Breaking News on Pharmaceutical Technology

Schott shrugs off downturn with sales, earnings hike

Germany’s Schott Glass posted a 4 per cent increase in revenues during fiscal 2008, bringing in €2.23bn across its divisions.

GSK ceases political contributions

GlaxoSmithKline (GSK) is stopping making corporate political contributions as part of its transparency drive but employees can still donate through the Political Action Committee (PAC).

The big five of 2008

in-PharmaTechnologist takes a look back over the past 12 months, rounding up our five most read stories of the year.

Pfizer licenses gene knockout tech

Pfizer has gained a license for the use of certain ZFP Nuclease (ZFNs) reagents from Sangamo BioSciences, which it will use to modify Chinese Hamster Ovary (CHO) cell lines.

EU wholesalers express concern with pharma package

The European Association of Pharmaceutical Full-line Wholesalers (GIRP) says it has concerns about the anti-counterfeiting proposals contained in the European Commission's recently-released 'pharmaceutical package.'

Video season's greetings from Decision News Media

The Decision News Media team would like to bring you its seasonal greetings in person and show you around the offices.

Merck takes charge of Stimuvax manufacture

Merck Serono has stumped up $13m (€9m) to add manufacturing rights to its Stimuvax licensing deal with Oncothyreon and buy up any remaining inventory of the candidate lung cancer vaccine.

News in brief

USP enters into MOU with UK body

The US Pharmacopeia (USP) has entered into a Memorandum of Understanding (MOU) with the UK National Biological Standards Board to improve the quality of medicines.

$20m heat activated delivery tech deal

Yakult Honsha has gained the exclusive Japanese licensing rights for Celsion’s ThermoDox drug delivery platform, which uses heat activated liposomes that break down above a certain temperature.

FDA beams approval of cancer therapy

Ion Beam Applications (IBA) has said it has received US Food and Drug Administration (FDA) approval for its Pencil Beam Scanning (PBS) cancer treatment.

Exclusive interactive map of employment ups and downs in 2008

We present a unique concept in pharmaceutical journalism; our interactive map tracking the job losses, facility closures, expansions and openings that took place in the US in 2008. Zoom in, roam around and discover details about each individual event.

Analysis of 2008’s shifting employment patterns

To accompany the map detailing job losses, which can be viewed here , we have picked out the details and trends from the data, uncovering the state of US pharmaceutical employment in 2008.

EU action yields record counterfeit haul

The European Union’s coordinated clamp down on counterfeit drugs has resulted in hauls far exceeding expectations, with 34m pills seized in two months.

Siga poised for trials as US focuses on bio-terror

The completion of trial batches of Siga Technologies’ smallpox treatment ST-246 could not have been better timed following as it does the recomendation that the Obama government raise the threat of bio-terror up its list of concerns.

MonoSol targets MENA through Hikma deal

MonoSol Rx and Hikma are teaming up to sell thin film pharmaceutical products in the emerging Middle East and North African (MENA) drug markets.

Burgopak partners to sell award winning packs in US

McKesson RxPak has entered into a partnership with Burgopak, to provide the latter’s compliance packaging to companies in the US.

HHS calls for employer role in flu drug stockpiling

The US HHS says that healthcare workers and emergency service personnel should be given antivirals before this year’s flu season or any pandemic kick in and also calls for the private sector to take more of a role in stockpiling.

Biotech goes cap in hand to government

Biotech bodies from around the globe have been calling on their respective governments to provide stimulus packages to compensate for the current difficulties in obtaining credit.

News in brief

GE launches scaleable chromatography system

GE Healthcare has launched a liquid chromatography system, ÄKTAready, for process scale-up and production of drugs from Phase I through to commercial scale.

News in brief

Medicago invests to increase H5N1 vaccine production

Medicago is investing $1.5m to expand its manufacturing facility in Quebec, Canada, as it attempts to ramp up production to ensure supply for its clinical trials.

Philips’ acquisitions boost nebulizer business

Philips Home Healthcare Solutions has had a busy week, acquiring an Italian aerosol therapy business from Medel and a manufacturing facility in Guandong, China.

Santa not the only person with the sack this Christmas

Festive cheer is a scarce commodity in the drug industry this December as B-MS, Jazz and Arpida cut jobs, falling into step with Pfizer and Elan which each announced a round of redundancies in the last few days.

