The Challenge of Change - Managing Excipients Control
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A new study linking aspartame with various cancers has opened the door for interpretation as it calls into question other studies which have suggested the sweetener is anything but dangerous.
YM BioSciences is the latest company to join the race in developing innovative pain relief products with its Investigational New Drug (IND) application for inhalable fentanyl cleared by the US Food and Drug Administration (FDA) this week.
A US software solutions provider has signed up Merck & Co for the global installation of a system which will bring together regulations and manufacturing.
Genzyme has opted to deploy Werum's PAS-X management executions system (MES) software in its Waterford, Ireland, plant.
Bespak, one of the two contract manufacturers of Pfizer's inhaled insulin Exubera, has announced it will cut a "significant" number of jobs as sales of the once-touted blockbuster are falling short of expectations.
Waters has combined its award winning Synapt MS with a MALDI ionisation source to broaden the number of applications the instrument can be used in - including MALDI imaging.
LabTechnologist.com brings you its weekly round-up of new product releases, with news from ABB, FEI, Integra, Porvair, Radleys and Tecan.
Researchers have developed a new 'supermacroporous cryogel' bioreactor for the long term continuous production of monoclonal antibodies (mAbs) that outperforms T-flask batch cultivators.
Ireland has successfully established itself as a hub for the pharma and biotech industries, and the trend to invest in high value-added activities on the green isle shows no sign of slowing, according to Ireland's Industrial Development Agency (IDA).
Merck Serono's revised formulation of its top seller Rebif (interferon beta-1a) that offers improved tolerability for multiple sclerosis sufferers has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
Canadian biotech firm SemBioSys Genetics has presented an update on its project to promote plant-derived recombinant human insulin on a commercial scale, expecting to hop directly to Phase II trials early next year.
The Oman Health Ministry's Department of Communicable Disease Surveillance and Control (DCDSC) is considering chucking the traditional needle and syringe immunizations as it invests in a study with a needle-free system.
A new living cell-based skin graft technology is being hailed by its inventors as a 'clinical breakthrough in regenerative medicine' following early-stage trial results, published yesterday.
SkyePharma's novel controlled-release sleep therapeutic has been licensed by Somnus Therapeutics in an exclusive worldwide development and commercialisation deal.
With a number of companies competing in the race to develop the first oral treatment option for multiple sclerosis, UCB and Biogen Idec's oral version of the infamous Tysabri has entered Phase II trials.
Orphan drug Soliris (eculizumab) has been approved by the European Commission and marks the first therapy for a rare and life-threatening blood disease.
PTC Therapeutics, Encysive, Novagali Pharma and Insmed have all had people on the move in the world of pharmaceutical manufacturing.
Procter & Gamble (P&G) has announced its intention to outsource the active pharmaceutical ingredient (API) R&D and manufacturing work undertaken at one of its US factories, with resultant closure of the site and job losses.
Bioxel Pharma is the latest company to submit a Drug Master File (DMF) to the US Food and Drug Administration (FDA) for docetaxel in the lead up to the patent expiring on Sanofi-Aventis' version of the cytotoxic chemical at the end of this year.
US biotech company Alexion has been given the green light by European regulators to market its new orphan drug Soliris (eculizumab) - the first therapy to be approved under the EU's new fast-track review process.
Pharma giant Roche has gone public in its fight to acquire tissue-analysis instrument and reagent expert Ventana Medical Systems for $3bn (€2.2bn).
Granules India, Dalton Pharma Services, Polymun, and CMC Biopharmaceuticals have all announced new contract manufacturing deals this week.
LabTechnologist.com brings you its periodic round up of industry news with developments at Applied Biosystems, MFIC, Oxford Gene Technology, PerkinElmer and Syagen.
A new software system to streamline manufacturing operations has hit the market and promises to be the pharmaceutical industry's new best friend.
Dutch researchers have developed a sensor array for monitoring fermentation in microwell plates to aid bioprocess design and scale-up.
Research into new tools that will remove the need to use animals in medical research has received a £240,000 (€356,000) boost at the University of Nottingham.
Eli Lilly's once-daily version of its erectile dysfunction treatment Cialis (tadalafil) has been granted approval by the European Commission, giving it a head-start over other ED treatments that are taken on an as-required basis.
A long-awaited and in some cases, long-feared, regulatory pathway for the US Food and Drug Administration (FDA) approval of follow-on biologics is now closer to fruition.
