Breaking News on Pharmaceutical Technology

EU approval of new Rebif just what the doctor ordered

Merck Serono's new and improved version of its blockbuster multiple sclerosis (MS) drug Rebif (interferon beta-1a) has been approved in the EU, providing a little added protection to the company's MS franchise.

Lonza's China plan taking shape

Lonza's $200m (€147m) investment in China is continuing to shape up as the firm announced its new small-scale exclusive synthesis manufacturing plant will be up and running next month.

Week of drama for PDL Biopharma

PDL Biopharma has seen a week of drama after announcing a restructure that left its key investor calling for the company chairman to resign, a week after its CEO also decided to step down after similar pressure.

Silicon nanowires conduct drugs into cells

New research has shown that silicon nanowires can be used to deliver toxic agents into both human and bovine epithelial cell lines, opening up new options for drug targeting and delivery.

AstraZeneca's schizophrenia drug gets the nod in the Netherlands

AstraZeneca has had its new extended-release formulation of its schizophrenia drug approved in the Netherlands.

Dr Reddy's bets high on biosimilars

Indian drug maker Dr Reddy's is planning to launch one biosimilar every year in the next few years, according to Indian media reports.

SAFC Wisconsin site keeps on growing

In the latest phase of growth at chemical firm SAFC's flagship high potency active pharmaceutical ingredients (HPAPIs) facility in Madison, Wisconsin, the site will be treated to another multi-million dollar expansion and new analytical testing equipment.

Patent changes and the pharma industry

Pharmaceutical companies are being urged to develop strategies in an effort to deal with the controversial new patent rules that come into force in the US in November.

ALK-Abello and Catalent to increase Grazax production

ALK-Abello will be funding a new DKK 300m (€40.3m) production line dedicated to its oral grass pollen allergy vaccine at Catalent Pharma Solutions' UK facility.

Encap expands Scottish drug delivery biz

Scottish drug delivery firm Encap has announced it has kicked off the construction of a new plant in Scotland to meet growing demand for its contract encapsulation services.

Amgen vs. Roche: patent trial to kick off

A US judge has backed Amgen's court motion, ruling that Roche's Mircera infringes one of its composition patents. Roche is standing firm against the allegations.

Novartis Hep C drug clears Phase II

A long-acting biologic being co-developed by Novartis to treat chronic hepatitis C virus (HCV) has triggered a $40m (€29.3m) milestone for its development partner after clearing Phase II trials in April.

Novartis expands on Rasilez news

24 hours after announcing EU approval of its hypertension drug Rasilez (aliskiren), Novartis has unveiled plans for a major expansion to production facilities in Switzerland.

Pharmaceutical manufacturing: people on the move

Pfizer, Cubist Pharmaceuticals, Tikvah Therapeutics, Nucryst Pharmaceuticals and Nektar Therapeutics have all had people on the move in the world of Pharmaceutical manufacturing.

Octreotide prolonged release form ticking all the boxes

Results from a Phase II study of a prolonged release formulation of octreotide look encouraging for the treatment of acromegaly, according to Ambrilia Biopharma.

FDA considers combo allergy pill

A single tablet formulation combining two major allergy treatments has been accepted for review by the US Food and Drug Administration (FDA).

Synthetic MAb purification tech edges closer to market

The UK arm of biopharma company ProMetic has hit a milestone with its breakthrough synthetic molecule solution for protein purification.

First US cell-based flu vaccine plant underway

Novartis last week began construction of a major new flu vaccine manufacturing facility in North Carolina, the very first cell culture-derived flu vaccine plant in the United States.

Measuring bioprocess shear stress

A new device has been developed enabling researchers to study the stability of therapeutic proteins against shear stresses to allow better bioprocess optimisation.

Indian drug manufacturers must clean up their act

New research has branded pharmaceutical manufacturers in India as being responsible for the release of substantial and worrying amounts of active pharmaceutical ingredients (APIs) into the environment.

Billionaire to get bigger Biogen stake?

Investment mogul Carl Icahn could get ready to buy further shares of biotech company Biogen Idec after getting the green light from the competition regulators.

