The Challenge of Change - Managing Excipients Control
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There are lessons to be learned about the importance of rigorous due diligence of pharma contractors, now that Inyx' customers are facing possible supply issues and a scramble to find alternative manufacturers after the firm's collapse.
A once-weekly Type II diabetes treatment has shown promise when compared to its twice-daily counterpart.
Covance is feeling positive after reporting healthy growth in both business units for the third quarter, with its early phase segment continuing to have the edge over its late stage unit.
A nifty spray-on solution could make all the difference for men plagued with the problem of climaxing too soon, as the product makes its final thrust in clinical development.
Pfizer, Savient Pharmaceuticals, Teva Pharmaceuticals, NPS Pharmaceuticals and MicroCHIPS have all had people on the move in the world of pharmaceutical manufacturing.
Nycomed is to acquire Bradley Pharmaceuticals for $346m (€240m) in a bid to make a niche for itself in the dermatology market.
Applied Biosystems (ABI) saw 5 per cent revenue growth during its first quarter of fiscal 2008 as sister company Celera posted revenue growth of 57 per cent.
Thermo Fisher Scientific saw revenues for the third quarter of 2007 rise to $2.4bn (€1.7bn) with its Analytical Technologies division growing 12 per cent with quarterly sales of $1.04bn.
LabTechnologist.com brings you its periodic round up of industry news, with developments at Barloworld Scientific, Beckman Coulter, Harvard Biosciences, Inverness, Nonlinear Dynamics, Oxford Biomedica and ThalesNano.
Thermo Fisher Scientific continues to fish for new opportunities in India and has begun setting up a new clinical services base in the country.
In another safety concern over a long-approved drug, Roche has been forced to add new warnings to its anti-transplant rejection drug CellCept (mycophenolate mofetil (MMF)) amid the news that it is associated with increased risk of miscarriage and congenital birth defects.
Sanofi-Aventis has had to take Inyx USA to court after it failed to deliver on a contract manufacturing and supply agreement, a situation that Aventis feared could "seriously harm its interests". There may be important lessons to be learned for all of big pharma.
Bayer Schering Pharma this week announced that it has scrapped plans to introduce a double-dose version of its top-selling multiple sclerosis (MS) drug Betaferon (interferon beta-1b) by the end of the year following disappointing trial results from its BEYOND study.
Two pharmaceutical companies have faced explosions at their plants in the last week, local media reported.
Action should be taken to curb the counterfeit drug trade, but not via legal intervention, the results of a European survey say.
Summit (formerly VASTox) has signed a $450,000 (€312,000) deal with one of the world's top five pharma firms to enable it to use Summit's zebrafish-platform in its drug safety programme.
Pfizer is already cutting jobs in relation to its failed Exubera with the announcement that some 200 jobs are to go at the drug giant's Portage and Kalamazoo sites, according to local media reports.
Novavax, Cobra Biomanufacturing, Catalent Pharma Solutions, and Suven Life Sciences have all recently announced new contract manufacturing news.
Swiss pharma Novartis today announced the largest manufacturing investment in its history, revealing plans for a $700m (€486.5m) biotech facility to be built alongside its new solid dose plant in the low cost, high quality biopharma hub of Singapore.
Europe's Committee for Medicinal Products for Human Use (CHMP) today released the report from its October meeting, with highlights including GlaxoSmithKline's Avandia (rosiglitazone), Atripla (efavirenz, emtricitabine, tenofovir disoproxil), clobutinol cough products and biosimilar approvals.
Investigations into the use of contact lenses as a drug delivery system have been recommended in a review article.
Figures released today reveal a slow-down in Singapore's pharmaceutical manufacturing output compared to this time last year.
In-PharmaTechnologist.com brings you a selection of other headlines from the pharmaceutical manufacturing industry.
GlaxoSmithKline (GSK) has been swift in implementing its plant cuts, already announcing the first sites to be axed mere hours after revealing its restructuring plans.
The race is on between cervical cancer vaccines Gardasil and Cervarix as they begin to battle it out to win a more than £100m a year supply contract with the UK Department of Health.