A European regulatory committee has recommended the approval of three generic versions of Johnson & Johnson's (J&J) anaemia blockbuster Eprex in what could lead to the market launch of new "biosimilars" by the end of the year.
Microtest Laboratories and Texcel Medical have teamed up to offer biopharma firms services to help them overcome the hurdles of developing "combination products" - a fast-growing market.
Despite the popularity of transgenics and the potential it is seen to hold for the future of biopharmaceutical production, Viragen has decided to drop development of its OVA system - therapeutic protein production in transgenic hen eggs.
Danish drug-maker Novo Nordisk is continuing in its drive to expand its manufacturing facilities around the world; the latest being in the US.
Another company has jumped on the band wagon to find an innovative way to increase the half-life of therapeutic proteins.
Genzyme has put pen to paper on a licensing deal for Ceregene's Parkinson's drug, as a rival gene therapy for the same disease shows promise in initial clinical trials.
In the latest episode of the Viracept contamination case, the drug is now at risk of losing its marketing authorisation across Europe while the dangers posed by the chemical contaminant are established and manufacturer Roche rectifies its manufacturing mistakes.
The International Society for Pharmaceutical Engineering (ISPE) has published its latest industry guide, a revised edition of its manual providing industry guidance on facilities and production of active pharmaceutical ingredients (APIs).
Shire Pharmaceuticals has acquired exclusive development rights to a new transdermal patch product for Attention-Deficit/Hyperactivity Disorder (ADHD), adding a further novel product to its ADHD portfolio.
LabTechnologist.com brings you its weekly round of new product releases with new offerings from Asynt, Genevac, Huber, Jasco, Micronic, Olympus, Velocity11 and Viscotek.
Thermo Fisher Scientific has opened a new RNAi Discovery and Therapeutics Services Laboratory to help pharmaceutical companies in their quest for new drugs.
The contract manufacturing business that Cardinal Health sold earlier this year has just been launched as an independent operating company rebranded as Catalent Pharma Solutions.
US-microfluidics expert Fluidigm has launched a new dynamic array for its BioMark instrument that increases the efficiency of PCR (polymerase chain reaction) genotyping while reducing the amount of costly equipment and reagents needed.
German biotech company, Greenovation has received a broad ranging US patent for its unique moss-based biopharmaceutical production technology.
Novartis' has received US approval for its single-tablet combination of the world's two most popular hypertension drugs, taking advantage of rival patent expiries and shoring up its portfolio.
At a time when single-use manufacturing equipment is riding on a surge of popularity, in-PharmaTechnologist.com talks to Vijay Singh of GE Healthcare's newly acquired Wave Biotech unit about the impact disposables will have on the future of personalised medicines.
Modigene has made inroads into its development of long-acting proteins through the use of its Carboxyl Terminal Peptide (CTP) technology.
The little sister of the respirator protecting against viruses and air pollution has blown in, and its makers are plugging the innovation as a "breakthrough" in pulmonary drug delivery.
CuraGen is shutting its doors on its Connecticut pilot manufacturing facility in a bid to reduce manufacturing capabilities and to focus more on the company's clinical pipeline.
Despite a lift of the ban on biological sample transportation out of Russia, the country's clinical research industry is still in the dark on the new rules to control export of such materials.
Patheon is teaming up with formulation development services firm Senopsys to offer pharma companies combined services to test and improve drug flavour.
European and US regulatory bodies have revamped their relationship to ease administrative burdens and improve communication, as well as implementing new measures directed specifically at paediatric drug products.
Plexxikon, Oculus, MedImmune and Pharmatech Associates have all had people on the move in the world of pharmaceutical manufacturing.
A novel super adjuvant is to be put to the test as a new seasonal flu vaccine enters Phase I trials, and is expected to offer enhanced immunity and broader protection than other vaccines on the market.
The US Government is not sneezing at the potential for an influenza pandemic and has awarded two new vaccine manufacturing contracts to keep the sniffles at bay.
LabTechnologist.com brings you its periodic round up of industry news with developments at Agilent, Biotage, Chenomx, Oxford Gene Technology, Phenomenex and Sigma-Aldrich.
Roche Diagnostics has strengthened its position in the genomics field with the acquisition of DNA microarray expert NimbleGen in a deal worth $272.5m (€203m).
Researchers have developed a new way to deliver drugs into the brains of mice, which could herald a new dawn for the sufferers of brain diseases such as Alzheimer's.
