Breaking News on Pharmaceutical Technology

Gene therapy skies grey again

Just as the biopharma industry was recovering from its hangover after negative clinical events in the gene therapy field, the death of a patient during a gene therapy trial last week puts a cloud in the sky for this promising area of research.

Risk management strategy progressing nicely

European pharmaceutical and medical authorities have announced their satisfaction on the progress being made with the European Risk Management Strategy (ERMS) following a meeting earlier this month.

Sanofi's SoloStar hits US market despite patent suit

Sanofi-Aventis' disposable insulin pen SoloStar has been launched across the US for use with the company's 24-hour basal insulin Lantus (insulin glargine), despite patent infringement claims emanating from fellow insulin pen manufacturer, Novo Nordisk.

The fine line between antibody yield and process throughput

UK researchers have developed a computer simulation to aid researchers find the optimum conditions for purifying polyclonal antibodies on affinity chromatography systems.

China continues steps toward drug safety reform

China continues to take steps toward drug safety reforms as it forges closer ties with US regulators and shuts down dodgy manufacturing plants.

Gerresheimer going strong

German packaging firm Gerresheimer has reported healthy first half financial results, boosted by a series of strategic acquisitions and favourable market conditions, with the firm's recent initial public offering promising to help keep the outlook rosy.

'Super Combination Traveler's Vaccine' looking promising

The concept of a "Super Combination Traveler's Vaccine" has come one step closer to reality with the initiation of a Phase II study on a single dose, oral typhoid fever vaccine.

MorphoSys pleased with financial results

German-based MorphoSys has a positive outlook for its antibody producing industry, despite the research antibody segment posting revenue 10 per cent below expectations in the six-month financial report released today.

TB booster vaccine enters Phase II

A new booster vaccine aimed to up the immune response against tuberculosis (TB) has entered Phase II trials in South Africa.

Biocon JV sets up in UAE

Indian biotech heavyweight Biocon has today announced that its joint venture with Abu Dhabi-based Neopharma has spawned new company NeoBiocon, operating out of one of Dubai's newest biotechnology parks.

Patent promise for oral insulin tablet tech

A novel drug delivery technology capable of delivering large molecules in oral tablet form is set to gain patent protection in a number of countries through an international patent treaty.

Contract manufacturing news in brief

Akorn, Dompé, Angel Biotech and Flamingo Pharmaceuticals have all made new contract manufacturing announcements this past week.

Rentschler in protein production expansion

Rentschler Biotechnologie has completed the first phase of a €50m expansion of its biomanufacturing capacity with the launch of two new bioreactors aimed at making protein-based drugs for biopharma clients.

Frustration for GPC oral cancer drug

GPC Biotech was dealt a blow this week as an advisory committee recommended that regulatory bodies should hold off on approval of a novel oral formulation of a platinum-based cancer drug.

Novel soft mist COPD inhaler set for EU

A novel spring-powered inhaler system to deliver the blockbuster COPD (chronic obstructive pulmonary disease) treatment Spiriva (tiotropium) has successfully completed the EU approval process, paving the way for its introduction into the EU market.

Don't trust 'Old Faithful' when pipetting hot liquids

Artel's extreme pipetting expedition team went to Yellowstone National Park, US, where they found that pipetting hot or cold liquids can cause delivery volume errors of up to 37 per cent.

RFID set for explosive growth

The use of radio frequency identification (RFID) technologies in the healthcare industry is set for explosive growth over the coming years as teething problems from its formative years are overcome.

World pharma packaging set for solid growth

Worldwide demand for pharmaceutical packaging is set to grow steadily over the coming years growing to over $30bn (€21.7bn) by 2011, according to a new report published this week.

First dissolution-focused CRO launched

Lab equipment specialist Sotax has announced the creation of a new contract research organisation (CRO) focused exclusively on dissolution testing services.

Vivalis cell lines show MAb production power

French firm Vivalis has announced the first data evaluating its proprietary EBx cell lines for the production of monoclonal antibodies (MAbs), with initial results suggesting high cytotoxic properties in the resultant MAbs.

Nabi splits into two units; cuts 5% staff

Nabi Biopharmaceuticals has announced the creation of the second of its two new business units, Nabi Pharmaceuticals, a month after spinning off its Biologics segment.

MS drugs boost Biogen Q2 results

Biogen Idec has announced healthy financial results for the second quarter of the year, boosted by high sales of its three leading drugs.

Pharmaceutical manufacturing: people on the move

Roche, Alexza Pharmaceuticals, WuXi PharmaTech, Ambrx and NovaDel Pharma have all had people on the move in the world of pharmaceutical manufacturing.