GlaxoSmithKline (GSK) is planning to strip itself down closer to the bare bones of the business through further outsourcing and offshoring, with hopes of making itself into a lean, mean, pharma machine.
Illumina's third quarter revenues soared 82 per cent while Affymetrix looked to bolster its slice of the genetics market by filing more patent infringement claims against the young pretender.
LabTechnologist.com brings you a round up of recent product news from Arrayjet, Aspectrics, BioTool, Cerno, IDBS, Olympus, Servocell, Tecan, Thermo Fisher Scientific, Viscotek and Warner Instruments.
MannKind Corporation needs an outside boost to get its inhaled insulin off the ground, but the likelihood of that partner being Pfizer is a 'very long shot', the president of the company says.
Scanning probe microscope (SPM) maker, JPK Instruments has been named as Germany's fastest growing nanotechnology company in accounting firm Deloitte's 'Technology Fast 50'.
Indian generics specialist Wockhardt is continuing its drive to strengthen its foothold in the US market, snapping up US firm Morton Grove Pharmaceuticals.
Contract manufacturer Almac has set its sights on establishing a new US headquarters and has set aside $100m (€70m) for the purpose.
In-PharmaTechnologist.com brings you an update of pharmaceutical patent litigations.
Broad-based sales growth has helped push Waters third quarter revenues up 17 per cent to $353m (€248m) compared with the same period last year.
Sigma-Aldrich continued its strong year with both revenues and pre-tax profits showing strong double-digit growth in the third quarter predicting it will break the $2bn (€1.4bn) revenue mark this year.
GlaxoSmithKline (GSK) has emerged as the latest pharma firm to announce closures and job cuts along with its third quarter results, yet another casualty of generic competition and product safety scares.
Scanning probe microscope (SPM) maker, JPK Instruments has been named as Germany's fastest growing nanotechnology company in accounting firm Deloitte's 'Technology Fast 50'.
Bentley Pharmaceuticals has announced it is planning to split in two in a bid to bolster its two business divisions.
As it faces an increasingly uncertain financial future, Pfizer's reaffirmation that it plans to retain its focus on cutting costs, including outsourcing and offshoring, comes as no 'Kindler surprise', unlike the firm's decision to suddenly walk away from its market failure Exubera.
Novartis, Immunosyn, Alpharma and Cegedim Dendrite have all had people on the move in the world of pharmaceutical manufacturing.
The forecast that 4.5 billion doses of pandemic influenza vaccine could be produced by 2010 is an underestimate, according to GlaxoSmithKline.
A major new trade agreement aiming to combat counterfeiting has been proposed by representatives of a number of key markets, including the US, EU and several other countries worldwide.
Complicated inhaler devices are failing patients according to a recent report, with tricky mechanisms and techniques resulting in low drug delivery and poor disease management.
LabTechnologist.com brings you its periodic round up of industry news, with developments at Bruker, Codon Devices, Invitrogen, Luminex and Thermo Fisher Scientific.
Sigma-Aldrich has continued its push into siRNA delivery with the release of its N-TER nanoparticle system for hard-to-transfect cell lines.
Illumina has released a new microRNA (miRNA) assay for gene expression profiling at a cost that the company believes is less than half that of other commercially available systems.
Pfizer may have given up on its non-injectable insulin, but researchers in the US think they may have cracked a way to deliver the hormone orally, linking it up to vitamin B12 to protect it through the digestive system.
Icon is living up to its name, according to a recent contract research organisation (CRO) survey, which also recognised Quintiles and PPD in terms of quality performance.
Pacira Pharmaceutical's modified-release formulation of morphine has been approved for marketing in Australia by the Therapeutic Goods Administration.
Inyx Pharma has been given a new lease on life after it was bought by another UK firm, bringing relief after it was dragged into administration when its US parent company Inyx Inc. ran aground financially.
Eli Lilly is remaining optimistic about its yet-to-be-approved inhaled insulin despite the dramatic downfall of Pfizer's Exubera. But is Exubera's fall from grace an indication of things to come for inhaled diabetes treatments?
