Breaking News on Pharmaceutical Technology

Extreme pipetting

Artel is sending three of their employees to the most extreme environments in the US to demonstrate the impact of environmental conditions on pipetted volumes.

Cobra: 'process development is the key'

Process development is the key when outsourcing clinical supply biomanufacturing to a contractor, according to an industry player.

Gerresheimer expands pharma glass ops

German packaging firm Gerresheimer has bought up the glass manufacturing operations of an American packaging company in its second significant acquisition in three months.

EMEA 'passing the buck' with clinical trial guideline

The European Medicines Agency (EMEA) makes sensible recommendations in its recently released 'first-in-man' clinical trials guideline but is somewhat passing the buck, according to a statistician with expertise in clinical trials.

Sunny Skyes as injectables business falls to earth

UK firm SkyePharma has announced that it has finally completed the sale of its deadweight injectable business, freeing up the company to focus on the development of products that the company believes could rival those of the pharma big guns.

Turning over a new leaf with cellulose drug delivery

A new cellulose-based drug delivery system could be on the horizon, according to a research team presenting their work this week in the US.

Kyowa Hakko to raise European amino acid prices

Kyowa Hakko Europe is to increase prices across its range of L-amino acids by ten per cent as of April 1, in an effort to stave off margin deterioration and ensure long-term availability of the ingredients.

FDA wants tougher conflict-of-interest test for advisers

The US Food and Drug Administration (FDA) has tackled escalating concerns about the independence of its advisory committees by proposing more stringent criteria for avoiding potential conflicts of interest when considering potential committee members.

Outsourcing key to manufacture 'combo products'

Outsourcing is key for pharma companies and medical device manufacturers keen to develop and produce "combination products" - medical devices embedded with a pharma component - according to an industry player.

Rhodia to close French intermediates site

French chemicals company Rhodia has decided to shut down a local production site for its Rhodia Organics business, citing competitive pressures in the market for pharmaceutical and agrochemical intermediates.

International recruitment outsourcing set to boom

The demand for international assistance in recruitment processes from pharmaceutical companies is set to boom in the next 12 months, according to an industry player.

Novartis and Bayer bury the Betaseron hatchet

Novartis and Bayer Schering Pharma have come to an agreement regarding the production of multiple sclerosis (MS) drug Betaseron (interferon beta-1b), with Novartis planning to bring out its own version in 2009 and Bayer paying around $200m (€150.5m) for production equipment and capacity in the meantime.

Microtest aseptic manufacturing expansion brings new contract

Microtest Labs has bagged a new contract with UK-based Antisoma to make clinical quantities of the firm's new cancer drug - just a few months after expanding its manufacturing capacity.

Dow and Colorcon in controlled release collaboration

Major chemical manufacturer Dow has struck a deal with long-term partner Colorcon forming an alliance to offer a unified package for the development and production of drug ingredients and products.

DMF for ScinoPharm's docetaxel

Active pharmaceutical ingredient (API) specialist ScinoPharm has been assigned a drug master file (DMF) number for its anti-cancer ingredient docetaxel, the first such designation for the API in the US.

Contract manufacturing news in brief

Eden Biodesign, Pharmatec Laboratories, and SAFC Pharma have all announced new contract manufacturing deals this week.

Brazil to benefit from $19m biopharma deal

A Brazilian firm has signed a licensing deal to take advantage of a biopharmaceutical manufacturing technology which will allow the company to locally manufacture complex biopharmaceuticals destined for the South American market.

Scripps researchers free natural product synthesis from the protection racket

New findings from The Scripps Research Institute in the US have challenged the conventional wisdom that protecting groups are a wearying yet unavoidable rung on the ladder to natural product synthesis.

Medical House autoinjector project into next phase

UK drug delivery and orthopaedic devices company The Medical House (TMH) is entering the second phase of a development project for a European defence agency involving its AutoSafety Injector (ASI) disposable autoinjector technology for the administration of pharmaceutical products in prefilled syringes.

Chromos expects more cell engineering contracts as finances stabilise

Canada's Chromos Molecular Systems plans to step up the human resources behind its cell-line engineering business in anticipation of securing further clients within the next few months for its ACE (artificial chromosome expression) System.

AZs new PR&D centre leverages Indian chemistry expertise

AstraZeneca is leveraging the process chemistry expertise accumulated in India's generics industry and universities by opening a $15m (€11.3m) process research and development (PR&D) laboratory next to its existing research centre for tuberculosis in Bangalore.