Disappointment for Biovail bupropion plans

Biovail has this week sought to reassure its investors after the news that US regulators issued the company with a Non Approval letter for its new bupropion salt anti-depressant.

Xcelience expands as contract formulation biz booms

Formulation services firm Xcelience has announced it is expanding its headquarters in Tampa, Florida with the acquisition of a new building in a bid to cope with growing customer demand.

ABI launches new miRNA expression arrays

Applied Biosystems (ABI) has launched its TaqMan microRNA (miRNA) assays in array format to help researchers search for miRNA biomarkers more efficiently from smaller samples.

Tamiflu caps for kids get EU thumbs up

Roche has received a positive opinion from EU regulators recommending the approval of low-dose capsules of the blockbuster flu drug Tamiflu (oseltamivir), providing a more convenient dosage form for children.

The future of oral controlled release

The field of oral controlled release drug delivery is constantly evolving and developing, allowing ever more precise and tailored delivery profiles for pharmaceutical drugs.

Codexis expands portfolio with BioCatalytics buyout

Biocatalysis expert Codexis has acquired BioCatalytics for an undisclosed amount to strengthen its off-the-shelf biocatalyst portfolio and give itself a larger 'window to the market'.

Cash injection for Dengue fever vaccine

US biotech firm VaxInnate has been awarded a lump sum from the National Institutes of Health (NIH) to support the development of the company's tetravalent Dengue fever vaccine.

Novozymes awarded for animal-free innovation

Danish firm Novozymes has been honoured by animal rights organisation PETA for its efforts to provide animal-free bioprocessing methods aimed at cutting animal testing during drug development.

MHRA stalls cannabis-based MS drug

A UK firm developing cannabis-derived multiple sclerosis (MS) treatments has decided to pull an EU application for its lead candidate Sativex, following demands by UK regulators for additional data in support of the treatment.

Three hits for Novartis

Thursday was a good day for Novartis as EU regulators issued positive opinions on no less than three of the company's drug products, for the treatment of Alzheimer's, osteoporosis and Type II diabetes.

CABB catches SF-Chem in chlorine combo

German speciality chemicals firm CABB has scooped up Swiss company SF-Chem in a deal set to create a leading European supplier of chlorine and speciality intermediates.

Sanofi's US facility completed

Sanofi Pasteur has completed construction of its new facility in the US in a bid to meet an anticipated demand for seasonal influenza vaccine in the future.

Gardasil rival set for EU approval

GlaxoSmithKline's cervical cancer vaccine, Cervarix, has received a positive opinion from the European Commission for Human Medicinal Products (CHMP), bringing a competitor to Merck & Co's dominant Gardasil vaccine a step closer.

Increasing plasmid production efficiency

Swiss researchers have developed a method that combines bacterial capture, lysis and the purification of plasmid DNA to improve industrial-scale bioprocesses.

Contract manufacturing news in brief

Xcellerex, QSV Biologics, IntegrityBio and Indoco Remedies have all made new contract manufacturing announcements of late.

Sanofi still waiting on insulin pen accusations

Despite numerous media reports of an impending patent infringement suit, Sanofi-Aventis has yet to formally hear anything from plaintiff Novo Nordisk, who claims the French firm's SoloStar insulin pen violates patents covering its own insulin pen products.

Nanotechnology - or is it?

At last week's Controlled Release Society annual meeting, an industry analyst looked at nanotechnology and its increasingly prominent role, but noted that much of what is touted as nanotechnology actually falls outside the nano-scale.

FDA draft guideline on ICH Q10

The US Food and Drug Administration (FDA) has released a draft guideline document outlining a model for implementing the International Conference on Harmonization's (ICH) Q10.

Study pushes conventional envelope on bioprocessing

The first study comparing traditional and optical sensors in cell culture has been published and the authors are heralding it as a potential paradigm shift in the realm of bioprocessing.

The 'global disaster' of fake internet pharmacies

Fake internet pharmacies are a growing "global disaster" with increasingly dangerous consequences, pharmaceutical industry figures say.

'No-touch' testosterone therapy proves positive

Australian drug delivery specialist Acrux has reported positive results in Phase II trials of its innovative under-arm lotion formulation for testosterone replacement therapy.

Viral vs. non-viral: The debate

At a packed out session at last week's Controlled Release Society meeting in the US, two experts battled it out to win one of the key debates in gene delivery: which is superior - viral or non-viral delivery?

Acambis' universal vaccine enters the clinic

UK firm Acambis has announced that its universal influenza vaccine candidate has entered Phase I trials, hoping to prove a key weapon in the fight against pandemic flu and last-minute production panics.

