All news articles for June 2007

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28-Jun-2007

'Cryogel' bioreactor pumps out antibodies continuously

Researchers have developed a new 'supermacroporous cryogel' bioreactor for the long term continuous production of monoclonal antibodies (mAbs) that outperforms T-flask batch cultivators.

Paperless manufacturing for Genzyme

Genzyme has opted to deploy Werum's PAS-X management executions system (MES) software in its Waterford, Ireland, plant.

Pharma investment in Ireland 'unbelievably significant'

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).

Reformulated Rebif right on track

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).

Bespak to cut jobs as Exubera prospect falls short

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.

Approval for inhalable fentanyl looking painless

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.

Aspartame safety called into question

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.

Regulation and manufacturing come together

A US software solutions provider has signed up Merck & Co for the global installation of a system which will bring together regulations and manufacturing.

27-Jun-2007

Soliris gets approval in Europe

Orphan drug Soliris (eculizumab) has been approved by the European Commission and marks the first therapy for a rare and life-threatening blood disease.

SkyePharma's controlled release doze gets the nod from Somnus

SkyePharma's novel controlled-release sleep therapeutic has been licensed by Somnus Therapeutics in an exclusive worldwide development and commercialisation deal.

Procter & Gamble looking to outsource API work

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.

Skin graft technology hailed as 'breakthrough'

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.

Oral Tysabri steps up to the plate

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.

People on the move: pharmaceutical manufacturing

PTC Therapeutics, Encysive, Novagali Pharma and Insmed have all had people on the move in the world of pharmaceutical manufacturing.

Needle-free system injecting change

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.

Plant-based insulin to jump to Phase II next year

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.

26-Jun-2007

Three new 'biosimilars' to be launched in EU

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.

Contract manufacturing news in brief

Granules India, Dalton Pharma Services, Polymun, and CMC Biopharmaceuticals have all announced new contract manufacturing deals this week.

New manufacturing operations solution

A new software system to streamline manufacturing operations has hit the market and promises to be the pharmaceutical industry's new best friend.

Integrating the monitoring of bioprocesses

Dutch researchers have developed a sensor array for monitoring fermentation in microwell plates to aid bioprocess design and scale-up.

Once daily Cialis comes up with the goods

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.

Updated FDA follow-on biologics bill released amidst anticipation and trepidation

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.

Alexion's drug first to get EU fast-track approval

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.

Bioxel submits DMF for docetaxel

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.

25-Jun-2007

Microtest, Texcel combine for 'combo drugs'

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.

Another solution for long-lasting proteins

Another company has jumped on the band wagon to find an innovative way to increase the half-life of therapeutic proteins.

Viracept saga continues

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.

Viragen drops transgenics project

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.

Novo Nordisk expands another facility

Danish drug-maker Novo Nordisk is continuing in its drive to expand its manufacturing facilities around the world; the latest being in the US.

Genzyme pens deal for Parkinson's gene therapy

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.

21-Jun-2007

Ex Cardinal Health contract biz reborn as Catalent

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.

Greenovation receives first US patent for moss technology

German biotech company, Greenovation has received a broad ranging US patent for its unique moss-based biopharmaceutical production technology.

Novartis' combo hypertension drug approved in US

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.

Disposables crucial in future of patient-specific meds

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.

ISPE releases revamped API guide

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 snaps up new ADHD patch

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.

20-Jun-2007

EU and US agencies bolster bonds

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.

Russians left in the dark despite lifted export ban

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.

New flu vaccine super-adjuvant enters Phase I

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.

Patheon and Senopsys in tasty deal

Patheon is teaming up with formulation development services firm Senopsys to offer pharma companies combined services to test and improve drug flavour.

People on the move: pharmaceutical manufacturing

Plexxikon, Oculus, MedImmune and Pharmatech Associates have all had people on the move in the world of pharmaceutical manufacturing.

CuraGen manufacturing plant to close

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.

Innovative drug delivery system a breath of fresh air

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.

Technology for long-acting proteins here to stay

Modigene has made inroads into its development of long-acting proteins through the use of its Carboxyl Terminal Peptide (CTP) technology.

19-Jun-2007

Asia beckons DSM anti-infectives

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.

CORVUS throws blood brain barrier a curve ball

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.

Genmab-GSK drug has arthritis potential

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.

Merck-Serono pushes next generation hGH product

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.

Aptuit splurges $100m in India

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.

The sound of separation?

Swedish researchers have developed a method of separating a continuous flow of (bio)particles based on their size and density using acoustic forces.

Cosmo gets to the bottom of IBD

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.

Two pharma latest to catch pandemic preparedness bug

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.

14-Jun-2007

Respirics to sell-off MD Turbo technology

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.

Manufacturers back WHO avian flu stockpiling plans

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.

West wields the axe in UK

The loss of a significant contract has left West Pharmaceutical Services wielding the axe at one of its UK facilities.

Viracept: lessons to be learnt?

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.

KV boosts drug delivery abilities

KV Pharmaceutical has snapped up a specialist coatings firm that it hopes will enhance the company's drug delivery product pipeline.

Manufacturers to get insider tips from big guns

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.