Patent for vaccine tech to up pandemic protection

A Canadian firm's vaccine technology platform with the potential to significantly boost global flu vaccine production has been granted its first patent.

Discovery Labs' nightmare ends as lawsuit dismissed

Discovery Laboratories has announced that a shareholder lawsuit filed against the company was dismissed by a Pennsylvania court, marking the end of its two-year manufacturing nightmare.

Tec-Tor film defends against contamination

A UK company has launched what it believes is a unique safeguard against film contamination in the pharmaceutical and food industries.

Nanocrystals could be route to carrier-free drug delivery

A novel method of delivering a hydrophobic (water-insoluble) drug, in which the compound effectively acts as its own carrier, has shown comparable efficacy both in vitro and in vivo to the same drug formulated in a conventional delivery vehicle.

New smart hologram transforms to protect pharma

An innovative new platform technology with a myriad of applications has been developed by a UK firm, and promises to be a novel arrow in the quiver of the pharma industry in its attempts to shoot down drug counterfeiters.

SoloStar insulin pen to debut on ease-of-use platform

Sanofi-Aventis is gearing up for the European roll-out of a new disposable insulin pen designed to address a broader spectrum of patient needs than currently available injection devices.

Fines and imprisonment for drug fakers in the EU

The European Parliament has backed proposed legislation to impose hefty fines and penalties on criminals taking part in piracy and counterfeiting activities.

New wheat variety aids fight against blight

Researchers have created a new strain of wheat with an inbuilt resistance to devastating scab blight which infects wheat heads - reducing crop yields as well as market value and quality.

UK start-up enters contract manufacturing arena

A small UK company has entered the contract manufacturing arena by offering services to develop and make oral dose drugs and sterile injectables from its new facilities in England.

Pharmaceutical manufacturing: people on the move

Albany Molecular Research, Ranbaxy Laboratories, IBS Pharma, PhRMA and Globalpharma have all had people on the move in the world of pharmaceutical manufacturing.

Cook Pharmica biologic facility wins award

US contract manufacturer Cook Pharmica has won an industry award for its biopharmaceutical facility.

Pall protests patent breach

Pall has filed a patent infringement case in the US, claiming another firm is manufacturing and selling a device that violates patent protection of one of Pall's sterile connector products.

Bradman Lake sheds packaging brands in restructuring

Packaging technology firm Bradman Lake is selling off recently acquired brands Albro, Dico and Gravfil only months after investing in a new multi-million pound manufacturing facility.

Europe welcomes RFID with new guidelines

After a year of consultation, the European Commission has finally proposed guidelines for the implementation of radio frequency identification (RFID) technology in the EU.

'Solid waste' gets a makeover

The US Environmental Protection Agency (EPA) has proposed loosening requirements regarding certain types of recycling activities involving hazardous solid waste materials produced in chemical and pharmaceutical manufacturing.

Millipore licenses neural stem cells

A new licensing deal will allow Millipore to supply researchers with a commercial source of neural stem cells for the first time.

In-PharmaTechnologist journalist honoured as award winner

In-PharmaTechnologist.com and Outsourcing-Pharma.com journalist Kirsty Barnes has received the honour of being announced among the place winners of the 2006 Awards for Excellence in Health Care Journalism (AHCJ).

Sanofi to shut Irish plant

In the latest of a rash of pharmaceutical plant closures, Sanofi-Aventis has announced proposals to cease operations at its Waterford, Ireland site.

Cambrex finally making a comeback

Cambrex's Q4 results show that the life sciences company is finally beginning to make a comeback after deciding to sell its Biopharma unit, blamed for much of the company's financial difficulties last year.

New biogenerics law no goldmine for CROs

A potential new law mandating the running of clinical trials before a "generic" biologic drug approval may seem like a potential goldmine for contract research organisations (CROs), however, this vision is premature.

Cobra to develop spore-based oral vaccines

UK biopharmaceutical Cobra has joined an international consortium to develop a new drug delivery technique based on live bacterial spores.

UK issues consultation on enforcing EU chemicals law

The UK has become one of the first countries in the EU to issue draft proposals on enforcing the bloc's new chemicals controls law, due to add to the regulatory cost burden faced by industry.

FDA comes down on Actavis

The New Jersey facility of Icelandic firm Actavis has been slapped with a warning letter from the Food and Drug Administration (FDA) following inspections that revealed a concerning lack of quality control measures.

