold last month.
Valois Pharma is installing precision plastic molding capabilities at its manufacturing facility in Congers, New York, US as part of ongoing efforts to modernise its global manufacturing operations.
WIL Research Laboratories has expanded into protein and small molecule bioanalysis and genetic toxicology through the acquisition of Midwest BioResearch.
AstraZeneca has installed a customised version of Cytel’s East clinical trial design software, which the pharma giant is using to increase the efficiency and security of its clinical trials.
Drug delivery company OctoPlus has signed a new contract with fellow Dutch company Galapagos that it says will “significantly contribute” to its revenues.
Albany Molecular Research Inc (AMRI) faced a “challenging headwind” as 2008 drew to a close but still managed to boost its revenues by 19 per cent to $56.4m in the fourth quarter of 2008.
US CRO staffing and functional specialist ASG has purchased contract research firm Ockham, furthering its evolution into a one-stop clinical contracting firm.
US firm Expression Analysis has teamed up with Complement Genomics of the UK to combine their genetic testing service offerings.
eClinical specialist Phase Forward saw revenues top guidance with a 28 per cent increase to $48m in the fourth quarter of 2008, driven by growth in its InForm electronic data capture (EDC) system.
US software specialist etrials Worldwide has added Belgian rival Unithink to an ongoing lawsuit that accuses two former executives, Robert Sammis and Brendon Ball, of breaching confidentiality agreements.
A study is predicting biologics will drive contract manufacturing to new heights, with Gilead Sciences reported to be the latest biotech to pursue production partnerships in India.
Outsourcing-pharma spoke to Amcor Flexibles about the future of the global flexible packaging market.
Gene Logic has purchased an Illumina iScan for use with high density Infinium HD assays, which should allow it to expand its genotyping services.
TGaS Advisors has launched a new version of its commercial compliance benchmark (CCB), which aims to help companies adhere to the array of guidance affecting their operations.
Charles River Laboratories will reduce its workforce by 3 per cent, close its preclinical facility in Arkansas, US and sell off its Phase I trial site in Edinburgh, Scotland as part of a cost reduction programme.
Norwich Pharmaceuticals is expanding beyond its core business to offer clients help throughout a product’s lifecycle, covering exploring new product categories to replacing inefficient suppliers.
A paediatric research coalition has been launched in Belgium, bringing together CROs, pharma companies and paediatricians to further knowledge.
MD Logistics has added a 15,000 sq ft of cold-storage facility to its distribution operations in Indiana, US in response to the rising demand for biologics transportation services.
Compass Pharma Services is targeting contract drug developers and clinical research firms with a new microfilling offering that, it claims, helps reduce waste and may even make excipients unnecessary in some drugs.
The Malaysian Biotechnology Corporation (BiotechCorp) is continuing to forge allegiances with Indian companies in an attempt to become a biotech and outsourcing hub.
Image Solutions is offering a service to help Spanish life science companies make the transition to using electronic regulatory submissions.
Seattle, US-based Cell Therapeutics Inc is looking at ways to reduce its involvement in a preclinical research facility based in Bresso, Italy, as it tries to cut costs.
Canadian non-clinical contract research organisation (CRO) LAB Research is predicting that it will slide into a net loss in the fourth quarter of 2008 as it copes with a series of study delays.
PPD has reached an agreement to buy AbCRO, which it hopes will strengthen its position in the thriving Central and Eastern European (CEE) clinical trials scene.
Pfizer has preempted the Sunshine Act by promising to disclose payments made to principal investigators, major academic institutions and research sites involved in Phase I to IV trials.
PacificGMP has signed an agreement to provide storage services under current good manufacturing practices (cGMP) standards for LigoCyte's norovirus vaccine programme.
Russia approved 615 clinical trials last year, a 9 per cent increase over 2007, lending weight to the notion that the country is becoming a global hub for clinical testing.
Northern Ireland-based contractor Almac will add 25 new staff at its facility in Craigavon before the end of the month, continuing its policy of recruiting local science talent.
Commercial services firm PDI says the renewal of contract sales agreement between its SAT unit and a “major” pharmaceutical firm will generate some $6.6m (€5.1m) this year.
MDS has formed a special committee to improve shareholder value following poor results and pressure from investors to sell some of its business units, which include a CRO division.
Logistics specialist GAC says its Shipping and Cargo unit has signed a new contract with Philipino drug distributor Zuellig Pharma.
Haupt Pharma has acquired Pfizer’s production facility in Latina, Italy, which moves the contract manufacturer into antibiotics and allows it to provide additional services to clients.
Parexel’s eClinical subsidiary Perceptive Informatics has entered into an alliance with AG Mednet to improve the efficiency and quality of the electronic image transfer process.
Covance has expanded its presence in central and eastern Europe and Middle East with the opening of offices in Ukraine, Slovakia and Israel.
Benson Medica, part of UK industrial packaging group Benson, is ready to roll-out pharmaceutical labelling at its facility in Crewe.
US company PRA International has entered into a strategic collaboration with two contract research organizations (CROs) in Southeast Asia in order to tap the fast-growing clinical research market in the region.
Almac Pharmaceutical Services has won the contract to produce packaging for physician samples of Middlebrook Pharmaceuticals antibiotic Moxatag (amoxicillin).
Contract research organisation PharmaNet Development Group has found a buyer just a few weeks after saying it was considering placing itself on the block.
Falling API sales and “an unprecedented negative economic environment” have forced Perrigo to cut its fiscal 2009 profit forecast and sent stock plummeting by 20 per cent.
Angel Broking, a leading Indian stock broker, has predicted that the custom research and manufacturing services (CRAMS) sector is best positioned to profit from the difficulties facing pharma.
A team of US scientists have assembled clusters of cells into living ‘microtissues’ as part of a programme aimed initially at reducing the use of animal models in early-stage drug development.
Almac Sciences, part of global contracting group Almac, chose this year’s Informex in San Francisco, US to showcase its solid state chemistry (SSC) services to drugmakers in North America.
A US federal appeal court has reinstated lawsuits by Nigerian families against Pfizer in a move that could have wide ranging implications for companies conducting clinical trials abroad.
US contract developer Xcelience has added small-scale batch production capability to its repertoire of good manufacturing proactice (GMP) accredited production services in a bid to attract drug firms working with small quantities of API.
Canadian contract manufacturing organisation PharmEng International, which has been hit by dwindling cash reserves in recent months, got a boost last week when its subsidiary Keata Pharma was awarded a C$3m research grant.
Outsourcing-Pharma.com presents its periodic round-up of executive appointments in the contract services sector.
US contract development firm Azopharma has begun offering microdosing at its AvivoClin facility in Daytona Beach, Florida, joining market leaders like Xeleron and Covance in the Phase 0 trial sector.
Indian IT company Satyam continues to be rocked by the fraud scandal, with media reports claiming that GSK and Novartis are on the verge of taking their business elsewhere.
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