Scanning probe microscope maker Veeco has seen its third quarter revenues drop 13 per cent to $97.7m (€68.7m) and plans to make 100 staff redundant as part of a restructuring drive.
We've all cringed at stories of people dumping their partners via text message but in the world of business, Pfizer seems to have taken things to a new level when its Exubera partners were allegedly left to find out the product was being scrapped through a press release.
Danish firm Pronova BioPharma announced this morning that it is to double manufacturing capacity for its marine-derived active pharmaceutical ingredient (API), following increased demand for its omega-3 based drug.
Novartis has received US approval for its osteoarthritis pain gel - the first for a topical prescription treatment for the indication.
King Pharmaceuticals last week announced that it would be cutting 20 per cent of its workforce after the US Court of Appeals reversed a previous court ruling and invalidated a patent covering the firm's blood pressure drug, Altace (ramipril).
The European Medicines Agency is prejudiced in favour of big pharma and EU drug regulations need an overhaul, a new report says.
In-PharmaTechnologist.com brings you a selection of other headlines from the pharmaceutical manufacturing industry.
Roche heard early this morning that the European Commission (EC) has decided to reinstate the marketing authorisation for the company's HIV drug, Viracept (nelfinavir), but countries outside the EU have yet to make a final decision.
The use of honey as a wound healer is making a comeback and according to a new report surgeons should be considering the kitchen pantry as an alternative to the drugs cupboard.
With yesterday's perhaps unsurprising news that Pfizer has cut its losses and pulled out of the inhaled insulin market by dropping Exubera and giving up on second generation devices, the world's biggest pharma firm is in the process of scrabbling to get back on track and reaffirm its position at the top of the tree.
Pfizer revealed today that it is abandoning its once-touted blockbuster Exubera, ending months of speculation as to whether the fledging world-first inhalable insulin would sink or swim in the fierce waters of pharma.
LabTechnologist.com brings you its periodic update of recent product releases, with additions from Activotec, Applied Biosystems / MDS Sciex, FEI, Invitrogen, Mettler Toledo and Torrey Pines.
Agilent and BioTrove are collaborating to deliver ultra high-throughput sample preparation and mass spectrometry (MS) systems to speed the analysis of in vitro assays used in drug development.
Three big industry names have been busily bolstering their pharma logistics clout: Thermo Fisher Scientific, UPS and Kuehne+Nagel.
Pfizer's unprecedented move to network with physicians online has been described as a 'watershed moment' for the pharmaceutical industry by the chief executive of the social networking site Pfizer has joined to.
A new report has outlined a series of recommendations for government policymakers to help mitigate the potential risks of the burgeoning synthetic genomics area.
French firm Diatos has created a second generation irinotecan cancer therapy using its patented peptide-based drug delivery system, coming up with a drug that has greatly improved efficacy and safety profile compared to current irinotecan drugs such as Pfizer's Camptosar.
Novartis has turned in its results for the first nine months of the year, with income gnawed at by generic competition and product suspensions, but still claiming record earnings helped along by divestment gains.
A new solid-state proton NMR (nuclear magnetic resonance) technique has been developed that can quickly determine polymorphism of active pharmaceuticals within tablet formulations.
Swiss pharmaceutical and logistics company Galenica is to acquire Canadian pharmaceutical company Aspreva Pharmaceuticals for $915m (€645.2m).
Agilent and BioTrove are collaborating to deliver ultra high-throughput sample preparation and mass spectrometry (MS) systems to speed the analysis of in vitro assays used in drug development.
A worldwide growth in the sales of pharmaceutical bottles, and in the pharma sector in general, has had a positive impact on packaging company Gerresheimer's financial results.
ViRexx, Aesica, Velcura Therapeutics, Helix BioPharma and Avalon Pharmaceuticals have all had people on the move in the world of pharmaceutical manufacturing.
Sucking a lollipop before having an endoscope placed down your throat is looking like the sweet treat for pain relief, according to new research.
INC has bagged local development funding that could be worth nearly $15m (€10.5m) for the firm over a number of years.