IDT simplifies miRNA discovery with miRCat launch

Integrated DNA Technologies (IDT) has launched a new kit for cloning libraries of small RNAs from any primary RNA source to enable the discovery of new small RNA molecules.

Contracts awarded in fight against biological threats

UK's deltaDOT, along with US firms Xcellerex, Dowpharma, BioPharm Services, Neugenesis and SRI International, have all been given key contracts by the US Defense Advanced Research Projects Agency (DARPA) to jointly accelerate emergency protein and vaccine manufacturing.

People on the move: pharmaceutical manufacturing

Biomira, Isolagen, Pharma-Olam International, Hyaluron and WuXi PharmaTech have all had people on the move in the world of pharmaceutical manufacturing.

Weekly Comment

Informed consent 'not up to scratch'

A recent survey of clinical trial participants in the US has revealed worrying signs that the informed consent process is 'not up to scratch'.

Biocon targets global cell culture market

Biocon is targeting the global cell culture market with the production of pharmaceutical-grade insulin as a potent growth factor.

Canadians get Naprelan

Canadians finally have access to the controlled-release formulation of naproxen sodium, which has been on the US market for more than 10 years for the management of osteoarthritis and rheumatoid arthritis.

VGX strengthens its plasmid position

US biopharmaceutical company VGX has strengthened its position in the plasmid DNA area with the award of two new patents covering the use and manufacture of plasmid DNA.

Cash injection for next generation conjugate vaccines

A Swiss firm working on a novel technology to vastly improve the production process for conjugate vaccines has announced a hefty cash boost to push forward development of its novel vaccine pipeline.

New test machines have the X factor

Productivity bottlenecks will be a thing of the past thanks to the new 'X' range of automated drug delivery testing machinery from UK-based firm Astech Projects.

Genentech displays strong growth again

In its second quarter of 2007, the world's number two biotech, Genentech, has again posted strong results.

Single-shot vaccines on the horizon

Research being carried out at the University of Utrecht in the Netherlands to replace standard vaccination schedules with a single-shot alternative could do away with the need for repeated jabs.

Safflower seeds sowing a protein-producing future

The humble safflower seed is looking like it could be the next protein-producing factory after SemBioSys Genetics produced commercial levels of an atherosclerosis treatment.

Expansion of allergen material facility

Biopol Laboratory is acting to meet the demand of sneezes, itchy eyes and running noses as it consolidates its five allergen production facilities into one main building in Idaho.

Needle-free injection device a winner

A new needle-free delivery system is taking a stab at the traditional needle and syringe after winning an award at the 2007 Medical Futures Innovation Awards.

Milking transgenic rabbits gets approval

A drug developed from the milk of transgenic animals is one step closer to being the second such drug on the market following a European thumbs up of its facilities, marking a significant move in the controversial drug development technology.

Best foam forward

An Israeli drug delivery firm is developing a new vaginal drug delivery system, making use of bio-adhesive foams to offer a more convenient and effective treatment option for women with gynaecological complaints.

Bridging the blood brain barrier

A novel technology set to overcome the challenges of the blood brain barrier is being developed in a bid to open the gates to previously unusable compounds for the treatment of central nervous system (CNS) disorders.

Generics set to boom

The European generics market is expected to boom to $35.9bn (€26.1bn) in 2013, according to a Frost & Sullivan report.

Outsourcing-Pharma.com special focus

Deja vu? Inyx tale parallels the past

As Outsourcing-Pharma.com continues to investigate the circumstances of the Inyx group's insolvency problems, it can be revealed that some of the senior management have been involved at a senior level in other firms that have also experienced financial breakdowns over the last few years, along with a small current venture that is also in financial trouble.

AeonClad the way to better drug, particle and device coatings

University of Texas at Arlington (UTA) spin-out has exclusively licensed plasma coating technology that could improve the controlled release of drugs and the biocompatibility of medical implants.

Improved culture media could advance stem cell research

Medicult, a Danish company best known for supplying products for use in fertility clinics, has developed a protein-free cell culture medium that could cut out problems associated with current media.

Separating the DNA from the blood

US researchers have developed a microfluidic device for purifying and concentrating DNA directly from blood samples that could speed up the use of genomics in clinical trials.

BioSante adjuvant looks promising

BioSante Pharmaceuticals' vaccine adjuvant is coming up trumps as vaccine manufacturers race towards finding the most efficient bird flu vaccine.

Endo Pharmaceuticals pain patch results painful

US-based Endo Pharmaceuticals has announced its pain relief patch has failed two Phase III trials.