To test or not to test? The glycerin debate

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.

13-Jun-2007

Early birds preserve market share

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.

ImClone intimidated key witness, court rules

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.

Solvay ups soda ash production

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.

Cell-based flu jab gets EU go ahead

Swiss drug maker Novartis today announced that it has gained EU approval for it new cell-based flu vaccine, Optaflu.

Melting DNA in microfluidic devices

German researchers have developed a microfluidic device that greatly increases the efficiency of measuring the melting temperature of DNA double strands.

Lonza leans towards highly potent APIs

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).

People on the move: pharmaceutical manufacturing

VaxInnate, Inspire Pharmaceuticals, Par Pharmaceutical and Progen Pharmaceuticals have all had people on the move in the world of pharmaceutical manufacturing.

Injectable asthma formulation uses Captisol technology

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.

12-Jun-2007

Prosolv tech in API development pact

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

Applikon releases 'generic' bioreactor controller

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.

Pharma industry 'better off' under new REACH rules

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.

New plant pushes Novo's biopharma plans forward

Novo Nordisk has inaugurated its new pilot plant for biopharmaceutical products in Denmark in its latest move to expand its presence in biopharmaceuticals.

Patheon steps up 'damage control' over Puerto Rico

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.

Kurve Technology and Schering-Plough expand agreement

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 to use new plasma protein extraction technology

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.

11-Jun-2007

Genzyme anticipates demand for thymoglobulin with new plant

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.

Histological studies validate Rexin-G as targeted gene therapy for cancer

Histological evidence of tumour destruction has confirmed the promise of Epeius Biotechnologies' Rexin-G as an effective targeted gene therapy platform for metastatic cancer.

New triptorelin formulation Phase III cancelled

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.

Rexam swoops to O-I rescue

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).

GE boosts biotech production

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.

FDA probe continues to hit MDS Pharma's pocket

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.

Cancer biotherapy market set to boom

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.

07-Jun-2007

Intertek in US analytical lab buyout

UK's Intertek Pharmaceutical Services is expanding the range of its offerings with the acquisition of QTI, a US contract analytical laboratory.

The 'biogeneric' analysis problem

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.

Malta gives Siegfried the generic advantage

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.

Anticancer nanodelivery vehicles

Researchers from UCLA in the US, have created a new nanoparticle delivery system to allow water-insoluble drugs to be released into cancer cells.

Contamination leads to EU-wide Viracept recall

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.

Active Biotech drug could have the edge in oral MS race

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.

Is Amgen turning into a big pharma?

Biotech titan Amgen announced yesterday the acquisition of a small molecule developer - the second buyout of this type in less than a week.

Recombinant Protein A supply for 4 years

Applied Biosystems has entered into a four-year supply agreement with Repligen to receive recombinant Protein A.

Intranasal NSAID a first for pain relief

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".

06-Jun-2007

Biomanufacturing news in brief

Morphotek, CMC Biopharmaceuticals, Cobra Biomanufacturing, and Fraunhofer have all announced new contract manufacturing deals this week.

Roche's RA drug one step closer to the market

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.

Contract manufacturing news in brief

Morphotek, CMC Biopharmaceuticals, Cobra Biomanufacturing, and Fraunhofer have all announced new contract manufacturing deals this week, while Jubilant Organosys completed its US buyout.

Extended storage for Teva MS drug

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.

People on the move: Pharmaceutical manufacturing

Bionovo, Somaxon Pharmaceuticals, Trius Therapeutics, Exelixis, AmerisourceBergen Corporation and Kindred Healthcare have all had people on the move in the world of pharmaceutical manufacturing.

'Living fossil' stops HIV in its tracks

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.

Sartorius puts PER C6 on the disposable map

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.

Million Euro milestone for GSK drug

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.

Abbott to use Dowpharma technology

Abbott is the latest pharmaceutical company to scoop up Dowpharma's exclusive protein-producing technology.

Valeant sheds final facilties

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.

05-Jun-2007

Specialist label maker opts for Datalase technique

Schreiner MediPharm, a leading manufacturer of 'intelligent' labels has chosen Datalase's flagship Packmark printing technique for its customers in the pharma industry.

UK to pioneer carbon footprint labelling innovation

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.

deltaDOT lets fly with new drug discovery tool

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.

Ipsen boosts manufacturing in France

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.

AstraZeneca picks up abandoned DSM facility

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.

Top legal tips for the perfect M&A deal

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.

SPI Pharma responds to Roquette's patent claim

SPI Pharma has denied infringing Roquette Freres mannitol excipient patent and has claimed instead that Roquette's patent is invalid.

Amgen bolsters portfolio in kidney disease via $420m buy

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.

Potential breakthrough for potential outbreaks

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.

Flu vaccine guidance finalized

Guidelines for the safe and effective supply of seasonal and pandemic influenza vaccines have been finalized by the US Food and Drug Administration (FDA).

Danish biopharma to supply 20 million smallpox vaccines to US

Denmark-based Bavarian Nordic has clocked up a whopping $500m (€371m) contract with the US government to supply millions of doses of smallpox vaccine.