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All news articles > April 2008
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30-Apr-2008
Sweden recalls Sanofi's enoxaparin after OSCS contamination
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.
Prolient takes major step forward in BSA production
US-based Prolient has improved its "closed loop" bovine serum albumin (BSA) manufacturing process, in what it describes as a "major step forward".
Kyowa Hakko biochemicals prosper on back of acquisitions
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.
Pharmaceutical manufacturing: people on the move
in-PharmaTechnologist.com presents its periodic round-up of personnel changes in pharmaceutical manufacturing and development.
Dr Reddy's buys BASF contract unit
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.
29-Apr-2008
Non-allergenic latex glove gets the nod
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).
Recipharm eyeing dominant CDMO spot
Swedish firm Recipharm is concentrating its efforts on becoming one of the leading contract development and manufacturing organisations (CDMOs).
DSM acquires PTG and predicts record year
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.
siRNA delivery difficulties to meet a sticky end?
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.
US govt pays Sanofi Pasteur $192m for bulk flu antigen
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.
28-Apr-2008
Pharmaceutical facility news in brief
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.
Unigene launches joint venture with Chinese state
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 makes rental an option for water purification
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.
Schott forms joint venture to crack Indian vial market
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.
HP printer to stamp out counterfeiting
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.
24-Apr-2008
EU urges greater pharma, academia links
The European Commission has urged member states to more effectively convert knowledge acquired through research into socio-economic benefits.
Jubilant's overseas operations boost sales
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.
FDA links contaminant to adverse events: issues warning to China facility
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.
OSCS detection may protect heparin supplies
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.
Pharmaceutical manufacturing: people on the move
in-PharmaTechnologist.com presents its periodic round-up of personnel changes in pharmaceutical manufacturing and development.
23-Apr-2008
Biocatalyst specialist Codexis files IPO
US-based biotech company Codexis has filed an initial public offering (IPO), the first step towards becoming a public company.
Genzyme knockback has implications for biosimilars
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.
Rapid flu response planned by Sepragen, Neugenesis
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.
EU updates annex covering computerisation
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.
22-Apr-2008
FDA China presence imminent; DIA sets up in India
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.
Legislation proposed for FDA foreign inspections
Draft legislation has been put forward which would require the US Food and Drug Administration (FDA) to inspect foreign manufacturing plants every four years.
Contract manufacturing news in brief
CMC Icos Biologics, Farmaceutici Formenti SPA, Florida Biologix and JR Scientific have all recently announced new contract manufacturing developments.
Novozymes licenses fast DNA engineering technology
Germany-based Gene Bridges has licensed its Red/ET Recombineering technology to Novozymes for genetically engineering recombinant micro-organisms for use in industrial applications.
Pfizer to continue with manufacturing cuts
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.
21-Apr-2008
FDA appoints Torti to coordinate research
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".
Manufacturing development news in brief
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.
Collette to show "revolutionary" granulation machine
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.
Blackstone sells Gerresheimer stake
US-based private equity group Blackstone has decided to sell its 25 per cent stake in German pharmaceutical packaging specialist Gerresheimer.
Three CMOs unveil new facilities
Three large contract manufacturing organisations (CMOs), Patheon, Metrics and Penn Pharmaceuticals, have all announced new facility openings.
17-Apr-2008
FDA issues pharmacogenomics guide
The US Food and Drug Administration (FDA) has released a document in an attempt to harmonise pharmacogenomic definitions and sample coding guidance.
FDA suspects heparin contamination due to fraud
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.
Canada seeks to shift safety burden back to drug makers
Pharmaceutical firms operating in Canada could face increasing regulatory pressure if government plans to tighten up consumer protection laws are passed.
Pharmaceutical manufacturing: people on the move
Dr Hans Groeger has been appointed to the role of site manager at Roche Carolina's Florence facility.
AIR pullout claims 500 jobs at Lilly
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.
16-Apr-2008
EC promotes REACH pre-registration scheme
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.
Amcor scoops award for child-resistant packaging
Australia-based packaging company Amcor Flexibles has received a Silver Award in Technical Innovation from the Flexible Packaging Association (FPA).