Sanofi-Aventis faces a second patent lawsuit for SoloStar

Sanofi-Aventis has been hit with its second patent lawsuit in two months over its recently released SoloStar insulin pen.

RW Packaging shows six-month growth

Canadian packaging company RW Packaging's six-monthly sales in pharmaceuticals have offset the company's poor sales performance of household and seasonal products.

Pfizer's biologics plans taking shape

Yet another sign of pharma heavyweight Pfizer's moves to break onto the biopharma scene emerged today, with news that the company has signed a multi-million dollar licensing deal to get its hands on US firm Xoma's antibody technology.

Contract manufacturing news in brief

Patheon, Lifeline Cell Technology and SRI International have all recently announced new contract manufacturing deals of late.

GPC feeling the pressure

Just weeks after disappointing news regarding its potential billion-dollar drug satraplatin was swiftly followed by a class action lawsuit against the company, GPC Biotech has announced plans to cut 15 per cent of its workforce.

NICE gives green light to 3 biologics

The UK's drug reimbursement watchdog has given the green light for the first time to a treatment specifically for multiple sclerosis (MS) and also gave the thumbs up to two arthritis drugs, all of which are biologics.

Pharma packaging goes futuristic

A France-based packaging solutions company plans to launch heat-shrink labels with integrated holograms into the pharma industry, in what it believes will be the next big counterfeiting solution for the sector.

New plant fills the gap at Aesica

A new pilot plant at UK firm Aesica's Cramlington site has filled a void in the active pharmaceutical ingredient (API) specialist's offering, allowing them to provide services all the way from Phase I through to product launch.

Liquid chromatography on the up in US

The US market for liquid chromatography is looking 'very promising', according to a new report.

ISPE offers e-archiving advice

A new guide on the prickly issue of electronic data archiving has been published for the pharmaceutical manufacturing industry, the latest offering from the International Society for Pharmaceutical Engineering (ISPE).

Report shows gaps in pharma performance

A study of 50 pharmaceutical lines has uncovered 'substantial gaps' in performance between the more operationally savvy and those with less nous.

Award for preclinical services firm

Domainex, a London- and Cambridge-based preclinical services firm has won an industry award for its bottleneck-breaking genomics technology.

Pharmaceutical manufacturing: people on the move

BioVex, Orexo, Epix Pharmaceuticals and DSM have all had people on the move in the world of pharmaceutical manufacturing.

GSK, MSD move on Singapore schemes

GlaxoSmithKline (GSK) and Merck Sharp & Dohme (MSD) have made further moves in their plans to boost their presence in Singapore, a region growing in popularity for biopharmaceutical research and manufacture.

Vivalis scores another cell culture technology

French biopharmaceutical company Vivalis has added another cell culture technology to its stronghold as it moves to dominate the avian stem cell market.

United Drug makes second EU packaging purchase

United Drug has made its second European contract packaging purchase as the Irish services firm continues to pursue expansion across the continent.

Adams pushes Rx

Adams Respiratory Therapeutics is positive about its plans to build its prescription products portfolio after announcing its financial results for the 2007 fourth quarter and year-end.

Smart Bluetooth-enabled pharma packaging

A global packaging firm has hooked up with a company specialising in electronic disease management solutions to develop a new generation of electronically-enhanced pharmaceutical packaging.

Pfizer expands into biologics

Pfizer announced today it is breaking ground on a $50m expansion of its biologics pilot plant in Chesterfield in a move that comes at time when the drug giant is cutting back in other business areas.

First ever once-a-year osteoporosis drug approved

Swiss firm Novartis has gained US approval of its once-yearly treatment for postmenopausal osteoporosis, with EU approval expected to follow hot on its heels.

Revamped Wyeth drug gets EU go-ahead

An improved version of Wyeth's haemophilia B treatment BeneFix - the only recombinant Factor IX product available on the market - kitted out with a host of new user-friendly features, has been approved in the EU.