Microbix Biosystems, PacificGMP and Insulet have all recently announced new contract manufacturing news.
Growing demand has prompted tableting specialist Meldex International, formerly BioProgress, to launch a new sales and distribution hub in Germany, with the UK firm also announcing a new manufacturing contract for its XGel film.
Epicept's ASAP screening platform examines levels of a cell 'executioner' in order to get its cancer drugs into the clinic faster.
The ten winners of the European outsourcing awards for 2007 were finally unveiled at the recently-held CPhI trade show in Milan.
Researchers from Wyeth Research's Biological Technologies division have described how the use of a titania-affinity enrichment step can aid in the discovery of post-translational protein modifications.
LabTechnologist.com brings you its periodic round up of industry news, with developments at Affymetrix Labs, AlphaSniffer, Corning, DNAPrint Genomics, Illumina and Rules-Based Medicine.
Pfizer has gone where no pharmaceutical company has gone before - a social networking website.
The US is woefully lagging behind the EU when it comes to approving biosimilars, a new report says.
Drug formulation and delivery specialist Orexo has decided it has had enough of improving established drugs and wants to develop its own, so has bought speciality pharma firm Biolipox.
Roche announced its third quarter financials today, with its portfolio of oncology products such as Herceptin (trastuzumab) and Avastin (bevacizumab) performing strongly, and helping off-set the massive 60 per cent drop in Tamiflu (oseltamivir) sales.
Normally, they are green, sort of spongy and found in dank nooks and crannies - but mosses have now been designed as therapeutic protein producing factories and are being implemented on a grand scale.
Following the shaky moment Crucell experienced last month after the failure of Merck's HIV drug, share prices had a healthy boost this morning on the news that MedImmune will be collaborating with the Dutch firm to develop new antibodies for hospital acquired infections.
An Indian firm has taken over the contract biologics manufacturing business of German corporation Siegfried.
As biologic drugs become ever more prominent, Avecia Biologics is winning plaudits for its advanced protein expression system pAVEway, gaining recognition from international industry experts and investing to meet increased demand.
Improving the technology infrastructure of drug development could save the industry hundreds of millions of dollars, according to a new US government study, with the ultimate winners being patients.
Boehringer Ingelheim has been forced to announce the planned closure of a UK manufacturing site as a result of pricing pressures that mean the firm is unable to produce unit dose vials (UDVs) at the site cost-effectively.
There have been a few changes in the top ten employers according to leading journal Science's annual survey of the best companies to work for in the biotech, biopharma, pharmaceutical and related industries.
In-PharmaTechnologist.com brings you a selection of other headlines from the pharmaceutical manufacturing industry.
Several big drug-makers are voluntarily recalling some of their cough and cold products for under-two-year-olds in the US as a precautionary measure against overdosing on the drugs.
The first vaccine for travellers' diarrhoea is looking promising after the announcement of Phase II results.
Thermo Fisher Scientific has acquired micro-volume UV-Vis (ultra violet visible) instrument manufacturer NanoDrop Technologies for an undisclosed amount.
LabTechnologist.com brings you a round up of product news, with developments at Beckman Coulter, Bruker, GE Healthcare, Invitrogen, PerkinElmer, Promega, Sigma-Aldrich, ThalesNano and Thar Instruments.
Professor Gerhard Ertl of the Max-Planck Society in Berlin, Germany, has won the Nobel Prize for Chemistry on his 71st birthday for his 'groundbreaking studies in surface chemistry'.
UCB is a wee bit excited after the opening of its newly expanded Irish facility, which will manufacture the company's overactive bladder drug, anticipated to be launched within the next two years.
Emergent BioSolutions is on the path to finding gold with its typhoid vaccine following positive results in a Phase II trial.
Researchers have developed a new microfluidic device that enables high-throughput (HT), cell-free protein synthesis for genomic and proteomic functional analysis.
Italian firm Cosmo Pharmaceuticals today announced a licensing agreement with Ferring for its reformulated budesonide product, predicted to be the first oral corticosteroid for ulcerative colitis approved worldwide.
