All news articles for April 2007

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30-Apr-2007

Boehringer steps up contract manufacturing in Mexico

Boehringer Ingelheim is stepping up its commercial contract manufacturing operation in Mexico to feed the ravenous North American market.

Germany next on AstraZeneca's hit list

Pharma giant AstraZeneca has announced the latest site to fall victim to its restructuring plans announced in February, with the company dropping one of its German plants and axing hundreds more jobs.

Cell-made flu vaccine gets green light from EU panel

Swiss drug major Novartis moved has closer to approval for an influenza vaccine that would do away with the use of cumbersome egg-based production techniques and speed up the supply of seasonal flu vaccine stocks.

PharmaFab agrees to stop unapproved drugs production

US contract manufacturer PharmaFab has agreed to stop the manufacturing and distribution of some of its drugs after regulators found they were produced illegally.

Carbenes offer new route to amino compounds

Chemists have found a way of activating ammonia that could have important implications for pharmaceutical research and development.

26-Apr-2007

Roche updates on flu manufacturing; expands US unit

Roche gave an update on its manufacturing of influenza drug Tamiflu (oseltamivir) today, saying that while it had reached its target capacity of 400 million doses a year, demand is running much lower.

e-Nose how to sniff the good from the bad

Alpha M.O.S. has recently released an update for its Fox electronic nose (e-Nose) to provide faster analytical analysis of samples in R&D, quality control (QC) and process monitoring settings.

US biotech drug spending rises while Congress debates 'biogenerics' law

Biologic drugs are expected to account for over a quarter of overall drug spending in the US by 2010, new research has revealed, and clearing the path for generic versions of these drugs could be a solution to controlling rising national healthcare costs.

OctoPlus broadens rights to PolyActive delivery technology

Dutch company OctoPlus has extended its rights to the PolyActive delivery technology used in its lead drug candidate Locteron, based on interferon alfa.

WHO to help fund bird flu vaccine plants in developing world

The World Health Organization is donating millions of dollars to help developing countries set up their own influenza vaccine production in preparation for a possible bird flu pandemic.

Paladin Labs buys into film technology with BioEnvelop deal

Paladin Labs has reached an agreement in principle to acquire the outstanding shares of BioEnvelop Inc, which develops, manufactures and markets rapidly dissolving edible films for use as delivery systems in the pharmaceutical and nutraceutical sectors.

Owens-Illinois seals healthcare plastics joint venture in Mexico

Owens-Illinois, the US company best known as a manufacturer of glass containers, has finalised a 50/50 joint venture with Pavisa Industries to manufacture and sell plastic healthcare containers in Mexico and other Latin markets.

25-Apr-2007

Gene repair technology provokes biotech formation

A new biotech company has been formed to fully exploit technology for repairing genes that cause rare, hereditary diseases such as sickle cell anaemia and spinal muscular atrophy.

Corn-based plastic heading for pharma packaging use?

A crop-based alternative to regular plastics that is biodegradeable and compostable, developed by biotechnology firm Metabolix and agriculture giant Archer Daniels Midland, is to be developed for pharmaceutical applications.

New deals for ProBioGen's cell engineering group

ProBioGen, a specialist in mammalian cell engineering and cell culture, has entered into two separate agreements to develop therapeutic proteins with Egyptian drug manufacturer Minapharm..

Roquette wins US patent for StarLac in novel dosage form

French company Roquette has been awarded a US patent for a dissolve-in-the-mouth drug delivery technology that makes use of its novel StarLac excipient.

India's Jubilant buys US-based CMO

Indian contract research and manufacturing services (CRAMS) firm Jubilant Organosys has announced the purchase of US-based company Hollister-Stier Laboratories for $122.5m (€90m) in what represents one of the largest overseas acquisitions by an Indian company in the CRAMS sector.

BioQuate stands firm on patent infringement suit

BioQuate has denied claims that its mainstay device for improving media throughput and maintaining sterile system integrity in biotechnology production, infringes on a patent for a rival product marketed by filtration and separation specialist Pall.

Oral patch data means smiles all around at BDSI

A novel buccal patch formulation of the opioid painkiller fentanyl is on track to be filed for approval in the third quarter of this year, following encouraging efficacy data from a Phase III trial.