TMH sells needle-free insulin biz

The Medical House (TMH) has sold its SQ-PEN needle-free insulin injector business as it moves away from supplying the product to private individuals to focus more on its drug delivery systems business.

Weekly comment

UK tightens Phase I guidelines

The Association of the British Pharmaceutical Industry (ABPI) has now published revised guidelines for Phase I trials in the UK.

Pharmatek bows to cytotoxic trend

Pharmatek Laboratories has now added cytotoxic and high-potent drug development services to its list of contract pharmaceutical offerings.

Nanoparticles and drug delivery gel together

US researchers have developed a nanogel drug delivery system which has the potential for controlled release activity and targeted drug delivery.

Solvay 'still on path' for Creon

Solvay Pharmaceuticals still believed it was on track for meeting US regulatory deadlines for pancreatic insufficiency drugs despite receiving an approvable letter for its own newly formulated drug Creon.

Amgen admits job cuts on way after anaemia drugs drama

Amgen has finally put an end to weeks of rumours and speculations by admitting its plans to slash 12-14 per cent of its workforce to offset the recent difficulties it has been facing with the sales of its anaemia blockbusters.

Millipore, Novo strengthen insulin pact

Danish diabetes care specialist Novo Nordisk has expanded an agreement with biotech supplier Millipore, granting exclusive, long-term distribution rights to the company's insulin products for cell culture applications.

Pfizer pipped to the post by biologics plant announcement

Pfizer was taken by surprise this week as a US engineering firm announced that it had been awarded a contract to manage construction of the firm's proposed biotech production plant in Ireland, before the plant plans themselves have even been approved by internal Pfizer decision makers.

Europe sends flu vaccines to US

Two European vaccine manufacturers have begun shipping influenza vaccines to the US for the 2007/2008 season.

Contract manufacturing news in brief

Pharmstandard, Sancillo, and Althea Technologies have all recently announced new contract manufacturing news.

New depth filter released

US-based Pall Corporation has launched a new depth filter which is disposable and can be scalable from personalized medicine applications to large scale commercial use.

Labelling link-up for pharma manufacturers

A leading software provider to the life science industry has formed an alliance with a specialist supplier of radio frequency identification (RFID) printing and bar code labelling hardware to offer dedicated solutions to pharma, biotech and medical device manufacturers.

Baxter awarded UK pandemic flu contract

Baxter International's UK subsidiary has signed a contract with the UK Department of Health to provide an advanced supply of pandemic influenza vaccine.

Pharmaceutical manufacturing: people on the move

Sapphire Therapeutics, Cytochroma, Xtent and WuXi PharmaTech have all had people on the move in the world of pharmaceutical manufacturing.

Solvay kicks off peracetic acid production in China

Solvay's first Chinese plant for a key chemical disinfectant is now fully operational, serving the growing Chinese market and spreading the international chemical group's global reach ever further.

Weekly Comment

No lack of innovation in pharma, says Wyeth

The often cited decline in R&D productivity and dwindling innovation within the pharma industry is actually a thing of the past, according to Wyeth's head of business development.

Antibody rival drawing investors to Molecular Partners

An award-winning therapeutic protein technology, touted as superior to antibodies, has attracted venture capitalist investment for its owners, the Swiss biotech Molecular Partners.

Mouthwash reformulation delays US launch

The US launch of the hotly touted, next-generation mouthwash, Decapinol, has stalled following the decision to reformulate the US product as a "precautionary measure".

Genmab gains milestone and antibody

Danish biotech firm Genmab has gained an undisclosed milestone payment from Roche and the rights to a second antibody from Merck Serono.

SWATT team helps double flu vaccine output

A Canadian firm that has developed a technology to double the amount of flu virus obtained during traditional egg-based vaccine production is launching a dedicated team to help manufacturers implement the platform and ramp up their production capabilities.

Pharma tops most IP-intensive list

The pharmaceutical industry has come up top in the most Intellectual Property (IP)-intensive industry in the US, according to a report released this week.

Drug delivery keeps eye on the market

A new drug delivery technology is looking promising as it gets its first glimpse of the US market with the launch of the eye drop AzaSite.