FDA guidance on genotoxic impurities

The FDA has issued draft guidance on how manufacturers should evaluate the safety of products that contain genotoxic and carcinogenic impurities.

RF drug delivery device gains CE mark

TransPharma Medical has received the European CE mark for its transdermal drug delivery device ViaDerm, which creates pores to allow a therapeutic through the skin.

News in brief

Pakistan aims for $500m exports; raise standards

The Pakistani pharmaceutical industry is aiming to export $500m worth of products by 2013, according to the Pakistan Observer, an increase of 500 per cent on current levels.

News in brief

ProMetic inks $35m adsorbent deal

ProMetic BioSciences has signed a $35m supply agreement with a leading European biopharmaceutical company, under which it will provide one of its proprietary affinity adsorbents.

Helsinn’s Irish trial supplies site cleared

Helsinn’s facility in Dublin, Ireland has been cleared to package, test and store clinical trial supplies by the country’s medicines board, expanding on the US FDA approval it gained earlier this year.

CTx selects IDBS for drug development kit

Australian drug development firm Cancer Therapeutics (CTx) has selected IDBS’ E-workbook and ActivityBase platforms to manage its global drug development programmes.

News in brief

Aeropharm selects Prosonix for crystallisation

German inhaled drug specialist Aeropharm will use Prosonix’ sonocrystallisation technology to develop generics in its candidate pipeline.

Alcan to close Syracuse plant

Alcan Packaging’s decision to close its packaging production facility in Nebraska, US, at a cost of 71 jobs, follows just weeks after parent company, Australian mining giant Rio Tinto, announced some 14,000 lay offs.

Race for Commissioner hots up

The race to be the next FDA Commissioner is becoming increasingly competitive, with candidates jostling for position and interested parties attempting to influence proceedings.

Schott boosts German pharma glass capacity

Schott plans to add two giant glass melting tanks at its facility in Mainz, Germany, continuing the expansion of pharmaceutical tubing production capacity and creating 135 new jobs in the process.

News in brief

Sierra Leone seizes counterfeits

The Sierra Leone Pharmacy Board has destroyed over $400,000 worth of counterfeit drugs in its attempts to cleanse the nation of the problem, according to Awoko.

News in brief

Indian drugs increasingly seized in EU

Shipments of drugs manufactured in India are increasingly being seized by authorities when the vessels dock in Europe on route to Latin America, according to Livemint.

EU ‘pharma package’ sees big changes for pharmacovigilance

At the heart of Europe’s new ‘pharmaceutical package’ are measures designed to improve patient protection through better safety monitoring.

Elan cuts staff and offices as Tysabri wavers

Irish drugmaker Elan, which recently dropped plans to sell its Elan Drug Technologies operation, has announced job cuts and the closure of offices in a bid to save cash.

Pharmaceutical package: no repackaging ban, but shift towards DTC

The European Union’s long-awaited reform of pharmaceutical regulations known as the ‘pharmaceutical package’ was unveiled yesterday after months of consultation and debate.

Generic sales growth slows for 1st time in years

The sales growth of generic drugs slowed considerably in 2008, dipping below the customary double digits to 3.6 per cent, according to a report by IMS Health.

Quadro aims to make trails in powder processing

Quadro Engineering has entered into a partnership to distribute Micro-Macinazione’s Jet-Mill products in the Americas, as well as launching its own API sifter.

News in brief

Hospira initiates voluntary recall

Hospira has initiated a voluntary recall of one lot of its sodium chloride injection, USP as an incorrect barcode label meant medication errors could occur.

Valeant’s efforts in dermatology market: DPS buy

Valeant continues its spending spree with the $285m acquisition of California-based research dermatology specialist Dow Pharmaceutical Sciences (DPS), in a further bid to cement its market position.

Light microscopy technique for improving contaminant analysis

The timely identification of contaminants in pharmaceutical manufacture can be critical to avoiding costly delays. While it is relatively straightforward to establish the composition of a contaminating particle, determining its origin in the manufacturing process can be much more problematic. in-PharmaTechnologist spoke with McCrone Associates' Heidi Ullberg at this year's AAPS in Atlanta about a light microscopy that can help drugmakers address this problem.

