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All news articles > March 2008
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30-Mar-2008
Credit crunch sinks MonoSol IPO
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.
California gives industry a two-year reprieve on ePedigree
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.
China watchdog responds to heparin scare; AZ now affected
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.
Thermo unveils FT-IR spectrometer
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.
Abuse-resistant oxycodone primed for clinical trials
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.
27-Mar-2008
SemBioSys prepares to file novel insulin product with FDA
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.
No joy for MHRA but tighter rules for pharma following Seroxat probe
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).
Record R&D investment in US
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.
EU's ageing science workforce could damage future innovations
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.
FDA deadlines compromise drug safety
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.
26-Mar-2008
Redpoint Bio receives taste sensor patent
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.
Health Canada issues draft rules for subsequent entry biologics
Drug regulator Health Canada has published its draft guidelines for pharmaceutical firms seeking to gain approval for biosimilars or "subsequent entry biologics."
UK pharma industry set to lose business offshore
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.
New US biosimilars bill a disappointing distraction, says GPhA
The generic pharmaceutical industry has given short shrift to the latest congressional attempt to construct a viable approval pathway for biosimilars in the US.
DSMB backs Medidur
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.
Clinical contract news in brief
Outsourcing-Pharma.com compiles the news that has featured in the clinical contract community of late, involving PRA International and Premier Research.
Researchers achieve scalable fullerene production and separation
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.
Rhodia starts to unravel Organics business
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.
25-Mar-2008
Customer recalls product using Cambrex API
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.
ISPE links with university for hands-on biopharma training
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.
Heparin recall widens in US
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.
Toyama acquisition shows Fujifilm's pharma ambitions
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.
Expression Analysis buys novel DNA sequencing technology
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.
20-Mar-2008
FDA identifies heparin contaminant; confirms China link
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.
Alkermes takes AIR Insulin blow with redundancies, facility closure
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.
Inhaled TB vaccine shows promising results
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.
Generic drag cant hold back Siegfried's API momentum
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.
Nycomed takes bulk of API production offshore
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.
19-Mar-2008
US team claims a first in nanovalves for drug delivery
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.
Commission sets out its stall on anti-counterfeiting measures
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.
Hydrogel success calls for jolly good knees-up
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.
Revised glycerin monograph announced to combat contamination
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.
18-Mar-2008
Omnitrope Pen 5 ups the convenience factor
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.
Crucell, DSM hit 15g/L milestone with PER.C6 technology
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.
TMH autoinjector to reach US after FDA go-ahead
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.
FDA makes progress in plans for China presence
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.
Synthetic biology research centre established in NL
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.
17-Mar-2008
Pharma: why the wandering eye towards emerging markets?
Outsourcing-Pharma explores the driving force behind the pharma industry's escalating wandering eye towards emerging markets.
Sartorius mergers cap off 'a successful and intense 2007'
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.
Strong growth seen in US for barrier plastic packaging
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 branching out
Pharmaceutics International has been branching out of late, with an expansion, an acquisition and a new partnership.
GMP an unnecessary burden for excipients, review concludes
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.
12-Mar-2008
Merck KGaA still has an eye to buy in pharma
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.
Neose to advance PEG products in 2008
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.
Pharmaceutical traces in water 'highly unlikely to harm', says industry
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.
11-Mar-2008
Patheon's Q1 profits drop as it continues to address Puerto Rico
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.
Contract manufacturing news in brief
Cobra Biomanufacturing, Crucell, Vetter, Arch Pharmalabs and Lonza have all recently announced new contract manufacturing news.
Nektar optimistic despite Exubera fallout
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.
Lilly declines to inhale with AIR Insulin programme
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.
China-made heparin scare spreads beyond US
The made-in-China heparin scare has now spread beyond the US, with Germany and Japan both recalling the drug.
Eurand's formulations stack up at the FDA
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).
10-Mar-2008
US pharma RFID market set for 60 per cent growth
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.
Continuous reactor promises production 'revolution'
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.
Hovione makes latest investment in China
Portugal's Hovione has become the latest in a spate of pharma industry players to invest further in China.
ACIP recommendations are a seasonal bounty for FluMist
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.
07-Mar-2008
Heparin contamination emerges after FDA China investigation
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.
06-Mar-2008
Fumehood maker shows rivals how to go green
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.
Pfizer eyeing emerging markets in growth plan
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.
Flamel suffers greater losses in 2007
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.
Direct particle analysis at the nano level
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.
'Nested' nanoparticles increase efficiency of drug delivery
A "matryoshka doll" filled with drugs could be the missing link that finally allows nanomedicine to fulfil its potential.
05-Mar-2008
Donut-shaped organic molecule mops up chemical waste
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).
Ferro's pharma business falters in Q4, 2007
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.
Fighting bacteria produce new antibiotic
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.
MicroDose and Merck agree $32m DPI deal
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.
04-Mar-2008
FDA 'concerned' after inspection of China heparin plant
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.
Supply chain globalisation weighs heavily on FDA
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.
DiaMed helps Bio-Rad to strong growth in 07
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.
Biodegradable 'cells' boost immune system
A "biodegradable yarn ball" filled with stimulatory proteins that boost the immune system could constitute the next generation of adaptive immunotherapy for cancer.
ACT licence beefs up Pharmings transgenic cattle portfolio
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.
03-Mar-2008
Teva sprints ahead of the API field
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.
Lillys Zyprexa LAI trips up over sedation effects
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.
GSK's UK plant to lose out to outsourcing
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.
NIH to lighten up heavy peer review process
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.
BASF hikes prices on intermediates, hydrosulfites
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.
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