LifeCycle gets fenofibrate approval in US

The lowest formulated dose of cholesterol-busting fenofibrate has been approved for the US market using a new formulation platform.

Sartorius Stedim profit decline masks growing biz

Recently formed Sartorius Stedim Biotech has recorded rising sales and new business but a slight decrease in profit in the first half of the year, as it finalises its merger.

IMA investments paying off

Pharmaceutical packaging and processing machinery specialist IMA has announced its half year results, with its active expansion plans paying dividends and its pharma business going strong.

Scottish firm targets South Korea for cancer patch

Scottish company ProStrakan has landed a South Korean partner for its novel transdermal patch for chemotherapy-induced nausea, the firm's first patch product with ambitions to steal a sizeable chunk of a €2bn market.

Invitrogen takes the stress out of stem cell 'passaging'

The launch of Invitrogen's Stempro EZPassage should substantially reduce the time and stress involved in dividing up cultures of human embryonic stem cell (hESC) colonies.

Hikma makes inroads into Egyptian pharma market

UK Hikma Pharmaceuticals has acquired Egyptian pharmaceutical company Alkan Pharma in a deal worth $60.5m (€44.2m), and establishes the London-based company in the Egyptian market.

PerkinElmer expands LC/MS validation service

PerkinElmer has expanded its multi-vendor service offering to help firms reduce the cost of regulatory compliance in pharmaceutical drug development and manufacturing quality control laboratories.

GSK disppointment at FDA Advair decision

GlaxoSmithKline (GSK) has suffered a blow in the advance of its top selling pharma drug Advair after US regulators issued a not approvable letter for an increased strength in the treatment of chronic obstructive pulmonary disease.

Contract manufacturing news in brief

Pharmaceutics International, Eden Biodesign, Laureate Pharma and Cytovance Biologics have all recently announced new contract manufacturing deals.

EU go-ahead for major new growth therapy

French pharma firm Ipsen has gained marketing authorisation for Increlex (mecasermin), the first therapy of its kind to be approved in the EU for long term treatment of severe primary insulin-like growth factor-1 deficiency (IGFD).

Cancer gene therapy gets go-ahead in India

A cell-based gene therapy that can be used for to treat renal cell carcinoma, colon, breast, and lung cancer, has been given permission to be used in Indian patients by the country's regulator.

PerkinElmer reduces the cost of cellular imaging

PerkinElmer has launched an 'introductory configuration' of its Opera system to lower the upfront cost of adding high content screening (HCS) to drug discovery and systems biology programmes.

Australian biotechs in €100m merger

Two Australian biotech firms are about to merge in a deal worth AUD156m (€97m) which could lead to the creation of one of the largest biotechnology companies in the country.

Manufacturing partner for novel PEGylation tech

A UK firm responsible for developing an innovative PEGylation technology has landed a deal with a Canadian specialty chemicals firm, allowing them to offer a complete package to companies looking to work with the new technology.

NIAID awards vaccine contracts

Two US life sciences companies have been awarded contracts from the National Institutes of Allergy and Infectious Diseases (NIAID) to develop vaccines.

Vivus hits menopause milestone

US pharma firm Vivus is the happy recipient of a $140m milestone payment following last month's decision by US regulators to approve a novel spray-on estrogen treatment for menopausal women.

IBM launches ePedigree system

IBM has launched a new ePedigree system to attack the problem of drug counterfeiters and to help companies adhere to the emerging track and trace regulations.

GPC tries to stay positive after satraplatin blow

GPC Biotech announced its second quarter financial results this week, trying to put a brave face on its outlook despite the recent disappointments regarding its lead oral cancer drug.

Biotech firm Archemix strengthens alliances

Following Archemix' initial public offering (IPO) filing the company has announced two high profile strategic alliances aimed at leveraging its aptamer technology to a wider audience.

Cambrex profit rises despite flat sales

Cambrex has recorded an increase in operating profit in its second quarter financial results despite flat sales.

