Breaking News on Contract Research, Manufacturing & Clinical Trials

NERI and ProMedica team up to offer Ph I-IV research solutions

US CROs NERI and the ProMedica Clinical Research Center have teamed up to offer comprehensive Phase I-IV trial services to the drug industry.

BKK sets up in Japan to combat recruitment lag

US Patient recruitment specialist BBK Worldwide has set up a unit in Osaka, Japan to improve enrolment rates for studies in the country and help local pharma and biotech firms cut costs.

News in brief

Ex-Cardinal execs accused of fraud

The US Securities and Exchange Commission (SEC) has accused three former senior executives and accounting officers at Cardinal Health of securities fraud for falsely portraying company results.

TMD adds mutation assays to bolster cancer services

Targeted Molecular Diagnostics (TMD), which was acquired by Quintiles in November 2008, has launched two mutation assays to help clients develop more effective, personalised cancer treatments.

20 years of clinical trial globalisation - interactive feature

In an exclusive feature combining interactive maps with written analysis Outsourcing-Pharma explores the spread of FDA registered investigators beyond the US’ border over the past 20 years.

Ockham and etrials team up on EDC

US CRO Ockham Development group will start providing customers with data capture and analysis solutions developed by etrials under a new, five year licensing agreement.

Patheon starts legal action against JLL

Contracting giant Patheon has started legal action to restrict the voting rights of private equity group JLL Holdings, in the latest move of an increasingly acrimonious takeover battle.

News in brief

Lonza signs big pharma deal

Lonza has inked a deal with a big pharma that will see the Swiss-based CMO use its microreactor technology (MRT), which it claims can boost yield, cut changeover time and reduce solvent use.

Pharma outsourcing: people on the move

Outsourcing-Pharma provides its latest round up of movements in the pharmaceutical outsourcing sector, including an executive reshuffle at PPD that caused share price to dip.

Big not always best for biotechs using CROs

Biotechs use smaller CROs as much as larger service providers and regard patient recruitment speed as by far the most important characteristic, according to a report.

Fate seeks partners to be iPS Catalyst

There has been “tremendous interest” in Fate Therapeutics’ Catalyst programme, which gives access to induced iPS cell technology as part of collaborative relationship between numerous companies.

KAHR hoping to benefit from Cobra’s tech

At BIO 2009 Cobra Biomanufacturing explained to Outsourcing-Pharma its maxXpress service, its thoughts on expanding to commercial scale and the recent deal with KAHR Medical.

News in brief

Almac to work with Pfizer on expression analysis

Almac Diagnostic will use its disease specific assay (DSA) expression profiling technology to help US drug giant Pfizer identify cancer patients who a most responsive to treatment.

Upfront boasts 60% yield boost in processing step

CMO Richter-Helm BioLogics has achieved a 60 per cent increase in yield using technology from Upfront Chromatography, which demonstrated its system at BIO 2009.

Charlesson’s CRO helps in-house activities

Outsourcing-Pharma met with Charlesson to discuss the company’s business model, which sees its in-house activities benefit from revenues, experience and contacts generated by its preclinical service offering.

Neuland posts big growth despite downturn

Neuland has posted a 35 per cent growth in operating profits in its 2008 financial year, despite the pricing pressures and economic environment that have affected the industry.

Hovione to invest €2m in nano drug R&D unit

Portuguese contract manufacturing organisation (CMO) Hovione plans to invest €2m ($3m) in a new R&D unit in the capital Lisbon, as expansion space at its active pharmaceutical ingredient (API) plant in Loures is limited.

Healthcare reform could suffocate innovation; BIO 2009

Karl Rove and Senator Tom Daschle were among the political figures at BIO 2009 discussing how the US healthcare system should be reformed, which some believe could have grave consequences for medical innovation in the country.

Lonza to set up Singapore cell therapy plant

Swiss biomedical science firm Lonza is investing CHF30m (€19.7m) in a new cell therapy facility in Singapore, continuing its global expansion effort.