Sigma-Aldrich to develop zinc finger binding proteins with Sangamo

Sigma-Aldrich is to collaborate with Sangamo BioSciences to develop zinc finger DNA-binding proteins to create knock-out cell lines and cell lines with enhanced protein production performance.

People on the move: Pharmaceutical manufacturing

Circassia, Affibody, Actavis, Sigma-Aldrich, and Abraxis BioScience have all had people on the move in the world of pharmaceutical manufacturing.

Servier sets up in Russia

France's largest independent drug company Servier has invested €40m in a new tablet producing factory in Russia to meet demand from the local market.

AlphaVax awarded grant for adjuvant technology

US-based AlphaVax has been awarded a $3.6m grant from a US Government health agency to develop a new adjuvant technology for vaccines.

First light for Angel after UK plant closure

Contract manufacturing organisation (CMO) Angel Biotechnology has penned a brand new deal with a Russian drug maker worth £450,000 (€664,000) just a few days after closing its struggling UK facility.

Weekly comment

China carries out execution on corrupt drug official

China has wasted no time in executing the first of its convicted corrupt former drug officials after his desperate appeal for life failed.

Outsourcing-Pharma.com special focus

Legal wrangling as Inyx units are deemed insolvent

Almost the entire international operations of specialty pharma contract manufacturer Inyx is facing insolvency and the company is locked in a legal battle with its principal financier.

Anticalins look promising

A new generation of therapeutic protein products has entered the biopharma scene and are proving more efficient than antibodies when using the same drug delivery systems.

Outsourcing-Pharma.com special focus

Charting the course of Inyx' downfall

With a knife-edge financial history of spiralling debts, exacerbated by continued borrowing, Inyx' recent insolvency problems are hardly surprising.

Shasun gets the thumbs up

Indian pharmaceutical manufacturing company Shasun Chemicals and Drugs has now got its eye fully on the US market after recent approval of its new formulation facility in Puducherry.

Noven acquires JDS to transform business outlook

Transdermal drug delivery expert Noven Pharmaceuticals is to buy JDS Pharmaceuticals in a deal worth $125m (€91m) to transform itself into a 'fully-integrated speciality pharmaceutical company'.

New scales outweighs the competitors

The end to botch-ups in batches is being heralded with the launch of a new set of scales.

Citric acid sensor is faster and cheaper

A new fluorescent chemical sensor can detect citric acid at low concentrations more rapidly and cheaply than current optical sensors, its developer claims.

Dishman to buy Solvay fine chemicals unit

Indian contract manufacturing organisation (CMO) Dishman Pharmaceuticals has announced its plans to buy Solvay Pharmaceuticals' fine chemicals and vitamin businesses for an undisclosed sum.

Alzheimer's patch gets stuck into US market

The first and only transdermal treatment for Alzheimer's disease has been approved in the US.

Helvoet burns rubber to stay ahead of injectables market

The world's number two manufacturer of rubber components for pharmaceutical products, Helvoet Pharma, has broken ground on a new facility that promises to double or even triple its capacity to supply the fast-growing markets for injectable biologics and cancer drugs.

China gets tough on manufacturers

China is cracking down on its pharmaceutical manufacturers with the State Food and Drug Administration (SFDA) revoking the production licenses of five drug makers since July, according to reports in the local media.

Ex-UCB unit sells for €0.8bn

Taminco, UCB's old intermediates and derivatives unit, has been sold at auction to European investment group CVC Capital Partners for €0.8bn.

Novo Nordisk gets transparent on bioethics

Biopharma company Novo Nordisk has launched a new website dedicated to bioethics which it claims is the first of its kind in the industry.

China to play starring role in AstraZeneca API outsourcing

AstraZeneca is planning to gradually withdraw from making its own active pharmaceutical ingredients (APIs) and will use China as the pinnacle of its new outsourcing plans.

Oxoid's new portable air monitoring device

Microbiology expert Oxoid has released a new active air quality monitoring device to help pharmaceutical companies prove that their clean areas are microbe free.

Circassia bags ex GSK chairman

Start-up UK biotech firm Circassia technology has had a major result in bagging 30-year industry veteran and former GlaxoSmithKline (GSK) chairman, Sir Richard Sykes, as its new chairman of the board.

Gel cap strength put to the test

A UK firm has introduced a new piece of kit for pharma firms to test how the contents of their hard gel capsules can affect the strength and stability of the outer shell.

Needle safety solution wins coveted packaging prize

German packaging firm Gerresheimer has been awarded another prize for its innovative safety-conscious rigid needle shield, this time winning the World Packaging Organisation's renowned WorldStar award.