Pall hopes to have manufacturing in the bag

Pall Life Sciences has launched its Allegro 3D biocontainers, which have been designed to improve the performance of the company’s large-scale, single use manufacturing systems.

Merck launches biogenerics business

Merck & Co is moving into the follow-on biologics market as it searches for new revenue streams to reduce the damage caused by generic competition.

News in brief

3M licenses dry powder inhaler platform

3M Drug Delivery has exclusively licensed Cambridge Consultants’ Conix Dry Powder Inhaler (DPI) technology platform.

Kemwell forges consumer health partnership with GSK

GlaxoSmithKline has gone into partnership with Indian contract manufacturing and development services company Kemwell to set up an R&D facility aimed at developing new oral healthcare products.

Delays to track and trace laws affect Domino

Efforts to sure-up pharma track and trace rules and combat counterfeiting are a significant opportunity for specialist labelling firms, but the pace of change is proving to be a frustration, according to Domino Printing Sciences MD, Nigel Bond.

The advent of Touch & Talk’s packaging compliance calendar

US firm Touch & Talk Software (TTS) hopes that compliance benefits offered by its new automated ProPacker 30CP calendar blister packaging system will be attractive to clinical trials companies and contract packagers alike.

News in brief

Merck challenged to re-evaluate waste water

Virginia’s Waste Control Board has challenged Merck to create different ways of achieving compliance with 2011 environmental standards, according to the Rocktown Weekly that is based in the state.

Crunch causes ripple effect in Europe’s pharma water sector

Demand for pharmaceutical manufacturing grade water in Europe shows no sign of drying up, according to a new study by industry analysts Frost & Sullivan.

Actavis to divest Bulgarian manufacturing site

One of Actavis’ Bulgarian production facilities is being bought out by the management, which will provide contract manufacturing services to the generic maker and other companies.

Indian government acts to promote biotech

India’s industry has been boosted by news that 20 more biotech parks are to be set up and financial actions are being implemented to help small businesses.

NanoVic’s 24-carat insulin delivery idea

Although it is widely acknowledged that medical bracelets can be the difference between life and death, Australia’s Nanotechnology Victoria (NanoVic) has become the first to take the idea further with its insulin-delivering jewellery project.

Judge warns Commission over patent changes

A UK judge has warned against the European Commission making rash changes following its report into big pharma blocking generics, arguing that it could damage development of new drugs.

Norres claims clamp holds firm under pressure

Germany-based Norres has launched a new clamp system for externally corrugated hoses, which it claims will remain secure even in high pressure conditions.

Departure debacle: Hermelin and KV part company

KV Pharmaceuticals’ long-serving CEO Marc Hermelin has either been sacked or has retired, depending on which party’s version of events one believes, and is being replaced by David Vliet CEO of the company’s Ethex division on an interim basis.

Haemacure seeks ruling in Hemaseel dispute

Haemacure is calling for the International Court of Arbitration in Paris, France to force CSL Behring to make a $1.5m milestone payment that it believes is now due under a 2002 settlement related to firms’ disputed Hemaseel project.

News in brief

UK court throws out SFO price fixing appeal

The Court of Appeal in London has rejected an SFO bid to re-open its long running case against five generics firms that it alleged had defrauded the National Health Service (NHS) of £120m through price-fixing.

Cooperative manufacture of biologics; FDA guide

Final guidance on the cooperative manufacture of licensed biologics has been issued by the FDA, which gives companies an outline of how to share responsibilities through the production process.

Common confusions on the supply chain

Common misunderstandings in the steps needed to ensure raw materials are free from contaminants were part of a speech at this year’s AAPS.

DSM to make NicOx’ naproxcinod API

Life sciences firm DSM has landed the contract to manufacture supplies of NicOx’ much vaunted anti-inflammatory agent naproxcinod and looks good for the long term deal.

News in brief

Eisai’s UK investment to create 300 UK jobs

Eisai says that its £60m expansion of its R&D facility in Hatfield in the UK will create 300 new jobs, swelling its workforce to 500.

Latest research into heparin delivery

The latest research into the delivery of heparin was on display at this year’s AAPS, demonstrating the work that has been undertaken to improve administration methods.