Minakem adds EU API capacity to compete with Asia

Fine chemicals firm Minakem believes that manufacturing capacity added by its newly acquired API plant in Dunkirk, France will reduce costs and help it compete on a global scale.

BerGenBio RNAi services attract biotechs

BerGenBio is at BIO 2009 presenting its CellSelectRNAi technology and other services, which in the four months the company has been operational have landed it a multi-million dollar deal with a "big blue-chip pharma".

Quotient Bioresearch buys Edinburgh facility and sets up new clinical unit

UK CRO Quotient Bioresearch has bought a clinical research facility in Edinburgh, Scotland, which in conjunction with an existing unit in Nottingham, England will serve as a base for its new Quotient Clinical unit.

Patheon aims to be "provider of choice" for cell assays

Canadian contract services group Patheon will roll out a cell based assay offering that it says will help the biopharmaceutical sector advance the development of the next generation of biologic drugs.

BerGenBio presents CellSelectRNAi tech at BIO 2009

The Norway-based company was spun out of Bergen University a few months ago but its tools, which it believes give more information on a target than any other currently available tech, have already attracted interest from biotechs in Europe, the US and Asia.

Piramal adds trial packaging and distribution capacity at UK plant

Piramal Healthcare’s new clinical trial manufacturing, packaging and distribution centre in Northumberland, UK will help pharma industry customers to “build cost saving at an early stage,” according to European strategic manager Martin Hunt.

Interactive treemap of the shifting clinical trial environment

Outsourcing-Pharma presents a unique visual analysis of the globalisation of clinical trials and rise in CROs in the past 20 years, using an interactive treemap to explore the trend

Telstar unveils vial unloading system at Achema

Telstar unveiled a range of products at Achema 2009 in Frankfurt, Germany last week, including its compact unloading system that forms part of its automatic vial loading system and aims to minimise installation space.

The rise and spread of CROs – interactive feature

Outsourcing-Pharma explores the rise and globalisation of contract research organisations (CRO) through exclusive interactive graphics, providing a unique perspective on the industries major players.

WuXi operating income down 25% in Q1

WuXi PharmaTech’s operating income fell by 25 per cent in Q1, in part because of an 81 per cent drop in revenues from manufacturing, but the company reconfirmed its 2009 financial guidance.

Severance pay hits Datatrak in Q1

eClinical provider Datatrak has posted flat revenues in Q1 but its operating loss was badly affected by the severance packages of two executive officers.

Filling machines dominate Bosch’s busy Achema launch programme

A new 9,500 unit per hour sterilised syringe filler was a highlight of Bosch Packaging Technology’s busy programme of machine launches at Achema 2009 in Frankfurt, Germany this week.

News in brief

Growth predicted for Indian 3PL market

Indian companies’ greater use of third party logistics (3PL) is predicted to drive the market in coming years, helping revenues rise from $1.5bn (€1.1bn) in 2008 to $4bn in 2012, according to industry analyst RNCOS.

NJ slams FDA on conflicts of interest

New Jersey’s attorney general has called on the FDA to stop the “rampant undisclosed financial conflicts of interest” in clinical trials.

Global trials call for global ethics, says NEJM study

The increasingly global clinical trial sector demands more effective ethical and regulatory scrutiny according to a study published in the latest edition of the New England Journal of Medicine (NEJM).

News in brief

ERT relocates to accommodate growth

eClinical service provider ERT has relocated to a facility in Philadelphia, US that is double the size of the previous site.

Pharma outsourcing: people on the move

Outsourcing-Pharma provides its latest round up of movements in the pharmaceutical outsourcing sector, including appointments at WuXi and OmniComm.

Encorium to sell US and Finnish units

CRO Encorium has unveiled plans to sell both its US business and its Finnish subsidiary Encorium Oy just weeks after posting a gloomy set of Q1 financials dominated by a 15 per cent drop in net revenues.

