The Challenge of Change - Managing Excipients Control
Colorcon
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Thermo Fisher has launched a new spectrometer that incorporates FT-IR technology for improved clarity and detail, aimed at pharmaceutical process scientists and other chemical disciplines.
China's drug regulatory authority is finally responding to curb its damaged reputation by urging its local authorities to take a more proactive role in stemming what is fast becoming a global heparin contamination, sparked by material sourced in the country.
A planned $60-$70m (€38-€44m) initial public offering (IPO) by US-based drug delivery specialist MonoSol Rx has fallen foul of the credit crunch and fears about a slowing US economy.
IntelliPharmaCeutics is ready to move into full-scale clinical trials with a once-daily oral formulation of oxycodone based on the company's ReXista abuse- and alcohol-resistant technology.
Pharmaceutical manufacturers, distributors and retailers alike have welcomed a unanimous vote by the California State Board of Pharmacy to delay for another two years the implementation of electronic pedigree requirements for tracking drugs from the manufacturer through to the pharmacy.
Canada's SemBioSys Genetics has begun final pre-clinical studies of its novel plant-produced insulin product in preparation for its submission to US regulatory authorities.
New research has shown that the FDA's strict 10-month deadline for a drug's approval following submission may compromise drug safety and lead to insufficient data for precise drug administration.
A new, freely available database has been launched that provides comprehensive information about the 600 known bacteria living in the human mouth. Many of these bacteria also cause infections in the lungs, blood and skin, so the Human Oral Microbiome Database will be an important reference both for researchers working in the field of oral microbiology and researchers investigating the sources of infections throughout the human body.
Biotage has used the American Chemical Society (ACS) Spring 2008 meeting to introduce its new batch microwave synthesiser that allows the full automation of batch sequencing resulting in time savings for users.
The pharmaceutical industry in the UK faces tougher legislation on the disclosure of adverse events in clinical trials following the MHRA's thwarted attempt to prosecute GlaxoSmithKline for allegedly withholding information about risks of suicidal behaviour in children and adolescents taking its antidepressant Seroxat (paroxetine).
The ageing population of the European Union (EU) could result in a stagnation in technological innovation, according to a new report. As science and technology professionals get older and less socially mobile, there are fears that it could result in a loss in scientific expertise.
Research and development investment by America's pharmaceutical and biotechnology research companies reached a record $58.8bn last year, a rise of $3bn since 2006.
Drug regulator Health Canada has published its draft guidelines for pharmaceutical firms seeking to gain approval for biosimilars or "subsequent entry biologics."
They showed promise in everything from drug delivery to the development of superconductive compounds, but so far fullerenes have been difficult to produce and purify in sufficiently large quantities for useful applications.
German based Genomics specialists Febit aim to fully automate genomics research with the introduction of its analyser at Analytica 2008, which enables fully automated processing of microarrays on Geniom biochips.
Medidur has been deemed safe by the Data Safety Monitoring Board (DSMB) for continuation of Phase III clinical trials with no amendments to the protocol.
A new bioinformatics technique, developed by researchers at the US Argonne National Laboratory, is allowing researchers to rapidly screen the genetic sequences present microbial communities.
French group Rhodia has put its gradual retreat from a flagging fine chemicals business on a more formal footing by announcing the break-up of Rhodia Organics.
The generic pharmaceutical industry has given short shrift to the latest congressional attempt to construct a viable approval pathway for biosimilars in the US.
Redpoint Bio has been issued with a patent for an assay technology which tests whether a compound enhances or inhibits the bitter or sweet taste of different ingredients, allowing the company to screen for flavour enchancing compounds.
Outsourcing-Pharma.com compiles the news that has featured in the clinical contract community of late, involving PRA International and Premier Research.
The pharmaceutical industry has lost confidence in the UK as a place to do business to an "alarming degree" and the situation is only set to deteriorate, reveals new research.
Varian, Invitrogen, BMG Labtech and Hosokawa Micron have all recently announced new product launches, detailing a selection of tools and equipment to aid the scientist working in the laboratory environment.
The International Society for Pharmaceutical Engineering (ISPE) is offering a "unique training experience" for pharmaceutical professionals through a partnership with North Carolina State University in the US.
Cambrex Corp, the US-based manufacturer of small-molecule active pharmaceutical ingredients (APIs) and advanced intermediates for the drug industry, has announced that one of its customers is recalling a product for which Cambrex currently supplies the API.
The heparin recall has widened after a lot of heparin sodium USP active pharmaceutical ingredient (API) produced by Scientific Protein Laboratories (SPL) was found to contain a heparin-like contaminant.