US firm Aptuit has announced it will invest $100m (€75m) in India-based Laurus Labs to form a new joint venture - just a few months after splurging a similar amount to expand its capabilities.
Swedish researchers have developed a method of separating a continuous flow of (bio)particles based on their size and density using acoustic forces.
Dutch ingredients firm DSM has announced plans to carve out its anti-infectives business and boost its presence in Asian markets following a review of the active ingredient unit.
With the world's largest medical study rolling out across the UK, LabTechnologist.com explores the problems of biobanking with Dutch biosample storage experts, Micronic.
In a bid to maintain its position in the human growth hormone (hGH) market and offer new solutions to patients, Merck-Serono has teamed up with a US firm to develop a novel growth hormone product that could offer significant dosing advantages.
Genmab and partner GlaxoSmithKline have reported clinical data showing that their antibody drug Humax-CD20 (ofatumumab) could be effective in rheumatoid arthritis as well as cancer.
US researchers have developed a three part screening process to find new cancer genes and used it to identify a new gene associated with about a third of all breast cancers.
Cosmo Pharmaceuticals is cementing its place in the inflammatory bowel disease (IBD) drug market with eight new drugs in various stages of reformulation using the company's cutting-edge MMX technology, the company announced recently.
Following last year's contaminated glycerin poisonings in Panama and last month's FDA guidance, US-PharmaTechnologist.com takes a look at the implications of testing for the excipient glycerin in the pharmaceutical supply chain.
Several top pharmaceutical companies have had their business practices scrutinized by a benchmarking company to help provide executives with ways to stay out of trouble with regulatory authorities.
LabTechnologist.com brings you an exclusive interview with Chris van Ingen - the president of Agilent's Life Science and Chemical Analysis (LSCA) division.
LabTechnologist.com brings you a round up of some of the latest product releases with new offerings from Agilent, Applied Biosystems, ESA Biosciences, Illumina, Mettler-Toledo and Syrris.
ThalesNano Nanotechnology has launched a new version of its H-Cube flow reactor for use in higher education laboratories - the H-Cube Tutor.
Just over a week after Roche was forced to initiate a Europe-wide recall of HIV drug Viracept (nelfinavir), in-PharmaTechnologist.com considers the contamination case and the pharmaceutical processes blamed for the incident.
US pulmonary drug delivery specialist Respirics has decided to sell its assets relating to its MD Turbo product to focus on its Acu-Breathe powder inhaler platform.
Several major manufacturers have pledged millions of doses of H5N1 vaccine to go towards a global stockpiling scheme initiated by the World Health Organization to protect against the threat of an avian flu pandemic.
The loss of a significant contract has left West Pharmaceutical Services wielding the axe at one of its UK facilities.
KV Pharmaceutical has snapped up a specialist coatings firm that it hopes will enhance the company's drug delivery product pipeline.
Critical Therapeutics is developing a new injectable formulation for the treatment of asthma, and is the latest company to use Captisol technology to achieve it.
Lonza is building a new plant in its home country to become the only contract manufacturer with large-scale capacity for making highly potent active pharmaceutical ingredients (APIs).
Relaunching pharmaceutical products in a bid to preserve an earlier product's existing market share and maintain revenues is a common tactic in the pharma industry, but, as a recent report notes, kicking off development plans early can make all the difference.
Solvay today announced plans to increase production of ultra-pure soda ash at it Dombasle, France, site to meet the growing demand in the pharmaceutical industry.
German researchers have developed a microfluidic device that greatly increases the efficiency of measuring the melting temperature of DNA double strands.
VaxInnate, Inspire Pharmaceuticals, Par Pharmaceutical and Progen Pharmaceuticals have all had people on the move in the world of pharmaceutical manufacturing.
Swiss drug maker Novartis today announced that it has gained EU approval for it new cell-based flu vaccine, Optaflu.
ImClone has been found guilty of intimidating a key witness in an ongoing patent infringement case with Repligen and the Massachusetts Institute of Technology (MIT), over its lucrative cancer drug.
Schering-Plough and Kurve Technology have signed a new agreement involving Kurve's nasal drug delivery device, which follows on the heals of a partnership formed between the two companies last year.
Taiwan looks to benefit from a new alliance with Canada-based ProMetic BioTherapeutics, which will provide a proprietary manufacturing process to extract plasma proteins for drugs.
