Since coming into effect late last year, US Code of Federal Regulations-21 parts 210 and 211 testing rules have been the subject of much confusion in the pharmaceutical industry, according to West Pharmaceutical Services.
SGS Life Science Services opened a new microbiology testing laboratory in Shanghai, China to offer cGMP compliant API testing services for method development and validation.
The three main international pharmacopoeias in the US, Europe and Japan are experiencing a difference of opinion on the tricky topic of testing pharmaceutical ingredients for heavy metals.
WIL Research Laboratories has expanded into protein and small molecule bioanalysis and genetic toxicology through the acquisition of Midwest BioResearch.
Contract research firm Covance has been given the green light for its $100m (€77m) animal testing and drug candidate development facility in Chandler, Arizona, US.
Clinical laboratory services company LabCorp saw its shares slide yesterday after cutting back its sales and earnings targets for 2009 in light of the economic downturn.
Contract research organization Pharmaceutical Product Development Inc (PPD) has moved further into providing central laboratory services with the purchase of a 130,000 sq. ft. laboratory from Merck & Co.
Simple preclinical experiments should be able to predict whether immunotherapeutic medicines are safe to advance to preclinical testing in humans and avoid the Northwick Park trial that left six healthy volunteers hospitalised.
CiVentiChem president Bhaskar Venepalli says that the CiVentiAnalytical unit, the firm’s new state of the art GLP/cGMP accredited laboratory in Cary, North Carolina, will help customers find novel method development solutions for API production.
Clinical research specialist PharmaNet Development Group reported a decline in both sales and earnings for the third quarter but has kept its guidance for the financial year at the same level, albeit excluding an as-yet unresolved impairment charge.
The pharmaceutical industry must adapt its processes and strategies to cope with a new, tougher operating environment, according to Stefan Borgas, CEO of Lonza.
Johnson & Johnson has tapped Chinese WuXi PharmaTech for additional R&D services, following the trend towards high-level, strategic collaborations between drugmakers and contract research organisations.
With big pharma and biopharma looking to cut costs and increase efficiency, liquid handling experts Artel have found that their services are in greater need than ever before.
After months of deliberations, a court in Iowa has opted to fine contract manufacturing company Cambrex $6,000 for safety violations after an explosion at its facility in Charles City.
San Diego-based biotechnology contract research organisation (CRO) Bio-Quant has expanded its animal diagnostic services offering to cover all nine species used in medical research.
Almac Sciences of Northern Ireland has introduced a new business unit covering solid state chemistry in a move that addresses a missing link in its technology portfolio.
Pfizer is shifting its research focus to those diseases where its sees the potential for the biggest treatment improvements and profits, while dropping eight disease areas including cholesterol.
French firm Novasep has significantly boosted its ability to provide customers with enantiomerically pure compounds with the addition of a new chiral chromatography unit.
UK-based automation expert, Astech Projects, has been signed up to assist a ‘top 5 pharmaceutical company’ just months after launching its new automation maintenance service.
Indian pharmaceutical companies are making their first forays in the biotechnology arena, helping the market expand from a standing start at the beginning of the decade to reach a value of $2bn in 2006-7, according to a recent report from KPMG.
Ion channel expert ChanTest is expanding its range of ion channel services and cell lines that help identify promising target compounds and those that could cause harmful side effects.
Phylogeny has launched the first microRNA (miRNA) in situ hybridisation detection service to help scientists delve deeper into the mechanisms controlling key biological processes.
Germany-based Diapharm has launched a service allowing pharmaceutical manufacturers to perform joint third-party audits of active pharmaceutical ingredients (APIs).
UK-based Pharmaceutical Profiles has used an imaging technique known as scintigraphy to quantify the effects of Amylin / Eli Lilly’s latest diabetes drug on the stomach.
Pharmatek Laboratories has opened its highly-potent and cytotoxic facility located in San Diego, US, just over a year after announcing its move into this growth area of contract manufacturing.
Charles River Laboratories has agreed to buy US-based drug discovery imaging expert Molecular Imaging Research, Inc. (MIR) for approximately $12.5m (€8.8m) in cash.
Outsourcing-Pharma.com presents its latest round-up of new appointments, employment moves and personnel news in the pharmaceutical contract services sector.
Assay Depot, a new online marketplace which allows bench researchers around the world to choose and buy a broad range of drug discovery services, went live yesterday.
India’s contract manufacturing market is expected to rocket forward over the next couple of years to reach a value of $2.46bn in 2010, according to a just-released report from KPMG.
Canada’s Patheon put in another quarter of robust revenues growth in its third quarter, which coupled with cost-reduction measures helped the firm trim its net loss to $14.7m, down 75 per cent on a year ago.
Australia’s CSL Ltd has signed a $3.1bn agreement to acquire Talecris Biotherapeutics of the US and throw down the gauntlet to rival Baxter International in the plasma-based pharmaceutical sector.
Charles River Laboratories saw its operating income advance 16 per cent to $77m in the second quarter on strong demand for its research services division, and also announced a $53m deal to buy a German contract service organisation.
Eli Lilly took a giant leap down the outsourcing road yesterday with the sale of a major R&D facility to contract research organisation Covance and the forging of additional agreement with Quintiles and i3.
PharmaNet has reported a stellar set of second-quarter results, reversing its year-earlier loss with a $2.2m profit that was driven by a good performance by the firm’s early-stage development business.
Laboratory services and diagnostics company Medtox Scientific has posted a healthy hike in operating profits for the second quarter, despite a challenging operating environment that pegged back sales growth.
Lonza of Switzerland is reaping the benefit of a shift away from bulk chemicals and towards custom manufacturing of high-value pharmaceuticals with a 13 per cent hike in sales in the first half of the year.
Outsourcing-Pharma.com presents its periodic round-up of personnel changes in the pharmaceutical outsourcing arena, with senior appointments at Bristol-Myers Squibb, Parexel and GVK Bio, amongst others.
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