MassWorks sCLIPS (self Calibrated Line-Shape Isotope Profile Search), a new software tool for the mass spectrometrist to allow molecular formula determination from accurate mass determinations, was launched at Pittcon by Cerno Biosciences.
Engineers from the U.S think they have discovered a new technique that allows them to control the motion of fluid particles as they pass through the tiny channels that characterise nano-scale technologies such as drug delivery devices.
Japan's Fujifilm Holdings has taken a definitive sidestep into pharmaceuticals after completing a tender offer that gives the camera, photography and information solutions specialist a share stake representing 67.42 per cent of the voting rights of Toyama Chemical.
Genomic services firm Expression Analysis has purchased the first-ever commercially-available technology to allow the sequencing of a single molecule of DNA, without amplification.
The US Food and Drug Administration (FDA) has now identified the contaminant found in samples of Baxter's recalled heparin and confirmed that it is indeed linked to a Chinese manufacturing plant.
The worldwide laboratory chemical reagents market is expected to reach $13.7bn by 2010, buoyed by the biotechnology sector, neuroscience research and proteomics.
Switzerland's Siegfried Holding says that a significant jump in 2007 net profit, up 54 per cent to CHF 49.7m ($50m), vindicates its decision to refocus on the active pharmaceutical ingredients and generics sector.
US-based drug delivery specialist Alkermes is cutting its losses following Eli Lilly's decision to scrap the companies' joint development programme for inhaled insulin.
Scientists have successfully created the first artificial transposon - a piece of DNA which randomly "jump" around the genome, cutting and pasting itself throughout the strands of DNA.
Mid-sized European pharma company Nycomed has struck a deal to offshore the vast majority of its raw materials sourcing to India, in a move which could affect around 200 jobs.
Animal studies reveal that we may be on the road to creating the first inhaled vaccine for tuberculosis, with results showing the vaccine to be at least as effective as the injected form.
Batch pedigrees, obligatory product seals, mass serialisation, mandatory audits and tighter requirements for the manufacture, import, export and transportation of medicinal products are among the legislative steps being considered by the European Commission to counter the growing threat of counterfeit drugs in the EU.
A team of nanotechnologists and chemists based in the USA has created a novel nanovalve that could be used to deliver medications according to the pH environment in the body.
A new modular approach to automating laboratory techniques could ease the process of scaling small-scale manual methods to high-volume commercial production.
A revised glycerin monograph has been announced at the US Pharmacopeial (USP) Convention which it is hoped will further decrease the likelihood of health hazards associated with diethylene glycol-contaminated glycerin.
US scientists believe they may have developed an unusual material that has similar physical properties of gelatine, remaining intact even when deformed over 1,000 per cent. Its make up gives hope to the 355 million arthritis sufferers worldwide.
They play an important role in diseases such as diabetes and epilepsy but until now the structure and activity of proteins found in cell membranes have been little understood compared to proteins dissolved within the cell's cytoplasm, nucleus, and mitochondria.
LabTechnologist.com presents a round-up of new products that have been introduced to the laboratory equipment market of late, including items from Applied Biosystems, Olympus, Gentronix and Radleys.
Applied Biosystems has sequenced a human genome for just $60,000 in a project that significantly undercuts the $100,000 milestone achieved by the industry and setting the scene for a price war between DNA sequencing tool specialists.
A disposable autoinjector that incorporates pre-filled syringes to allow injections to be safely undertaken by patients or non-clinicians has received FDA approval allowing its creators access to the lucrative US market.
The US Food and Drug Administration (FDA) has alerted the media that it has taken a significant step forward in its plans to establish a presence on the ground in China.
A new, more patient-friendly presentation of the growth hormone treatment Omnitrope (rDNA somatropin) has been launched in the US by Sandoz, the generics division of Swiss-based Novartis.
Peptide Technologies showcased their latest rapid automated peptide synthesis equipment at Pittcon 2008, including a new product, the benchtop Tribute instrument.
Dutch biotech Crucell and its US partner DSM Biologics have achieved a record yield of 15 grams per litre with their PER.C6 cell line technology for the production of monoclonal antibodies and recombinant proteins.
The University if Groningen in the Netherlands has established a new research centre dedicated to the growing discipline of synthetic biology and its application to the production of biologic medicines.
A successful and strategically important year,' is how Sartorius CEO Joachim Kreuzburg described 2007, a year highlighted by merger of its biotechnology division with Stedim to boost its presence in the burgeoning biopharmaceutical market.
The costs of introducing any formal good manufacturing practice (GMP) requirements for potentially high-risk pharmaceutical excipients in the European Union would far exceed the likely benefits, concludes an impact assessment for the European Commission.