JRS Pharma has entered into a collaboration with US firm CoreRX to develop co-processed active pharmaceutical ingredients (APIs) using JRS's high functionality excipient technology, Prosolv
LabTechnologist.com brings you its periodic round up of industry news from Biomatrica, Cogenics, Correlogic, Digilab, MDS Nordion, SuperArray and Sigma-Aldrich.
Applikon Biotechnology has launched a new bioreactor controller, the i-ControlXL, that has been designed to work with reactors of any size, from any supplier.
BioFocus DPI has released a new informatics system that can combine chemical and biological data from various sources to optimise protein kinase inhibitor candidate selection.
US researchers have developed a new technique that allows the identification of bacteria as well as differentiating between genetically similar species.
Pharmaceutical companies are actually set to benefit from reduced testing requirements now that the new European chemicals regulation is in place, however, some bulk manufacturers and ingredients suppliers could face increased burdens.
Novo Nordisk has inaugurated its new pilot plant for biopharmaceutical products in Denmark in its latest move to expand its presence in biopharmaceuticals.
UK technology expert The Technology Partnership (TTP) celebrates its 20th birthday this year with its focus on innovation stronger than ever.
After dismal second quarter results Patheon is stepping up its resolve for 'damage control' and indicated that further cutbacks at its problematic Puerto Rico plant are imminent.
Major packaging player Rexam this morning announced that it will be scooping up the plastics business of beleaguered firm Owens-Illinois in a deal worth almost $2bn (€1.5bn).
The fallout from a US Food and Drug Administration (FDA) probe continues to haunt MDS Pharma, dragging it into the red again during the second quarter.
Histological evidence of tumour destruction has confirmed the promise of Epeius Biotechnologies' Rexin-G as an effective targeted gene therapy platform for metastatic cancer.
Ipsen has cancelled its Phase III trial of its sustained-release formulation of triptorelin while it attempts to fine-tune the manufacturing process of the hormone therapy drug.
GE Healthcare has installed a new automation system at its global headquarters in Uppsala, Sweden, which is due to boost production of protein separation media at the site by 50 per cent.
While traditional cancer treatments currently have the lion's share of the market, a new wave of immunological and biotherapy treatments are set to take the industry by storm, predicts new market research.
Genzyme is expanding its manufacturing capabilities of thymoglobulin in France as it moves to meet the growing demand and future potential of the rabbit serum derivative.
The first ever non-steroidal anti-inflammatory drug (NSAID) to be delivered via the nose has been developed, and its makers are heralding it as "an important breakthrough in treating pain".
Applied Biosystems has entered into a four-year supply agreement with Repligen to receive recombinant Protein A.
LabTechnologist.com brings you a round up of some of the latest product releases with new offerings from Activiotec, Cyprotex, Bruker, Olympus, PerkinElmer and Varian.
Applied Biosystems (ABI) has started its early access program for its next-generation DNA sequencing system, SOLiD, as well as starting to take customer orders.
Biotech titan Amgen announced yesterday the acquisition of a small molecule developer - the second buyout of this type in less than a week.
Researchers from UCLA in the US, have created a new nanoparticle delivery system to allow water-insoluble drugs to be released into cancer cells.
A joint effort to develop a winning oral formulation for the treatment of multiple sclerosis (MS) has taken another step towards the finish line with initiation of Phase III trials for the novel laquinimod compound.
Roche has initiated a recall of its HIV drug Viracept (nelfinavir) right down to the patient level after finding evidence of dangerous contaminants in the tablets.
Siegfried Generics this week kicked off production at its new manufacturing facility in Malta making the most of the country's lack of pharma patents which gives the firm a head-start in producing generic pharmaceuticals.
The apparent inability of current analytical techniques to fully characterise complex biological drugs still stands in the way of easy approval pathways for 'biogenerics' or copies of off-patent brand name biologics.
UK's Intertek Pharmaceutical Services is expanding the range of its offerings with the acquisition of QTI, a US contract analytical laboratory.
IDBS look to speed up laboratory research by enabling more efficient knowledge transfer with its latest electronic lab notebook (ELN) suite, E-WorkBook 7.0.
Valeant Pharmaceuticals has announced that it has found a buyer for two of its manufacturing plants in a final move to complete the restructuring plans announced by the company last year.
Abbott is the latest pharmaceutical company to scoop up Dowpharma's exclusive protein-producing technology.