Abraxis BioScience splits in two

Abraxis BioScience will be separating the company into two independent public companies following accelerated growth, the US-based firm announced this week.

Combo contraceptive spray delivers the goods

Aussie drug delivery firm Acrux has reported positive results from trials of its novel transdermal spray, tested for the first time with a combination contraceptive formulation.

Australia to increase monoclonal antibody production

Australia is soon to boast the largest monoclonal antibody production facility in the Southern Hemisphere, which will go some way in alleviating the increasing demand for the biologic agents.

People on the move: pharmaceutical manufacturing

NPS Pharmaceuticals, Targanta Therapeutics, Merck & Co., MAP Pharmaceuticals and Merrimack Pharmaceuticals have all had people on the move in the world of pharmaceutical manufacturing.

Contract manufacturing news in brief

Agilent, Goodwin Biotechnology, IntegrityBio, Vastox, and AMRI have all made new contract manufacturing announcements this past week.

Serono offers 'head start' on MS drug access

EMD Serono has this week announced a plan to give faster and wider access to its multiple sclerosis (MS) drug to those suffering from the most common form of the debilitating disease.

New diarrhoea drug adds to IBD arsenal

Italian firm Cosmo Pharmaceuticals has announced positive preliminary results from trials testing out a new formulation of an antibioticfor traveller's diarrhoea that makes use of the company's innovative MMX technology.

NPS takes steps in new outsourcing plan

NPS Pharmaceuticals has sold two facilities and appointed a new COO as part of a recently revealed restructuring strategy to rely more on outsourcing.

Initiative launched to tackle ICH

The International Society for Pharmaceutical Engineering (ISPE) has launched a new initiative to help implement the International Conference on Harmonization (ICH) guidelines.

Azur snaps up FazaClo as Avanir reshuffles

Irish firm Azur Pharma is the proud new owner of schizophrenia drug FazaClo (clozapine), sold off by pharma firm Avanir as it struggles to scrape together resources to fund development of its lead candidate, Zenvia (dextromethorphan, quinidine).

NextPharma moves forward with funds and acquisition

British contract manufacturing organisation (CMO) NextPharma Technologies has announced a €30m fundraising round and the acquisition of Bioserv, another CMO based in the US.

Nanotube longboats help in the sacking of tumours

US researchers have developed a method of using carbon nanotubes to carry platinum anticancer pro-drugs into cancer cells so that they can unleash their deadly cargo with greater effect.

BioAlliance's buccal tab brings in the cash

A novel antifungal treatment developed by French firm BioAlliance has attracted a US partner, bringing $65m (€48m) to the company only months after announcing a multi-million deal in Europe.

Sartorius Stedim Biotech born

The hook-up between German and French firms Sartorius and Stedim to create a combined biotech business is now complete, with the deal finalised and the new company ready to roll.

EU approves recombinant fertility drug duo

A new recombinant combo treatment that could help some of the rising number of women experiencing fertility problems, has now been approved for use in the Europe.

South Korea acts to save its pharma industry from US competition

South Korea is to inject about one trillion won ($1.07bn) into its pharmaceutical industry to give it a rev up as the newly signed free trade agreement (FTA) with the US comes into force.

Systech upgrades packaging software

US-based Systech International has enhanced its features to its packaging software application, Systech Guardian.

Invitrogen launches 3D cell scaffold

Invitrogen has launched an animal-free, 3D bioscaffold cell culture system, to allow researchers to study cells in an environment that mimics the conditions of cells in the body.

Prolonged-release schizophrenia drug gets EU approval

A new and improved extended-release treatment for schizophrenia has been granted marketing authorisation by the European Commission. Invega (paliperidone) is a once-daily formulation that will be marketed by J&J subsidiary, Janssen-Cilag.

Massive vaccine deal makes Intercell's day

One of the most significant deals to take place in the vaccine industry in the last ten years was signed late last night between vaccine heavyweight Novartis and biotech firm Intercell.

Final stages of Bradman Lake's new packaging machinery facility

The finishing touches are being added to the new Bradman Lake Group's packaging machinery facility in Norwich, Norfolk, as the company continues on its global expansion plan.

Anti-obesity drug slim on safety aspects

Sanofi-Aventis' hotly touted anti-obesity blockbuster drug has become weighted down in safety concerns as the French company withdraws its New Drug Application (NDA) in the US and awaits a safety review in the EU.

AstraZeneca makes latest outsourcing move in France

AstraZeneca has sold a manufacturing plant in France to a contract manufacturer who will continue to supply the drug giant with its products under a new outsourcing contract.