Pharmaceutical applications in the US market for barrier plastic packaging should continue to generate strong growth over the next five years, as the wider healthcare packaging market carries on expanding above the rate of gross domestic product (GDP), a new report predicts.
Pharmaceutics International has been branching out of late, with an expansion, an acquisition and a new partnership.
Outsourcing-Pharma explores the driving force behind the pharma industry's escalating wandering eye towards emerging markets.
NanoDrop, now part of Thermo Fisher Scientific, made a big impact at Pittcon 2008 with its range of micro-volume UV-vis and fluorescence spectroscopy instruments.
Thermo Fisher released a comprehensive range of new laboratory spectrometers at Pittcon 2008, with the firm's emphasis on FT-IR very much in evidence.
Aspectrics introduced a new biodiesel analyser at Pittcon 2008 based upon their Encoded Photometric Near Infra Red (EP-NIR) technology, which uses a specially designed 128 channel encoder disc.
Research into the use of RNA interference (RNAi) to "silence" gene activity has taken another step forwards, saysThermo Fisher Scientific which has launched an agent that accelerates the processes in which RNAi is used to shut off specific genes.
Germany's Merck KGaA is still on the lookout for acquisitions or in-licensing deals to fill out its pharmaceutical business following the purchase and integration of Swiss biotech Serono.
Politicians in the US have gone on the offensive while regulators and industry groups have circled their wagons over a five-month investigation by the Associated Press that has rung alarm bells about trace levels of pharmaceuticals in drinking water.
European researchers think they may have found a series of DNA switches that control which genes are switched on and when, giving rise to a new research direction that may shed new light on the molecular basis of cancer and development.
A unique device that allows control gene activity during cell multiplication has been produced by US researchers, who believe this technology will allow them to construct pedigrees, comparing gene activity from one cell to the next.
PEGylation specialist Neose Technologies says that it has now refocused its R&D focus since the demise of its lead drug candidate last year, and will concentrate on two drugs for neutropenia and haemostasis in 2008.
A new method for crystallising proteins and making them easier to experiment on has been devised by scientists, who believe this technique will uncover the innermost structure of more complex proteins.
The made-in-China heparin scare has now spread beyond the US, with Germany and Japan both recalling the drug.
Cobra Biomanufacturing, Crucell, Vetter, Arch Pharmalabs and Lonza have all recently announced new contract manufacturing news.
Patheon's first quarter results have continued to be impacted by its underperforming Puerto Rico operations, although restructuring plans to remedy the situation are in full swing.
Roche has entered into an agreement to provide drug compounds for cardiotoxicity testing using a cell-based platform that could play a major role in the preclinical safety evaluation of drugs and newly developed compounds.
A new biosensor made from mouse white blood cells could provide a quick and easy test for microbes and toxins in food. The sensor can return results in just a few hours, and it can be easily scaled to test up to 96 samples at one time.
A silicon tuning fork that changes pitch in the presence of deadly prions could provide an early detection of diseases such as bovine spongiform encephalopathy (BSE) and its human counterpart Creutzfeldt-Jacob disease (CJD).
The CEO of Californian company Nektar Therapeutics says that 2007 has been key in transforming the company into a fully integrated drug development organisation, despite the setback with Pfizer's inhaled insulin product Exubera.
Drug delivery specialist Eurand could see a marked increase in revenue flow this year, both from co-development products incorporating the company's formulation technologies and a proprietary treatment addressing the estimated $720m worldwide market for exocrine pancreatic insufficiency (EPI).
It had been touted as providing a less controversial alternative to embryonic stem cells, but Italian researchers have thrown into question the validity of research claiming to demonstrate the use of amniotic stem cells to generate neural tissue.
The prospects for a viable market in inhaled insulin therapies were looking markedly thinner this week after Eli Lilly pulled the plug on its joint development programme with drug delivery specialist Alkermes for AIR Insulin.
Portugal's Hovione has become the latest in a spate of pharma industry players to invest further in China.
MedImmune is taking advantage of a new US recommendation on the immunisation of school children to almost triple production of its intranasal influenza vaccine, FluMist, for the coming 'flu season.
The promise of genuine returns on investment, facilitated by plummeting hardware costs, will fuel a dramatic growth surge in the US market for radio frequency identification (RFID) technology in pharmaceutical manufacturing and distribution over the next five years, a new report predicts.
Alfa Laval has introduced new plate technology for the continuous production of pharmaceuticals, fine chemicals and speciality chemicals that has "the potential to start something of a revolution in the chemicals industry", the Swedish company claims.
A US Food and Drug Administration (FDA) investigation into the recent Baxter heparin scare has uncovered a contaminant in the product that was sourcing the active pharmaceutical ingredient (API) from a Chinese manufacturer.