Drug delivery laser aims to P.L.E.A.S.E.

Pantec Biosolutions has received CE marking for its painless laser epidermal system (P.L.E.A.S.E.), which it claims can facilitate transdermal delivery of high molecular weight drugs.

GSK to cut 200 jobs ahead of generic Zofran

UK drug giant GSK is to shed 200 jobs at its manufacturing plant in Barnard Castle, County Durham to cut costs ahead of generic competition for products made at the facility, which include the anti-emetic Zofran (ondansentron).

News in brief

DEG poisoning claims yet more victims in Nigeria

Diethyleneglycol (DEG) has reared its ugly head again, causing up to 25 deaths in Nigeria so far this year according to a November 28 article on the allAfrica.com website.

News in brief

Qatar and Egypt plan new drug plant

Qatar and Egypt are to set up a new drug manufacturing plant at a facility in Qatar, according to BusinessIntelligence. The new facility will begin by producing soluble drugs for the emerging Qatari and Egyptian drug markets.

JAMA study reignites branded versus generic debate

A study in the Journal of the American Medical Association (JAMA) claiming there is no evidence that brandname cardiovascular drugs are superior to their generic counterparts, despite claims to the contrary.

Actavis selects Malta as Africa waypoint

Icelandic generics firm Actavis plans to use Malta as a distribution hub for the supply of drugs to the emerging African pharmaceutical market, according to reports in the Maltese press.

News in brief

Titan lays off 40% of workforce

Titan Pharmaceuticals is to lay-off 40 per cent of its workforce at it attempts to lower operating expenses and preserve capital.

News in brief

NAFDAC launches counterfeit raid

Nigeria is continuing its battle against counterfeit medicines, closing down nine illegal pharmacies and seizing drugs valued at a little less than $850,000.

Roundtable discusses creating a biogeneric pathway

The challenges in establishing a regulatory pathway for biogenerics were discussed at a recent FTC roundtable, with a FDA official saying in most cases it will be “impossible” to establish that the APIs are identical.

Domino’s unveils 5” printhead at Embellage

Domino Printing Sciences chose this year’s Emballage world packaging exhibition in Paris, France to showcase the new 5” printhead it has developed for its V300+ thermal transfer printer.

Cheap ARVs to spark manufacturing in African

Research into developing manufacturing methods to produce cheap antiretrovirals in Africa has been highlighted on World Aids Day by The Council for Scientific and Industrial Research (CSIR).

Dow’s foam granulation used in second B-MS candidate

News that US drugmaker Bristol-Myers Squibb (B-MS) is using its Foam Granulation Technology (FGT) to develop a second drug has worked formulation specialist Dow Wolff Cellulosics (DWC) into quite a lather.

Specialists turn to R&D in tough economic times

As more and more delivery firms set their sights on the specialty pharma sector, existing specialty players are increasingly abandoning established licensing strategies in favour of developing drugs in-house to compete.

Penwest seals drug delivery deal

Penwest Pharmaceutical’s TIMERx drug delivery technology is to be used to develop one of Otsuka Pharmaceutical’s compounds under a new deal.

FDA official gives insight into heparin case

Following fresh criticism of the agency’s handling of the heparin case, in-PharmaTechnologist reports on a FDA official’s explanation of the what, the when and the why of the scandal, from first deaths to continued vigilance.

Big Pharma’s generic delaying tactics costs patients €3bn, says EC

Competition commissioner Neelie Kroes said that some drugmakers operating in the EU are deliberately stalling the introduction of generics, costing European patients around €3bn ($3.87bn) a year more to buy medicines.

News in brief

UPM opens China RFID plant

UPM Raflatac hopes its new RFID facility in Guangzhou, China will strengthen its market position as the country’s drugmakers seek to improve their international reputation and increase exports.

News in brief

Sewtec’s new labelling platform works with single and multipacks

Sewtec claims that its new LX5194 Labelling System is the first to be compatible with both single and multipack cartons, enhancing the flexibility and speed with which manufacturers can switch between production runs

News in brief

RFCL’s Mallinckrodt take over now uncertain?

Economic uncertainty may have scuppered Ranbaxy Fine Chemicals’ efforts to buy US chemicals rival Mallinckrodt Baker, according to a report in India’s Economic Times.