Weekly comment

Speculation on gene therapy trial death 'premature'

Targeted Genetics said it was 'premature as well as irresponsible' to draw any conclusions on what caused the death of a patient who participated in a clinical trial testing the safety of the firm's new gene therapy.

Gilead scraps new plant to acquire Nycomed facility

US-based Gilead Sciences has ditched its plans to build a new €60m plant in Dublin, Ireland, instead acquiring Nycomed's Irish manufacturing facility in Cork for almost €34m.

Pharmaceutical manufacturing: people on the move

Amgen, Watson Pharmaceuticals, Abbott, Sigma-Aldrich and BioCryst have all had people on the move in the world of pharmaceutical manufacturing.

Viracept continues to spiral

The latest act in the Viracept (nelfinavir) debacle has seen Roche officially lose marketing authorisation for the HIV treatment, following reports of high levels of genotoxic contamination in the drug.

Biopharma sector: people on the move

Amgen, Ambrx, BioCryst Pharmaceuticals and Xchem have all had people on the move of late in the biopharma world.

Baxter recalls more infusion pumps

Baxter Healthcare remains in murky waters in regard to its infusion pumps after announcing yesterday it would be recalling an additional 986 of its Colleague brand pumps.

Generics gnaw at Biovail profits

Canadian drug delivery specialist Biovail has reported its second quarter financial results, revealing the pressure generic competition is exerting on the company's coffers.

GSK increases H5N1 vaccine presence in US

GlaxoSmithKline (GSK) is bolstering its pandemic H5N1 vaccine presence in the US after being awarded a contract to provide 22.5 million doses of bulk antigen to the US stockpile while launching clinical trials for its adjuvanted H5N1 vaccine.

Bayer, Nektar in antibiotic agreement

Bayer HealthCare has joined forces with US firm Nektar Therapeutics to develop a new inhalable antibiotic for the treatment of acute pneumonias.

Outsourcing-Pharma.com special focus

Court sanctions independent trustee for Inyx USA

A US bankruptcy court judge ruled on Friday that Puerto Rican-based pharma services firm Inyx USA be put under the control of an independently-appointed trustee.

Celsis tech gets pharma recognition

Celsis' Rapid Microbiological Method (RMM) has been included in GlaxoSmithKline's (GSK) successful Veramyst New Drug Application (NDA), paving the way for broader acceptance of the time saving technique.

QDose closes in on Exubera

An improved inhalable insulin product developed by collaborating UK and US firms has just completed a glucose clamp study in the US, with results suggesting that the product could pose a significant threat to Pfizer's Exubera franchise.

Novo Nordisk half-year profit boosted on cancer unit sale

Novo Nordisk has reported a 60 per cent jump in pre-tax profit to DK6.8bn (€0.9bn) for the first half of 2007, boosted by the earlier sale of its cancer diagnostics business.

Electroporation delivery system wins biothreat contract

San Diego-based Ichor Medical Systems has been awarded a more than $2.3m contract to develop an electroporation DNA vaccine delivery system for anthrax and plague in the event of bioterrorism.

West to cut production of Exubera devices

West Pharmaceutical Services have been informed to scale back production of Exubera devices following the dismal revenues the inhalable insulin product has generated so far this year.

Vesanoid with bovine-derived material recalled in Japan

Japan's Chugai Pharmaceuticals is voluntarily recalling almost 2000 bottles of Vesanoid capsules (tretinoin) after the drug was found to contain unapproved bovine-derived material from Canada.

Allegra and BMS deal boost AMRI Q2 profit

Albany Molecular Research Inc. (AMRI) has posted encouraging financial results in the second quarter of the year, boosted by both bigger royalty payments and steady growth in its contract business.

Stada boosts production power with Russian pharma acquisition

German pharma firm Stada has acquired Russian pharmaceuticals group Makiz in a deal worth up to €135m, giving the company a sturdy foothold in the growing Russian market and enhanced in-house production capacity.

Viagra, Cialis imitations seized in London raid

In the latest episode of illegal drug trading, a hoard of unlicensed medicines was seized by the UK Medicines and Healthcare products Regulatory Agency (MHRA) last week, taken from a London lock-up containing a stash of various male impotence drugs.