24-Apr-2007

GSK may tap Futura for topical pain relief product

UK firm Futura Medical is in the running for a second license contract for one of its drug delivery platforms after pharma heavyweight GlaxoSmithKline came to the table to discuss terms.

New Novozymes unit backs animal-free protein production

Denmark's Novozymes has set up a dedicated business unit in the UK to make and sell ingredients that support companies wanting to produce biopharmaceuticals without using animal-derived constituents.

Cold-form film, security foil boost Constantia in pharma

Successful applications of cold-form film and security foil helped the Pharma/Healthcare division of Austria's Constantia Packaging to deliver above-average growth in 2006, the company reported.

Freeman Technology wins Queen's Award

Freeman Technology has been awarded the Queen's Award for Enterprise 2007 for Innovation and recognises the development, commercialisation and sales success of its FT4 Powder Rheometer.

Amgen posts strong results after Aranesp relief

Biotech giant Amgen has posted healthy results for the first quarter following a positive performance by its blockbuster anaemia drug Aranesp (darbepoetin alfa).

Senate bill aims to give FDA more power

A bill aimed at tightening up the Food and Drug Administration's oversight of prescription drug safety moved one small step closer to the statute books late last week after it passed the Senate Health, Education, Labor and Pensions (HELP) Committee by a 15 to five vote.

E. coli offers short-cut to large-scale antibody production

A new method for generating large volumes of therapeutic antibodies direct from Escherichia coli bacterium could knock weeks off conventional mass-production processes that scale up to mammalian cells, US researchers believe.

Varian launches dissolution system for drug-device combinations

Varian has launched a new dissolution system specifically geared to testing small drug volumes in medical devices such as implants or drug-eluting stents.

23-Apr-2007

Pharmaceutical industry biding its time on RFID adoption

While technology cost and lack of a demonstrated return on investment constitute the biggest barrier to adoption of radio frequency identification (RFID) in the pharmaceutical industry, the lack of a frequency standard runs these factors a close second, a new report has found.

DelSite smells success for novel flu vaccine

A nasal powder flu vaccine is one step closer as DelSite Biotechnologies announces that it has found an antigen to use with its novel drug delivery system.

Winners of Life Science Industry Awards revealed

The winners of this year's Life Science Industry Awards have been announced, after scientists from across the world voted for the "best-in-class" companies in the sector.

BioProgress nudges into profit with new market-driven profile

A new market-oriented approach to product development, more favourable licensing arrangements, strategic acquisitions and a fresh crop of proprietary drug-delivery technologies helped UK company BioProgress to deliver an adjusted operating profit for the first time in its history in the year to 31 December 2006.

Promed's Indian injectables plant opens

Indian contract manufacturer Promed has finally opened its newly-built parenteral manufacturing plant in Himachal Pradeshon, India.

19-Apr-2007

Pharmaceutical manufacturing: People on the move

Biovitrum, China Biopharma, Molecular Insight Pharmaceuticals, Pipex Pharma and CH2M Hill have all had people on the move in the world of pharmaceutical manufacturing.

There's something fishy in the water

A new method to identify the extent of contamination of our waterways by pharmaceutical products has identified three products previously unknown to accumulate in fish.

Gelatine-based vectors offer smoother passage for gene therapy

Gelatine-based nanoparticles may offer a new delivery route for gene therapy that skirts the complications of viral-based vectors.

Multisorb absorbs UK active packaging firm

US firm Multisorb Technologies yesterday announced that it has bought up Silgel Packaging, a fellow manufacturer of desiccant packaging products.

Cell Genesys immunotherapy is patient specific

Positive results from trials of Cell Genesys's latest immunotherapy treatment, GVAX, show that the therapy induces a broad immune response in prostate cancer sufferers that is patient specific.

Lonza splashes out on biomanufacturing expansion

Swiss contract manufacturer Lonza has announced it will invest around $300m (€220m) in the expansion of its US biomanufacturing plant, just two weeks after kicking off the construction of a similar facility in Singapore.

Genta gives Genasense another chance

Genta is giving its lead anticancer product Genasense another chance by announcing its plans to conduct a new late-stage clinical trial of the drug, despite having previously been turned down by the US regulators.