Sartorius has signed a non-exclusive licensing deal with Dutch biotech firms Crucell and DSM for the use of their PER C6 cell culture technology which could result in the creation of a new bioprocessing platform combined with disposable technology.
Scientists have successfully used ribozymes - considered by some to be the 'living fossils' of a time when life was based on RNA - to prevent the spread of HIV in the body.
The market's first non-interferon based drug for the treatment of multiple sclerosis (MS) can now be stored at room temperature for up to a month, following approval from US and EU authorities.
Bionovo, Somaxon Pharmaceuticals, Trius Therapeutics, Exelixis, AmerisourceBergen Corporation and Kindred Healthcare have all had people on the move in the world of pharmaceutical manufacturing.
An Italian firm specialising in novel drug delivery technologies is due to receive a lump sum of €1m following the successful development of a new formulation of a GlaxoSmithKline (GSK) drug.
Morphotek, CMC Biopharmaceuticals, Cobra Biomanufacturing, and Fraunhofer have all announced new contract manufacturing deals this week.
Morphotek, CMC Biopharmaceuticals, Cobra Biomanufacturing, and Fraunhofer have all announced new contract manufacturing deals this week, while Jubilant Organosys completed its US buyout.
A drug that holds the potential to 'significantly' improve the symptoms of rheumatoid arthritis (RA), rather than merely relieve the pain for the debilitating disorder, is one step closer to the market.
Guidelines for the safe and effective supply of seasonal and pandemic influenza vaccines have been finalized by the US Food and Drug Administration (FDA).
One week - that would be all the time needed to produce a new vaccine against an infectious disease outbreak, according to initial data from a novel vaccine manufacturing technique.
Denmark-based Bavarian Nordic has clocked up a whopping $500m (€371m) contract with the US government to supply millions of doses of smallpox vaccine.
DeltaDOT has been given a government grant to commercially develop a new tool to allow researchers to reduce dramatically the time it takes to weed out unsuitable drug candidates.
SPI Pharma has denied infringing Roquette Freres mannitol excipient patent and has claimed instead that Roquette's patent is invalid.
LabTechnologist.com brings you its periodic round up of industry news, with Qiagen agreeing to buy Digene, Roche Diagnostics settling a tax evasion investigation and agreements between Bio-Rad and Beckman Coulter, Waters and Rosetta Biosoftware, and Isogenica and Wyeth.
Thermo Fisher Scientific has introduced a range of powerful new mass spectroscopy products at the 55th ASMS Conference on Mass Spectrometry currently being held in Indianapolis, US.
Just weeks after announcing intentions to snap up biologics firm MedImmune, AstraZeneca has acquired DSM's old biologics manufacturing facility in Montreal, Canada, a site that's been gathering dust since it was mothballed by the firm last year.
European pharma group Ipsen is planning to shell out a hefty sum to upgrade its facilities in Dreux, France and bolster activities in strategic areas.
Amgen will strengthen its drug portfolio aimed at fighting renal disease after agreeing to acquire Ilypsa, a private biotechnology company which is developing a novel drug for the treatment of elevated blood phosphate (hyperphosphataemia) in chronic kidney disease (CKD) patients.
Execution, acquisition and integration stages are the three most important steps to master in order to make a successful acquisition deal, explained legal experts at a biotech conference in London last week.
In a bid to push manufacturers to reduce their greenhouse gas emissions, the UK government last week unveiled a proposal that could pave the way for "carbon footprint" labels on products.
Schreiner MediPharm, a leading manufacturer of 'intelligent' labels has chosen Datalase's flagship Packmark printing technique for its customers in the pharma industry.
The UK Department of Trade and Industry (DTI) has awarded £1.1m (€1.62m) to a consortium led by Cobra Biomanufacturing for a project applying the company's ORT-VAC technology to the development of oral vaccines for avian influenza and HIV/AIDS.
The European Commission has released figures showing that there has been a dramatic and concerning increase in pharmaceutical counterfeiting, with seizures in Europe hitting an all time high of over 2.5m items.
Switzerland-based Roche is helping African nations fight the AIDS epidemic by sharing its coveted saquinavir drug-producing technology with two more manufacturers in Ethiopia and Zimbabwe.
The stringent and controversial new law aimed at protecting consumers from unsafe chemicals, came into force on Friday.
Germany's Capsulution Nanoscience is tapping into Qiagen's molecular diagnostics expertise in a collaboration that will explore new diagnostic and therapeutic possibilities for cancer and other diseases.
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