Avecia Biologics has signed a development and manufacturing deal with US firm BaroFold, making use of the company's protein processing technology to produce its lead interferon-based multiple sclerosis (MS) candidate.
Indian contract formulations specialist Indoco has been actively angling itself to compete more heartily in the western market.
US-based contract manufacturer AMRI has been busily embracing India with the purchase and construction of infrastructure to cement itself in this popular location, delegates heard at this year's CPhI in Milan.
China is one of the best destinations to outsource preclinical work, delegates heard at this year's CPhI trade how in Milan.
Two manufacturers launched their docetaxel products at CPhI last week, each trying to stake their claim in the market in anticipation of patent expiries on Sanofi-Aventis' Taxotere (docetaxel) towards the end of the year.
Forget the washing up, the sponge could soon be used to deliver drugs - but on the nanoscale.
UK-based GE Healthcare is introducing nine new product lines for biopharmaceutical production.
GlaxoSmithKline, Pfizer, Nastech Pharmaceutical Company, Covalon Technologies and Invivi Technologies have all had people on the move in the world of pharmaceutical manufacturing.
There have been more calls this month to tighten regulations on pharmaceutical ingredient suppliers in the wake of the recent safety concerns emanating from low-cost regions such as China and India. However, despite having recently established a dedicated 'China Taskforce', a major EU chemicals consortium insists that it has nothing against the region or its manufacturers.
LabTechnolgist.com brings you a round up of recent industry news, including developments at Asuragen, bioMerieux, Caliper, Dolomite, IDBS, Perlegen, Phytronix, Porvair, Sigma-Aldrich and Thermo Fisher Scientific.
Dutch chemicals and excipients distributor Univar has hooked up with US manufacturer Innophos to provide the EU pharmaceutical market with its entire portfolio of excipients, helping to fill the gap left by the departure of Rhodia from the phosphate market.
Denmark-based Bavarian Nordic has received an advance payment of $50m (€35.4m) from the US Government for meeting milestones in one of its smallpox vaccine supply contracts.
UK-based TeraView has had its tablet imaging technology backed by the US Food and Drug Administration (FDA), following a study by the regulatory agency.
India's Dr Reddy's Laboratories has become the first company in the world to receive a new verification mark for two of its products, it was announced last week at the CPhI trade show in Milan.
German researchers have shown 3D cell structures better resemble tumour phenotypes than traditional cultures, suggesting they will make better models for testing new anticancer agents.
Sales of laboratory products in Germany have recovered from a 'stagnant period' between 2001 and 2004 to reach a record €5.3bn in 2006.
Constructive Biology expert, Codon Devices, has opened a European subsidiary in the UK to support the rapid growth of the advanced gene synthesis and protein engineering markets.
US drug discovery firm BioProcessors has unveiled a new range of cell culture services to assist in biopharmaceutical process development.
As an increasingly desperate pharma industry strives to fill drug pipelines, the sector has, for the first time, topped a poll of which industries spend the most on research and development.
The European Fine Chemicals Group (EFCG) has called for stricter regulation of pharmaceutical excipients in a bid to prevent substandard and potentially dangerous products ending up in medicinal drugs.
Swiss pharma Novartis has got the thumbs up from the EU for its once-yearly treatment for postmenopausal osteoporosis.
The Generic Pharmaceutical Association has questioned a new US Food and Drug Administration (FDA) initiative as possibly "throwing money down the drain".
Three more individuals have been sentenced following last month's exposure of the largest counterfeit drugs conspiracy ever to be encountered in the UK.
Denmark's Novo Nordisk, could be on the verge of selling off its engineering division, if reports in the local business daily Borsen are to be believed.
Amgen has announced the 'indefinite postponement' on plans for its $1bn (€0.71bn) manufacturing facility in Cork, Ireland, following further navel gazing by the company.
GlaxoSmithKline is seeking prequalification status from the World Health Organisation for its new cervical cancer vaccine, Cervarix, in a bid to speed up its availability to developing countries.