Millipore launches disposable mixing tech

A new single-use mixing system for pharmaceutical ingredients has been announced by biopharma manufacturing specialists Millipore.

Northwestern researchers find route to single-isomer flavonoids

A research team at Northwestern University in Illinois, US, has found a new way of synthesising chiral forms of flavonoids that could make them easier to manufacture and enhance their potential as therapeutic compounds against cancer and other diseases.

ATMI LifeSciences takes joint-venture route into Asia-Pacific

ATMI LifeSciences, a Belgian company that manufactures and supplies film-based single-use packaging products for the biopharmaceutical industry, has set up a joint venture, ATMI Austar LifeSciences, Ltd, in the Shanghai area of China.

18-Apr-2007

New technologies, needs will spur transdermal/transmucosal delivery

A combination of new drugs, new patient needs and new technologies is likely to fuel steady growth in the transdermal/transmucosal drug delivery market during the years to 2010.

Patheon drops OTC biz in major restructure

Canadian contract manufacturer Patheon has announced its plans to restructure its Ontario network of drug manufacturing facilities in order to improve its profitability.

Sanofi ups production capacity after vaccine go-ahead

Reports of a €200m expansion at Sanofi Pasteur's production plant in Rouen, France, have come hot on the heels of news that the US Food and Drug Administration (FDA) has approved the company's vaccine to protect humans against bird flu.

Dose-by-dose does it for 3M

A new integrated dose counter is being launched this week by 3M's drug delivery systems business, providing a new solution to recent regulatory requirements for metered dose inhalers.

FDA gives Sanofi thumbs up for first bird flu vaccine

Sanofi-Aventis' H5N1 bird flu vaccine has won approval from the US Food and Drug Administration (FDA) as a limited protection measure in case of a pandemic.

LibraGen's new active molecules hit the market

French bioprocess specialist LibraGen has released its first family of active molecules produced using the firm's biocatalysis technology onto the market.

Excipient aims to improve cancer treatment

Pro-Pharmaceuticals is preparing to submit a New Drug Application (NDA) for its lead product candidate, Davanat, as a functional excipient that promises to hike the efficacy and cut the side effects of cancer drugs.

SCOLR pushes ahead with 12-hour ibuprofen

Drug delivery specialist SCOLR Pharma plans to file a US New Drug Application (NDA) in the latter half of 2008 for a 12-hour tablet formulation of the painkiller ibuprofen.

First customer for USP's ingredient verification service

The Pharmaceutical Ingredient Verification Program offered by the United States Pharmacopeia (USP) has scored its first taker, with Indian firm Dr Reddy's Laboratories yesterday announcing that it had signed up to the scheme.

17-Apr-2007

Avant cuts 30 per cent staff in 'painful' restructuring

Avant Immunotherapeutics will reduce its workforce by a third as part of a "painful" restructuring aimed at cutting operational costs, the US-based firm announced this week.

Leading pharmaceutical news franchise expands into US

Decision News Media leads the field in Europe for online pharmaceutical technology news with its In-PharmaTechnologist.com, and now plans to repeat the trick on the other side of the Atlantic.

IPS makes a move to India

Integrated Project Services (IPS) has announced it has opened two offices in India in a bid to expand its services into this budding region.

GE pockets single-use biotech firm

GE Healthcare has snapped up specialist in disposable manufacturing technologies Wave Biotech, adding a host of new products and services for the biopharmaceutical manufacturing sector to its catalogue.

deltaDOT's Peregrine preys on mass spec applications

UK company, deltaDOT is awaiting the completion of its second production run of its novel high-resolution molecular analyser - the Peregrine - with over half the batch already sold.

Bobst moves Braille embossing down the production line

Switzerland's Bobst has introduced a new system for embossing Braille characters on pharmaceutical packaging that moves the process down the production line from die-cutting to the folding and gluing stage.

Millipore brings RFID to pharma filtration

Millipore is launching the first in a line of filtration products for the biopharmaceutical industry with embedded Radio Frequency Identification (RFID) technology to facilitate record-keeping and data transfer in the manufacturing environment.