US biotech firm ramps up bioprocessing capacity

Biotech company Grifols has announced the expansion of its US manufacturing capacity which will allow it to increase the production of its haemophilia therapies.

Fuji gets DMF for fast dissolving excipient

Japanese firm Fuji Chemical has been assigned a drug master file (DMF) number for its new excipient for fast-dissolving oral tablets.

MDS Pharma profit dips further into the red

MDS has reported a lower first-quarter profit for its Pharma Services unit as a result of a regulatory probe of its operations.

Whatman makes it through the year

After getting through a difficult 2006, separation technology specialist Whatman has made it through to the end of the year, reporting preliminary annual financial results and looking towards a more prosperous 2007.

Hospira's contract biz set for slump

Hospira's US injectables contract manufacturing unit reported a sales jump of 32 per cent to $43.4m (€33m), however, this stellar performance is not indicative of the strength of the unit or the performance expected to follow this year.

US Oncology kicks off E-pedigree protection

US Oncology has implemented an electronic pedigree system to protect its cancer drug distribution system, bringing it firmly in line with federal drug pedigree requirements and ensuring a more secure supply chain for the company.

Patheon on the road to recovery

Patheon has managed to reduce its first-quarter loss as the company cut jobs and took steps to resolve issues at its troubled Puerto Rico plant.

Micro-jets for painless needle-free injections

Novel needle-free injections that don't cause the pain and bruising common with existing needle-free devices have been developed by a team in California.

Mobile phones call up counterfeits

A twist on an existing security technology will use enhanced mobile phones to help establish the authenticity of pharmaceutical products in developing countries.

Shire looking to buy more US biomanufacturing space

With a new drug on the market and its Massachusetts plant at capacity, British drug maker Shire is actively looking to buy more biomanufacturing space in the US.

BMS extends large Lonza deal

Bristol-Myers Squibb (BMS) has extended its large contract manufacturing arrangement with Lonza by four years.

How to survive an FDA inspection

A new white paper is now available to offer drug manufacturers top tips on surviving a US Food and Drug Administration (FDA) inspection.

UK to pull pseudoephedrine

Drugs containing pseudoephedrine and ephedrine could soon be reclassified as prescription-only the UK, in proposals drawn up last week by the Medicines and Healthcare Products Regulatory Agency (MHRA).

Industry project aims to cut animal testing of excipients

10 major pharmaceutical companies are taking part in an international data-sharing initiative to drive down the need for animal testing.

Avantium pushes crystallisation services forward

Crystallisation specialist Avantium is doubling its research capacity as demand for this type of services is set to grow.

Oestrogen patch safer than pill

Amidst swirling concerns over the side-effects of oestrogen replacement therapy in postmenopausal women, new evidence suggests that using an oestrogen patch may be safer than taking a pill.

People on the move: pharmaceutical manufacturing

Qualicaps, Eurotherm, Acambis, Invetech have all had people on the move in the world of pharmaceutical manufacturing.

Genome study drives cancer drug development

The broadest ever survey of the human cancer genome has revealed that the number of mutated genes that can cause the disease is even greater than previously thought.

Patenting stem cells is 'ethical'

A recent article published in the journal Stem Cell has advocated the patenting of isolated stem cell lines.

AstraZeneca protects Nexium supply chain

AstraZeneca has opted for unit-level mass serialisation in a bid to protect its drug supply chain from tamperers and counterfeiting.

Stellar results H&R Wasag pharma unit

Operating profit has almost quadrupled at H&R Wasag's chemical-pharmaceutical raw materials division over 2006, hitting €82.4m for the year.

Paraytec's David snatches silver from Goliaths at Pittcon2007

A two-year-old lab equipment company has beaten off competition from more established rivals to scoop an award for its new UV detector.

World's first nanospecific safety label

A Swiss firm is offering the first process risk management and safety certification for pharma companies working with nanoparticles and technologies.

Omnicare calls Cardinal to the repackaging rescue

Omnicare has picked Cardinal Health to be its contract repackager for the drugs previously produced at its troubled Ohio facility.

Drug imports debate rumbles on

Proposed legislation to allow cheap drug imports into the US met with opposition this week as representatives from the pharmaceutical industry resisted the move saying there are 'better, safer alternatives' to imported drugs.

New child-proof blisters

Alcoa Flexible Packaging has introduced a range of new child-resistant blister-lidding packaging solutions for the pharmaceutical market.

