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Swedish authorities have recalled Sanofi Aventis' low molecular weight injectable blood thinner Lovenox (enoxaparin), known locally as Klexane, after four batches of the blockbuster drug were found to contain oversulfated chondroitin sulphate.
US-based Prolient has improved its "closed loop" bovine serum albumin (BSA) manufacturing process, in what it describes as a "major step forward".
Japan-based Kyowa Hakko's biochemical segment has experienced 135.6 per cent growth taking the departments operating income for the 2007 financial year to $92.4m.
in-PharmaTechnologist.com presents its periodic round-up of personnel changes in pharmaceutical manufacturing and development.
India's Dr Reddy's Laboratories has just announced the signing of a definitive agreement to buy the US pharmaceutical contract manufacturing business of chemicals giant BASF.
A new type of latex glove developed by Yulex Corp that is less allergenic for medical and research staff has been given a green light by the US Food and Drug Administration (FDA).
Swedish firm Recipharm is concentrating its efforts on becoming one of the leading contract development and manufacturing organisations (CDMOs).
Dutch chemical group DSM has acquired Polymer Technology Group (PTG) and predicted its best financial year to date following organic sales growth of 14 per cent for the first quarter.
French firm Polyplus-transfection hopes that its new "sticky siRNA" (ssiRNA) technology, which allows siRNA molecules to form more stable structures, will revolutionize the in vivo delivery of small interfering-RNA based therapies.
The US Department of Health and Human Services (HHS) has accepted a bulk stock of H5N1 influenza virus antigen, consisting of both hemagglutinin and neuraminidase, worth $192m (€123m) from French vaccines specialist Sanofi Pasteur.
in-PharmaTechnologist.com's periodic round-up of developments in the pharmaceutical manufacturing space includes news of two new production plants, one R&D facility and the closure of a manufacturing site.
US drugmaker Unigene has begun construction of new facilities in China as part of its joint venture with a state-owned Chinese pharmaceutical company to establish research, development and manufacturing capacities in the nation.
ELGA Process Water has launched its new All-in-Pack water treatment solution for pharmaceutical manufacturers wishing to reduce both capital expenditure and associated running costs.
German-based technology group Schott has formed a joint venture with Kaisha in an attempt to gain access to the glass primary pharmaceutical packaging market in India.
Computer giant Hewlett-Packard (HP) has developed a system that allows high quality printing to be added to tablets and capsules in an attempt to derail counterfeiters.
The European Commission has urged member states to more effectively convert knowledge acquired through research into socio-economic benefits.
A 67 per cent increase in the contribution from overseas operations helped boost Indian custom research and manufacturing services (CRAMS) group Jubilant Organosys' sales in fiscal 2008.
The US Food and Drug Administration (FDA) has revealed evidence linking the heparin contaminant with the series of reported adverse reactions, and has also now issued a warning letter to the Chinese facility at the centre of the safety scare after completing its inspection.
International research suggests that a simple in vitro bioassay, in addition to procedures currently in place, would help secure the global supply chain for heparin and reduce the risk of patients being exposed to harmful contaminants.
in-PharmaTechnologist.com presents its periodic round-up of personnel changes in pharmaceutical manufacturing and development.
US-based biotech company Codexis has filed an initial public offering (IPO), the first step towards becoming a public company.
The problems facing companies trying to bring 'biosimilar' versions of biologic drugs to market were thrown into stark relief yesterday when the US Food and Drug Administration (FDA) refused to approve Genzyme's genetic disorder treatment Myozyme made at the firm's Allston facility.
US firms Sepragen and Neugenesis are teaming up to develop a high-throughput platform for monoclonal antibody and influenza vaccine production that is rapid, scalable and flexible enough to respond to a potential pandemic.
The European Commission has updated its annex covering computerisation of process control, documentation and data-processing systems to take into account developments in the field.
The US Food and Drug Administration (FDA) has revealed it will be operating on the ground in China imminently, while the Drug Information Association (DIA) has just planted itself in Asia's other pharma don, India.
Draft legislation has been put forward which would require the US Food and Drug Administration (FDA) to inspect foreign manufacturing plants every four years.
CMC Icos Biologics, Farmaceutici Formenti SPA, Florida Biologix and JR Scientific have all recently announced new contract manufacturing developments.
Germany-based Gene Bridges has licensed its Red/ET Recombineering technology to Novozymes for genetically engineering recombinant micro-organisms for use in industrial applications.
US drug giant Pfizer plans to close or sell off an additional 13 manufacturing facilities as part of an effort to cut its number of production plants to 44 by the end of 2009.