Chromos restructures as bankruptcy looms

The fortunes of Canadian company Chromos Molecular Systems have taken an abrupt turn for the worse after the successive collapse of a co-development deal for the company's experimental monoclonal antibody, CHR-1103, and an aborted private placement that would have provided much-needed funds of C$4m (€2.6 million).

Viropro inks production tech deal

Canadian firm Viropro last week announced that it has entered into an R&D collaboration agreement with products and services company Invitrogen.

16-Apr-2007

Polymeric pain relief product to hit the shelves

US firm Skinvisible last week announced that its polymer-based delivery system has been licensed to pain relief company DRJ for use in a new topical analgesic product.

'Germinating' sperm from stem cells

A new study has shown that certain human bone marrow stem cells can differentiate into sperm stem cells - potentially leading to a revolution in fertility therapy.

Exubera has opened door for pulmonary delivery growth

While the market performance of Exubera may have fallen short of expectations, Pfizer's inhaled insulin has opened the door for a wider variety of macromolecules to take the pulmonary delivery route.

IMA buys out rival

The IMA Group announced late last week that it has successfully bought one of its leading competitors in a deal worth €1.4m.

Contract manufacturing news in brief

Hyaluron, MultiCell Technologies and Affitech have all announced new contract manufacturing deals this week.

Skye formulation accepted for GSK drug

UK firm SkyePharma last week announced that the US Food and Drug Administration (FDA) has accepted a filing for the extended release formulation of partner GlaxoSmithKline's (GSK) drug Requip (ropinirole).

13-Apr-2007

Genentech financially strong while Amgen struggles

Genentech, the world's second biggest biotech company, has shown a strong performance in the first quarter while its main rival Amgen is trying to regain momentum after a difficult year.

EuropaBio urges EU members to unite in biotech strategy

The European Union's (EU) member states must take their responsibilities to implement the biotech policy proposed by the European Commission (EC), said EuropaBio, the EU industry body.

MedImmune 'for sale'

Biotech company MedImmune has finally given in to recent pressure from its shareholders and announced yesterday it is putting itself up for sale.

12-Apr-2007

Vical's super-boosting vaccine adjuvant

US firm Vical has announced study results revealing a flu vaccine reinforced with the firm's Vaxfectin adjuvant results in an antibody response 60 times higher than the vaccine alone, and allowed a 10-fold reduction in vaccine dose.

Millipore adds small-volume sampler to NovaSeptum range

Millipore has added a small-volume unit to the NovaSeptum range of sterile disposable sampling systems it acquired with Swedish company NovAseptic in July 2005.

'Perfect time' for big pharma/biotech alliance deals

Now is an ideal time for small biotechs to ink that perfect deal with big pharma, attendees heard at the recently held Biotrinity conference in Oxfordshire, UK.

Harnessing the therapeutic power of venom

A new peptide library could make it easier for drug developers to fully exploit the known therapeutic effects of venoms.

ImClone slides as pancreatic cancer trial misses mark

Shares in US biotech ImClone Systems fell on Tuesday after a highly-anticipated trial of its cancer drug Erbitux (cetuximab) in pancreatic cancer failed to live up to expectations.

Gilead shifts Irish ops

Major biopharma Gilead Sciences has announced plans to invest in a new €60m plant in west Dublin, Ireland, to expand manufacturing capacity and meet future growth targets.

United Drug enters mainland Europe with packaging buy

United Drug has acquired a contract packaging business from Budelpack International, making good on an earlier promise to seize opportunities to expand its outsourcing businesses.

Amgen CFO walks away

Amgen is seeing its chief financial officer (CFO) walk away while the Californian biotech giant tries to heal its wounds after a difficult year.

Charles River's mini-lab 'out of this world'

Charles River Laboratories' portable endotoxin testing system, the Endosafe PTS, has been successfully used to detect bacteria on the International Space Station (ISS).

Curious case of Combivir tampering in California

The problem of drug tampering and counterfeiting came to the fore again yesterday after it emerged that bottles of GlaxoSmithKline's widely-used HIV drug Combivir (lamivudine and zidovudine) actually contained another HIV drug sold by the drugmaker.

11-Apr-2007

Pharmatek opens new plant; Pace buys P3

Pharmatek has moved to a new larger lab and manufacturing facility while Pace Analytical Life Sciences recently acquired lab testing firm P3 Scientific.