Inhaled migraine drug VR147 shows early promise
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.
Liver cancer slowed by Biocompatibles beads
UK-based Biocompatibles International has presented positive results for the use of its drug-eluting beads for patients awaiting liver transplants.
15-Apr-2008
Alcon to build manufacturing plant in Singapore
US-based ophthalmic specialist Alcon has given a boost to the flagging Singapore pharmaceutical manufacturing industry by building a plant there.
Contract manufacturing news in brief
Laureate Pharma, Progen Pharmaceuticals and Alembic have all recently announced new contract manufacturing news.
Pharmsource provides contract services industry overview
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.
Robot cuts bottleneck in sterile syringe filling
A new robot that can cope with the demands of aggressive sterilization is bringing automation into new areas of the pharmaceutical production suite.
Plastics division driving Gerresheimer in Q1
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.
14-Apr-2008
GSK lets exclusivity period on TPR100 expire
GlaxoSmithKline has opted not to sign an exclusive development agreement with UK sexual health specialist Futura Health for its transdermal pain relief product, TPR100.
Heparin death tally worsens; FDA issues device warning
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.
Indian government assists expansion into Russia
The Indian Ministry of Commerce is planning to set up a warehouse in Russia for Indian pharmaceutical exporters to store their goods in.
MannKind stumbles in fallout from Exubera
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.
Inotek selling off manufacturing plant in cut-backs
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.
10-Apr-2008
Effectiveness of generics called into question
Recent months have seen a number of different organisations call into question the effectiveness of generics in comparison to their brand name counterparts.
Lung cancer warning a death knell for inhaled insulin?
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 buys Chinese API manufacturer
Actavis has purchased a 90 per cent stake in Zhejiang Chiral Medicine Chemicals (CMC), a Hangzhou, China-based active pharmaceutical ingredients (API) maker.
Cortegra acquires digital fingerprinting technology
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 pays Acusphere $10m for HDDS license
Cephalon has licensed the hydrophobic drug delivery system (HDDS) and a reformulated version of paclitaxel, called AI-850, from Acusphere in a $10m deal.
09-Apr-2008
Group takes aim at UK science skills shortage
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.
GE offers new kit to streamline process development
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.
Injectables to drive growth in US drug delivery market to 2012
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.
Pharmaceutical manufacturing: people on the move
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.
Delcath liver isolation device shows promise in cancer trial
US-based Delcath Systems has achieved positive results in treating diffuse liver cancer using its percutaneous hepatic perfusion (PHP) delivery system.
08-Apr-2008
Compliance packaging emerging to tackle patient adherence
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 $86m IPO to fund needle-free development
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.
Pharma cost pressures promise steady growth for excipients market
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.
Lonza breaks the mould with microbiological testing kit
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.
India converts failing vaccine plants to testing labs
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.
07-Apr-2008
US District finds for GSK in patent amendments case
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.
Emerson to automate China's first mAb drug plant
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.
Novartis eyes new markets by taking Alcon stake
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 invests another EUR 130m in Irish facility
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.
Jubilant to buy Draxis in $255m deal
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.
03-Apr-2008
Bosch makes liquid filling a disposable option
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.
US and Chinese pharmacopoeias expand working relationship
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.
Patheon talks CMO strategies for success
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.
M&A movement in India with three top firms
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.
Jobs under threat as Schering-Plough reorganises
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.
02-Apr-2008
CBE labelling rule does not let manufacturers off the hook, FDA insists
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 buoyed by biopharma, Asian markets in 2Q
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.
Novozymes licenses albumin technology to CSL Behring
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.
Microbial testing steps up a gear with Growth Direct
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 Patrol keeps a close eye on PAT
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.
01-Apr-2008
BioKinetics offers help for bioprocess skills shortage
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 extends TFF filter range with microscale unit
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.
Isogen moves to fill small-scale injectables gap
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 unveils new biopharma tools
Gore PharmBio chose this year's Interphex trade show to showcase two new products to assist biomanufacturers.
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