Frank Torti has been appointed to the newly created post of chief scientist at the FDA, with a brief to "oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs".
in-PharmaTechnologist.com's periodic round-up of developments in the pharmaceutical manufacturing space includes news of three new facilities, plus some interesting product launches and updates.
GEA Pharma Systems' Collette unit will present Consigma, its new continuous high shear granulation and drying system, at the Interpack exhibition in Düsseldorf later this month.
US-based private equity group Blackstone has decided to sell its 25 per cent stake in German pharmaceutical packaging specialist Gerresheimer.
Three large contract manufacturing organisations (CMOs), Patheon, Metrics and Penn Pharmaceuticals, have all announced new facility openings.
The US Food and Drug Administration (FDA) has released a document in an attempt to harmonise pharmacogenomic definitions and sample coding guidance.
The US Food and Drug Administration (FDA) believes that the contamination of Baxter's blood thinner heparin, which has been linked to 62 deaths in the US, may have been due to the deliberate replacement of some ingredients with cheaper alternatives.
Pharmaceutical firms operating in Canada could face increasing regulatory pressure if government plans to tighten up consumer protection laws are passed.
Dr Hans Groeger has been appointed to the role of site manager at Roche Carolina's Florence facility.
Eli Lilly plans to cut 500 jobs, mainly in manufacturing, as it attempts to restructure its operations to mitigate against the losses from inhaled insulin.
The European Commission (EC) has launched a promotional campaign urging European chemicals companies to pre-register for the new REACH chemicals regulations to avoid potential disruption to operations.
Australia-based packaging company Amcor Flexibles has received a Silver Award in Technical Innovation from the Flexible Packaging Association (FPA).
New data from an early-stage trial of Vectura's inhaled migraine candidate VR147 suggest that it could offer significant advantages over currently-available treatments.
UK-based Biocompatibles International has presented positive results for the use of its drug-eluting beads for patients awaiting liver transplants.
US-based ophthalmic specialist Alcon has given a boost to the flagging Singapore pharmaceutical manufacturing industry by building a plant there.
Laureate Pharma, Progen Pharmaceuticals and Alembic have all recently announced new contract manufacturing news.
Overall, 2007 was another stellar year for contract service providers, particularly those at the early-stage end of development, although companies are advised to watch out for a tougher environment ahead.
A new robot that can cope with the demands of aggressive sterilization is bringing automation into new areas of the pharmaceutical production suite.
German packaging giant Gerresheimer reported a positive set of first quarter results for 2008, largely due to the success of its plastics division in the expanding medical plastics market.
GlaxoSmithKline has opted not to sign an exclusive development agreement with UK sexual health specialist Futura Health for its transdermal pain relief product, TPR100.
The number of people whose deaths are associated with an allergic reaction to heparin has shot up as the US Food and Drug Administration (FDA) has updated its tally.
The Indian Ministry of Commerce is planning to set up a warehouse in Russia for Indian pharmaceutical exporters to store their goods in.
MannKind has suspended its search for a potential partner for its inhaled insulin product Technosphere in the wake of the news of Exubera's possible cancer risk.
US firm Inotek has launched a restructuring programme which will see its Israeli manufacturing plant sold off and all operations brought back to its Massachusetts headquarters.
Recent months have seen a number of different organisations call into question the effectiveness of generics in comparison to their brand name counterparts.
Pfizer has updated the US product labeling of its inhaled insulin treatment Exubera to include a warning of increased risk of lung cancer among those using it.
Actavis has purchased a 90 per cent stake in Zhejiang Chiral Medicine Chemicals (CMC), a Hangzhou, China-based active pharmaceutical ingredients (API) maker.
US printing and services firm Cortegra has forged an exclusive partnership with French firm Signoptic to provide the US market with a new technology designed to detect counterfeit drugs in the supply chain.
Cephalon has licensed the hydrophobic drug delivery system (HDDS) and a reformulated version of paclitaxel, called AI-850, from Acusphere in a $10m deal.
A new set of draft guidelines aims to identify the core scientific competencies required by firms working in the UK's £3.3bn (€4.2bn) bioscience sector.
Two products aimed at enhancing the efficiency of process development in biopharmaceutical manufacturing are the latest offerings from GE Healthcare, the UK-based medical technology and services company.
US demand for drug delivery systems is set to increase by over 10 per cent a year, reaching $132bn in 2012 with growth driven by injectable biologic dugs, according to a new study by the Freedonia Group.