DOR's oral leuprolide to start trials mid-year

US company DOR BioPharma plans to start clinical trials in the next few months with what could be the first oral formulation of the widely used prostate cancer treatment leuprolide.

Caterpillar cells to churn out flu vaccine

An experimental flu vaccine produced in insect cells could be a potential money-saver for pharma firms, and has proved just as effective as vaccines produced using conventional egg-based techniques.

Abbott's new biotech plant on the 'Bio Island' good to go

US pharma Abbott has announced the opening of its new state-of the-art biologics manufacturing plant in Puerto Rico.

Pharmaceutical manufacturing: People on the move

Xcellerex, Intranasal Therapeutics, Emisphere, Catalyst Pharmaceutical and Amgen have all had people on the move in the world of pharmaceutical manufacturing.

US pharma sector suffers shoddy rep

A report out this week has revealed the languishing reputation of the pharmaceutical industry among Americans, with only 35 per cent of people claiming to have a 'favourable' opinion of the sector.

DHS clarifies rules on plant security

New federal security regulations for high-risk chemical facilities in the US will not automatically take precedence over tougher provisions on chemical security already introduced by some states.

10-Apr-2007

New machine targets clinical trials market

A British packaging machinery firm has launched a new machine for labs packing quality samples for clinical trials.

US equity market potential goldmine for biotech companies

The US equity market is open to biotech companies and it is a good time for them to raise money, delegates heard at Biotrinity in Oxfordshire, UK.

BIA backs up pro-hybrid embryos report

The BioIndustry Association (BIA) said it fully supports a UK Parliamentary Committee report which endorses the creation of animal-human embryonic hybrids in drug research.

Multi-talented RFID tag hits pharma market

The first radio frequency identification (RFID) tag that authenticates, encrypts data and monitors product temperature hit the shelves last week, aimed specifically at protecting the pharmaceutical supply chain.

Mar Cor buys dialysis water business from GE

Mar Cor Purification has bought GE Water and Process Technologies' dialysis water business for $30.6m (€22.8m) to become the largest provider of dialysis water in the US, and plans to expand their presence in industrial life science markets.

Merck & Co signs up for Codexis biocatalyst panels

Codexis netted another big pharma client for its biocatalytic process technologies as Merck & Co became the first subscriber to Codex Biocatalyst Panels, a new research product that gauges the potential for speeding up production of active pharmaceutical ingredients and intermediates through customised biocatalysts.

05-Apr-2007

Germany's IWKA sheds its packaging division

IWKA, a German automation specialist that designs and builds manufacturing and packaging systems, is selling its packaging division to Berlin-based investment company Odewald & Compagnie for around €255 million.

Microneedle tech to boost intradermal drug delivery

Drug delivery technology firm Apogee has signed an exclusive licence to get its hands on a microneedle-based drug delivery technology that it hopes will significantly enhance the company's PyraDerm intradermal drug delivery system.

On-line glucose measuring with Finesse

The first step towards true in-line glucose monitoring for cell culture bioprocesses has been made that will allow greater control over the bioprocess manufacturing.

Spanish group finds recyclable medium for thioether derivatives

A group of researchers at the University of the Basque Country in Spain has developed a method of synthesising thioether derivatives using a cheap, non-toxic and recyclable medium that could have significant cost and efficiency implications for the manufacture of some pharmaceuticals.

Are you prepared for Mother Nature?

Many sites are utterly unprepared in the face of a natural disaster and are paying a heavy price if they are unlucky enough to be affected, delegates heard at last week's Drug Information Association (DIA) conference in Vienna.

Akorn warned over GMP failings at Decatur plant

Akorn, a US pharmaceutical company that develops, manufactures and markets branded and generic diagnostics and therapeutics for niche segments such as ophthalmology, rheumatology and anaesthesia, has received a warning letter from the Food and Drug Administration about significant deviations from current Good Manufacturing Practice (cGMP) regulations at its Decatur, Illinois facility.

FDA drug and biologic inspections reach five-year low

As the US Food and Drug Administration (FDA) came under heavy fire for cuts in inspections at a time when safety alerts are mounting up, agency statistics showed that inspections by the Center for Drug Evaluation and Research (CDER) reached their lowest level in fiscal 2006 since FY2002.