Inhaler to deliver powerful anti-flu drugs

A new dry power inhaler has been developed to deliver potent anti-influenza drug treatments that last longer and require only a single dose.

Liposome technology to help DNAi-based cancer drug delivery

Biotech company ProNAi Therapeutics plans to use a new liposome technology to help deliver its new class of DNA interference (DNAi)-based drug.

Second generation HIV drug enters clinical trials

The second generation of a new class of HIV drugs have entered clinical trials and could prove more difficult for HIV to develop resistance to, according to developers Panacos.

In-Pharma Technologist Special Feature

Focus on: radio frequency identification (RFID) technology

In-PharmaTechnologist takes an indepth look at the new radio frequency identification (RFID) technology that will soon revolutionise pharmaceutical supply chain management.

New online RNA access to speed drug discovery

Biobanking firm Asterand has launched a new online service to offer researchers access to human RNA samples via the internet that it claims could potentially speed up the early stage drug discovery process.

GSK ramping up drug production in Poland

UK drug goliath GlaxoSmithKline (GSK) is ramping up drug production at its Polish site as it prepares to more than double the number of markets the plant will supply.

FDA drug safety tracking system flawed, report says

The Food and Drug Administration (FDA) has failed in its attempt to revamp its flawed drug safety tracking system, the Wall Street Journal reported last week, citing a report commissioned by the agency.

Spray-on contraceptives to penetrate $6.7bn market

Contraceptives delivered by a simple spray onto the skin are being developed in a bid to offer easier, more convenient pregnancy protection.

First anti-psychotic patch in development

Two US companies have teamed up to develop a prototype patch to deliver an existing anti-psychotic drug through the skin.

Zentiva snaps up Eczacibasi generics for €460m

Pharmaceutical manufacturer Zentiva has signed a deal acquiring 75 per cent of Turkish Eczacibasi's generic pharmaceuticals business for €460m, making it the third largest generics company in the country.

Contract manufacturing news in brief

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

Eisai begins building its first European production plant

Eisai has today begun building a £100m (€147m) European headquarters in the UK which will include a new pharmaceutical manufacturing facility - its first production plant in Europe.

Alpharma's APIs benefit from generics sale

Revenues for Alpharma's active pharmaceutical ingredient (API) division went up by around $30m over fiscal 2006, over half of which was generated by products previously part of the company's divested generics business.

Patheon to resuscitate thanks to $150m rescue

Canadian contract manufacturer Patheon has announced a $150m (€114m) investment by a private equity firm - a move the company sees as the best viable option to end its financial misery.

Oral strip for generic Zofran

A new rapidly dissolving oral strip for ondansetron, the active ingredient in GSK's anti-emetic drug Zofran, has been developed in a Swiss-German collaboration.

New vaccine technology holds double promise

A new nanotechnology-based vaccine delivery method could allow the development of single-dose vaccines as well as new vaccines in disease areas of unmet need.

Flood of fake drugs must be stopped, warns UN

The flood of fake drugs now available in many countries must be tackled as it could have fatal consequences for consumers, a new UN report shows.

Bayer confirms over 6,000 job cuts

Bayer Healthcare last week confirmed that 6,100 jobs will be cut in the reshuffle following Bayer's takeover of Schering announced last year.

Alpha results for new cancer radiotherapy

An anti cancer therapy that emits the most lethal from of radiation has successfully made it through second stage human trials.

Contract manufacturing news in brief

Lonza, Athersys, TyRx Pharma, JFC and Precision Pharma Services have all announced new contract manufacturing deals this week.

Implantable/injectable drug delivery market set to hit $12.6bn by 2010

The implantable/injectable drug delivery market generated record revenues of $9.8bn (€7.4bn) worldwide in 2006 but is set to continue growing, driven by growing demand for novel drug delivery technologies.

First six-month cancer dosage introduced to Europe

MediGene's six-month dosage of its prostate cancer drug Eligard (leuprolide acetate) is now available in Germany, the company announced today.

Dry goods batch system operates remotely

A precision batching system for dry goods can be monitored from abroad, providing diagnostics and performance reports to managers working remotely, its manufacturer claims.

High-shrink film covers unusually shaped containers

A new label film designed for narrow neck containers, can combine high-shrink properties with a tamper evident seal, its manufacturer claims.

FDA delays at Wyeth site

Food and Drug Administration (FDA) staffing and timetabling problems have delayed the re-inspection of Wyeth's Puerto Rico site, the company said this week.