LabTechnologist.com brings you a round up of the latest product news and releases. This week Agilent, Biotage and Ruskinn Technology head the queue with products designed for laboratory research and automation.
A joint development partnership between Malvern Instruments and imaging specialist FEI has produced what the companies claim is the first ever tool for determining the size and shape of sub-micron particles through direct analysis.
Fourier transform infrared spectroscopy (FTIR) has hit the headlines at Pittcon 2008 with the release of ground breaking instruments from a number of companies.
A new user and environmentally-friendly fume hood claimed to cut emissions as well as operating and energy costs has been launched at Pittcon 2008.
A "matryoshka doll" filled with drugs could be the missing link that finally allows nanomedicine to fulfil its potential.
Flamel Technologies has yet again experienced a net loss of $37.2m for 2007, following a string of bad fortune in 2005 and 2006, but believes it may be about to turn the corner.
Pfizer has outlined a number of strategies for growing its fledgling pipeline and lowering its cost base and is planning to increase globalisation and accelerate growth in emerging markets as part of this.
Dissolved charged particles frequently form the waste product of both industrial and biological processes, but while it has been easy to remove positive ions (cations) without disturbing the surrounding solution, it has been significantly harder to recover negative ions (anions).
Scientists have provoked a soil-dwelling bacteria into producing a potent antibiotic by pitting it against another bacteria, despite the fact that previously it had never been known to produce such products.
There were distinct signs of faltering progress in the pharmaceutical business of US-based performance materials supplier Ferro Corporation during the fourth quarter and year ended 31 December 2007.
Merck & Co has signed a $32m deal to evaluate MicroDose Technologies' dry powder inhalation technology in the delivery of some of its respiratory product lines.
Applied Biosystems has developed a new chemistry reagent kit for DNA analysis by forensic laboratories of material recovered in sexual assault cases. In these cases speed and accuracy are the watchwords and the new kit will help the analyst to rapidly generate information from any complicated DNA evidence that is presented.
Bio-Rad Laboratories has reported strong growth in the last quarter of 2007, with a 34 per cent increase in revenue compared to the last quarter of 2006. These results have contributed to an overall 14.7 per cent increase in sales for 2007, to $1.46bn.
Applera has announced its intentions to separate its Celera Group from the Applera Corporation, forming a separate, publicly-traded company, subject to approval from the US Securities and Exchange Commission and Applera's board of directors.
The US Food and Drug Administration (FDA) has alerted the media to the preliminary findings of its inspection of the Chinese facility that supplied the active pharmaceutical ingredient (API) for Baxter's heparin - now recalled from the market after a safety scare.
The globalisation of the supply chain increasingly challenges the US Food and Drug Administration's ability to ensure the quality of pharmaceuticals on the US market, acknowledges the acting director of the agency's Center for Drug Evaluation and Research.
Dutch biotech Pharming has solidified its patent position in the use of transgenic cattle to produce protein therapeutics through a licence agreement with Advanced Cell Technology (ACT), a US company developing stem cell therapies for regenerative medicine.
A "biodegradable yarn ball" filled with stimulatory proteins that boost the immune system could constitute the next generation of adaptive immunotherapy for cancer.
German chemicals giant BASF has announced its latest brace of price rises, this time for two forms of carboxylic acid and for bleaching and reducing agents.
Life sciences systems maker Bruker Corp reported stronger-than-expected fourth-quarter earnings and revenue results on the back of the company's recent $1.1bn acquisition of affiliated firm Bruker BioSpin.
With active pharmaceutical ingredient sales of $1,460m (€960.8m) in 2007 and a portfolio of more than 250 compounds, Teva Pharmaceutical Industries is by a long stretch the dominant supplier in the global API market.
A new study shows how to get high quality immune-system protein information at the fraction of the current cost. Researchers have introduced a statistical model, which makes use of existing high quality molecule data to infer information from cheaper low quality data.
Researchers applying to the US National Institutes of Health (NIH) for research grants could find the complicated peer-review process easier to navigate in the future under new proposals designed to revamp the outdated system.
A UK chemicals plant has become the latest casualty of GlaxoSmithKline's (GSK's) pledge to make the business leaner with the help of outsourcing and offshoring.
Pittcon 2008 has kicked off and as usual exhibitors have kept their newest and most innovative technology for release at the show. LabTechnologist.com's Huw Kidwell is on the ground in New Orleans to see what's new.
A long-acting injectable formulation of Eli Lilly's blockbuster schizophrenia treatment Zyprexa (olanzapine), with the potential to improve patient adherence and take some of the sting out of generic competition three years down the line, has fallen at the final hurdle before US approval.
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