Stiefel Laboratories, Biopharm Services, Multisorb Technologies, the Pharmaceutical Research and Manufacturers of America, Catalent Pharma Solutions and Chromatide have all had people on the move in the world of pharmaceutical manufacturing.
US-based Delcath Systems has achieved positive results in treating diffuse liver cancer using its percutaneous hepatic perfusion (PHP) delivery system.
Compliance packaging is emerging as a way to help tackle the challenge of patient adherence to medication, which costs pharmaceutical manufacturers over $30bn a year in lost revenues.
Zogenix says that proceeds from a planned $86m initial public offering (IPO) will be used to fund development of its pipeline of needle-free medicines for pain and central nervous system indications.
The unremitting pressure to cut costs, ward off generic competition and compensate for lack of innovation in the pharmaceutical market should ensure steady annual growth for drug excipients over the next five years, a new report predicts.
A rapid microbial detection kit presented as the only genetic-based test on the market to quantify yeast and mould has been launched by Switzerland's Lonza.
The Indian government has reacted to the enforced closure of three of its oldest vaccine manufacturing plants by launching a plan to convert them to drug testing laboratories.
GlaxoSmithKline (GSK) has scored a decisive victory in its efforts to head off new US patent rules that would strike at the heart of the way the drug industry goes about protecting its inventions.
US-based engineering services firm Emerson announced at Interphex that it has been selected to digitally automate a new facility in China that will produce the country's first monoclonal antibody (mAb) drugs.
Swiss-based Novartis has acquired a 25 per cent stake in Alcon, a US-based company specializing in ophthalmics, which ranks among the fastest-growing therapeutic sectors in pharmaceuticals.
Genzyme is putting another €130m into its manufacturing facility in Waterford, Ireland, where the US biotech first put down roots in 2001 and has been steadily expanding ever since.
India's Jubilant Organosys has made good on promises to make acquisitions in the contract research and manufacturing services (CRAMS) sector with a $255m deal to buy Draxis Health of Canada.
The use of disposable manufacturing equipment in pharmaceutical production and greater need for containment equipment were recurring themes at the Interphex show in Philadelphia last week, and both were addressed by new equipment from Bosch Packaging Technology.
The pharmacopoeias of the US and China will work more closely together in future in a bid to improve the quality of medicines available in both countries.
Steven Liberty, senior vice president of operations for Patheon's North American businesses spoke at Interphex on the strategies contract manufacturing organisations (CMOs) can use to obtain a competitive advantage.
Three of India´s large pharmaceutical manufacturers, Dr Reddy's, Ranbaxy Laboratories and Shilpa Medicare have just announced new merger and acquisition (M&A) deals.
US drugmaker Schering-Plough is to reduce the numbers of its manufacturing plants and cut its R&D expenditure in an attempt to achieve savings of $1.5bn by 2012.
The US Food and Drug Administration (FDA) has defended its proposed rule on product labelling changes made unilaterally through "changes being effected" (CBE) supplements against accusations from Congress, trial lawyers and other quarters that it would shield manufacturers from tort liability under state law.
Pall seems to have shaken off the financial turmoil of recent months in the second quarter of 2008, with a 15 per cent hike in sales to $626m helped by favourable dollar exchange rates and a strong performance by its biopharmaceuticals division.
Denmark's Novozymes has signed an exclusive worldwide licensing agreement with CSL Behring for albufuse, a proprietary albumin fusion technology that can extend the circulatory half-life of therapeutic proteins through genetic fusion to recombinant human albumin.
With manufacturing productivity in the pharmaceutical sector widely acknowledged as being in need of modernisation, a US firm believes it has developed a technology that could carve days off the time spent on microbial testing, a cumbersome but ubiquitous part of the quality control process.
Waters Corp unveiled a new concept in Process Analytical Technology (PAT) at Pittcon 2008 when it released the new Patrol UPLC (ultra performance liquid chromatography) process analyser, which can be incorporated directly into a process.
Bioprocessing consultancy specialist BioKinetics has unveiled a series of online training modules designed to address skill shortages that it says are a major issue facing biopharmaceutical manufacturing operations.
Millipore used Interphex in Philadelphia as a platform to launch a new product in its Tangential Flow Filtration (TFF) range aimed at removing impurities from biologic products.
Sterile process engineering consultancy firm Isogen is taking a maiden voyage into the manufacturing side of drugs with the construction of its first facility, aimed to fill a gap in small-scale injectables.
Gore PharmBio chose this year's Interphex trade show to showcase two new products to assist biomanufacturers.
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