Skyepharma forced to delay NDA in US

SkyePharma will be delaying its New Drug Application (NDA) in the US for its asthma treatment Flutiform following an "unexpected" setback in the submission process.

Outsourcing-Pharma.com special focus

Latest twists and turns in Inyx saga

The latest twists and turns in the Inyx Inc. bankruptcy saga include an attempted power seize by its creditor, fraud allegations thrown around courtrooms and in the media, the resignation of Inyx' accountants, and increasing signs of links between Inyx and a company called Karver.

Illuminating the future of drug delivery

Irish researchers have developed a technique that could be used to deliver controlled amounts of drugs to diseased tissues while minimising side effects simply by shining light on the target.

Statin-based drug touted as Tamiflu rival

A statin-based drug candidate is being touted as a potential rival to Roche's flu vaccine Tamiflu (oseltamivir phosphate) after its developers revealed yesterday that it showed "superiority" in the preclinic.

Genentech completes its first-ever acquisition

US biotech giant Genentech has announced it has completed its first-ever acquisition, buying Tanox for $919m (€672m).

First ever non-contact process protects film-coated tabs

Solid-dose specialist Colorcon has hooked up with materials science firm DataLase to develop a new no-touch on-tablet marking technique specifically for film-coated tablets, helping to defend branded tabs from counterfeiting attempts and protect patient safety.

Teva strides ahead in Q2

Generics giant Teva has announced results for the second quarter of the financial year showing record-breaking sales, thanks to an impressive performance from MS drug Copaxone (glatiramer acetate) and the early launch of generic Lotrel (amlodipine and benazepril).

Lonza pushes biopharma portfolio

Switzerland-based Lonza is establishing its biopharma portfolio with the acquisition of Zyentia's Aggresolve technology this week.

Invitrogen Q2 growth strong

Invitrogen has announced its second quarter financial results with the BioDiscovery business unit showing a greater than expected growth.

CSL Behring invests $15m in Kankakee expansion

CSL Behring is investing in a new $15m expansion of its Kankakee plant in Illinois.

Brookwood delivers for SurModics

US firm SurModics has acquired fellow drug delivery specialist Brookwood Pharmaceuticals in a deal worth up to $62m.

GPC Biotech withdraws satraplatin NDA

GPC Biotech has withdrawn its hotly touted satraplatin New Drug Application (NDA) for accelerated approval following last week's less than glowing recommendation to hold off on its approval.

Tysabri gets preliminary nod for Crohn's in US

In what may come as a surprise to some, a US Food and Drug Administration (FDA) Advisory Committee has recommended the approval of Tysabri (natalizumab) for a new indication - Crohn's disease.

OSG strips contract manufacturing biz

Outsourcing Services Group (OSG) has announced it has sold its contract manufacturing subsidiary OSG Norwich Pharmaceuticals to a US private equity firm for an undisclosed amount.

Pharmaceutical manufacturing: people on the move

Sanofi Pasteur, Point Therapeutics, Amira Pharmaceuticals, Elusys Therapeutics and Chesapeake Pharmaceutical Packaging have all had people on the move in the world of pharmaceutical manufacturing.

Rexam O-I purchase complete amid muted H1 results

UK packaging firm Rexam has today announced the completion of its acquisition of the plastic packaging arm of US company O-I, shortly after releasing somewhat lacklustre results for the first half of the financial year.

Johnson & Johnson slashes jobs, closes facilities

Johnson & Johnson (J&J) has become the latest big pharma player to cut jobs and close facilities, in another example of the changing face of the industry landscape.

Wyeth positive about Pristiq

Wyeth executives are remaining positive Pristiq (desvenlafaxine) will eventually be approved as a treatment both for depression and vasomotor symptoms associated with menopause despite recent setbacks.

Abraxis adds more manufacturing muscle

Abraxis BioScience has snapped up another manufacturing plant in its drive to expand production capabilities, this time announcing the purchase of Watson Pharmaceuticals' sterile injectables plant.