An ingredient in chillies could form the basis of a new pain management formulation without creating numbness, researchers in the US have found.
LabTechnologist.com brings you its periodic round up of product news, with releases from Harvard Apparatus, Invitrogen, Mettler Toledo, Millipore, Syrris, Thermo Fisher Scientific, Velocity 11 and WLD-TEC.
German pharma firm Bayer is currently discussing with Indian company Biocon about a potential deal that would include the co-development of new biologics with an outsourcing element, according to Biocon.
Horiba Jobin Yvon's protein interaction analyser, which can analyse up to 400 biomolecular interactions in 10 minutes, made its UK debut at the L.A.B. show on Tuesday.
The excessive use of a popular influenza drug, and the associated build up of its waste in the environment, is heightening the risk of creating viruses in nature that are resistance to the therapy.
Finland-based Atacama Labs has launched its proprietary technology system for developing solid oral dosage forms.
The era of human polyclonal antibodies has dawned as efforts get underway to produce the next generation therapeutics in transgenic chickens.
FMC BioPolymer has been forced to raise the price of its pharmaceutical grade cellulose by up to eight per cent to meet market pressures.
The US Food and Drug Administration (FDA) has sent a letter to Genzyme to warn it about manufacturing issues at its biomanufacturing facility in Lyon, France.
Forget diamonds, a new vaginal gel contraceptive could be the 21st Century girl's new best friend with the ability to be applied up to 18 hours before a naughty rendezvous.
Investors in Bristol-Myers Squibb were in a frisson of excitement earlier this week as speculation mounted - not for the first time - that the firm could soon become the target of a major pharmaceutical acquisition.
SAFC has announced its plans to build a new high potency conjugation suite at its Missouri manufacturing plant in order to target pharma clients developing novel anti-cancer drug conjugates.
Mylan, Momenta Pharmaceuticals, VaxGen, Osprey Pharmaceuticals, Bioject Medical Technologies, and Othera Pharmaceuticals have all had people on the move in the world of pharmaceutical manufacturing.
US regulators have found a new 'hundreds and thousands'-like drug treatment to be very palatable.
The US Food and Drug Administration (FDA) has been called into question again after the release of a damning report, this time suggesting the agency is inadequate in its safety monitoring of clinical trials.
LabTechnologist.com brings you a round up of recent industry news, with developments at Affymetrix, Celera, deltaDOT, Eksigent, Farfield, Nanogen and Olympus UK.
Applied Biosystems (ABI) has exclusively licensed Olink Bioscience's proximity ligation assay (PLA) technology that enables the correlation of gene and protein expression data.
TheraKine and Capsulution NanoScience are collaborating to develop new drug delivery systems to aid in the treatment of serious eye diseases.
Pharmaceutical companies not only have to face the consequences of a burgeoning counterfeit drug black market but have to contend with the theft of their own manufactured drugs for illicit uses, according to a US consumer advocacy group.
The merger between Mitsubishi Chemical Holding's pharmaceutical unit and Tanabe Seiyaku has been completed and the new entity is looking to expand its presence outside Japan and create a more efficient R&D and manufacturing machine.
Discovery Laboratories could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market as it has finally resolved the manufacturing issues that have plagued the product for months.
A major shareholder in Bioenvision could seriously compromise the biotech company's proposed $345m (€242m) takeover by Genzyme as it is preparing to vote against the merger arguing the offer is too low.
Baxter, LifeCyte, arGentis and Pfizer CentreSource have all recently announced new contract manufacturing deals.
DSM has announced the conclusions for the company's complete overhaul as it accelerates the shift to a life sciences and materials sciences company.
Novartis's potential Type II diabetes blockbuster has been given the green light in the EU after receiving approval.
Novartis has hooked up with the Massachusetts Institute of Technology (MIT) to fund a project aimed at 'revolutionising' pharmaceutical manufacturing and doing away with traditional batch-based production techniques.
Pfizer will appear this week in a Nigerian court to face allegations that it caused the death of Nigerian children over a decade ago when it conducted a clinical trial of its meningitis drug Trovan (trovafloxacin) in the country.
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