New software to aid FDA compliance

US firm Fullscope has announced the availability of a new software and services package to help pharmaceutical and life science companies achieve and maintain US Food and Drug Administration (FDA) validation.

04-Apr-2007

Vetter wins award for best facility processes

German contract manufacturer Vetter Pharma-Fertigung has been bestowed with a "facility of the year award" for the processes employed at its new injectables plant.

Pfizer spies pSivida's injectable eye treatment

Pfizer has homed in pSivida's controlled release drug delivery technology, signing a research and licensing deal worth $165m (€123.5m) and focusing keenly on the company's Medidur technology for new ophthalmic applications.

Pharmaceutical manufacturing: People on the move

DSM, Ipsen, Somaxon and MonoSolRx have all had people on the move in the world of pharmaceutical manufacturing.

Amgen puts the brakes on Irish plant plans

US biotech Amgen has announced plans to delay construction of its major new manufacturing plant in Cork, Ireland.

Ajinomoto launches stable dipeptide

US-based Ajinomoto Aminoscience has launched AminoStable, an L-Alanyl-L-Glutamine dipeptide for use in pharmaceutical products and cell culture media.

Advancis tries again with once-daily, lower-dose amoxicillin

Advancis Pharmaceutical Corporation, a US company focused on developing and marketing novel anti-infectives, has refiled a US New Drug Application (NDA) for Amoxicillin Pulsys, its once-daily, pulsatile-release antibiotic for the treatment of tonsillitis and/or pharyngitis in adults and adolescents.

Becton Dickinson broaches US safety pen market

Becton Dickinson (BD) has extended its existing franchise in safety injection products and insulin delivery technologies into the safety pen needle market, with the US launch of the BD AutoShield Pen Needle.

AAIPharma completes $2m boost to manufacturing capacity

AAIPharma yesterday announced that it has completed a major round of upgrades to two of its manufacturing plants in the US.

03-Apr-2007

Contract manufacturing news in brief

Diosynth and Pharmatek have both announced new contract manufacturing deals while WuXi PharmaTech installs a new "green" enantiomer technology.

Pack-size limits pointless in paracetamol poisoning

A report this week suggests that enforced restrictions in pack size for paracetamol (acetaminophen) in the UK may have had little or no impact on reducing the number of paracetamol poisonings.

Alphacos offers new guard against needle-stick injuries

Swiss packaging-machine manufacturer Alphacos has launched a new product to help protect healthcare workers using pre-filled syringes against needlestick injuries.

Patient info leaflets found lacking

A study into the effectiveness of written information supplied with drugs in patient information leaflets (PILs) has found the inserts wanting, with complicated language, bad design and a lack of appreciation for the end-user's concerns.

Adams taps into MonoSol's fast-dissolve technology

A thin-film delivery system that looks like a postage stamp and dissolves rapidly on the tongue could give new momentum to Adams Respiratory Therapeutics' portfolio of prescription and over-the-counter medicines (OTC) for the treatment of respiratory disorders.

PharmEng consolidates acetaminophen supply with China's Bayi

Canadian-based consulting and contract manufacturing company PharmEng International has built on an existing sourcing arrangement with Bengbu Bayi Pharmaceuticals to secure exclusive distribution rights to the Chinese company's bulk acetaminophen in North, Central and South America.

02-Apr-2007

Contract formulators called on to ease bottlenecks

Contract formulation firms are being increasingly relied upon to ease drug development bottlenecks being created by new drug discovery technologies.

GE and BAC extend purification pact

GE Healthcare and the Bio Affinity Company (BAC) have extended their biopharmaceutical partnership to develop purification media for Factor VIII (FVIII) for the treatment of haemophilia A.

Have your say: New excipient GMP regs

Excipient manufacturers and users are being encouraged to take part in an online consultation set up by the European Commission to assess the impact of kicking off formal good manufacturing practice (GMP) regulations for excipient production.

Singapore growing biopharma strength

As Swiss firm Lonza announced last week that it has broken ground at its second manufacturing site in Singapore, the region looks set for growth in biologics manufacture with biological products due to take centre stage in the pharma industry over the coming years.