PDI’s losses mount in Q1

PDI posted a larger operating loss in Q1 2009 than in the previous year, with the company blaming the decline on the expiration, termination and postponement of contracts.

Wil Research cuts 4% of workforce to weather global gloom

US non-clinical contract research firm Wil Research Laboratories has reduced its 700 strong workforce by 4 per cent, citing a drop in business due to the global economic downturn as the basis for the cuts.

Wireless drug delivery tech targets compliance

Cambridge Consultants has developed its ‘connected patient’ technology, which creates a communication network between drug delivery devices and healthcare professionals to increase compliance.

News in brief

Rottendorf Pharma completes pilot plant

Rottendorf Pharma has completed its development and upscaling pilot plant, which will complement its other sites that provide manufacturing and packaging services.

Sanofi hires Pilgrims to guard facility

Sanofi-Aventis has expanded its collaboration with Pilgrims to include its Dagenham, UK facility, which will now be guarded by the security services company.

Agilent expands oligonucleotide manufacturing services

Agilent has completed the second expansion of its nucleic acid active pharmaceutical ingredient (API) manufacturing facility, which is intended to meet rising demand for oligonucleotide-based drugs.

West and Vetter team up on new drug reconstitution syringe

A new ready-to-use WFI prefilled syringe for the reconstitution of lyophilised drugs is likely to win fans among producers of high-value biopharma drugs according to West Pharmaceutical Services’s VP of European marketing, Mike Schaefers.

BioClinica to buy etrials

BioClinica is continuing its expansion in eClinical by proposing to acquire etrials, which underwent significant restructuring in 2008 but still suffered repeated quarterly losses.

SCM wins Sanofi fill/finish contract for radiolabelled Ph III candidate

UK CMO SCM Pharma, which specialises in the handling of volatile materials, has won a contract to fill and finish a radiolabelled oncology drug on behalf of European drug major Sanofi Aventis.

Mass loan boosts Wolfe’s facility

Wolfe Laboratories (WLI) has been given a $500,000 (€375,000) loan by the Massachusetts Life Sciences Center (MLSC) to construct the first stage of an aseptic fill/finish manufacturing facility.

PharmaTek OKed to make cytotoxics at San Diego plant

US chemistry firm PharmaTek Laboratories has a green light to start making high potency APIs and cytotoxics at its facility in California after meeting strict safety and control rules that govern their production.

FDA rules on adaptive trials would help sector, says PI

Definitive FDA guidance on adaptive trials cannot come soon enough for the pharmaceutical and biotech sectors, according to Perceptive Informatics (PI).

News in brief

CMED and Tessella team up on trials

CRO CMED and IT group Tessella are teaming up to offer adaptive trial data management and acquisition services to the drug industry.

Cisiv launches Baseline Plus for "real world" trials

UK software group Cisiv has unveiled a web-based EDC platform, Baseline Plus, which is specifically tailored to meet the demands of post market trials.

Charles River maintains 2009 guidance; preclinical orders “stabilise”

Charles River Laboratories (CRL) has bucked the CRO sector trend and reaffirmed its forecasts for 2009, citing an improved order book and better pricing as the reasons for its relative optimism.

Eurotrials hires AmeriStart for US promotions

CRO Eurotrials has brought in US business consultant AmeriStart to publicise and sell its trial services to pharmaceutical and biotech firms in North America.

Eurotrials hires AmeriStart for US promotions

CRO Eurotrials has brought in US business consultant AmeriStart to publicise and sell its trial services to pharmaceutical and biotech firms in North America.

AstraZeneca becomes Jubilant’s latest JV partner

AstraZeneca (AZ) has become the latest company to enter into a research collaboration with Jubilant, with the companies initially focusing on delivering preclinical candidates in the neuroscience area.

Hospira calls time on US biogenerics delays

Drug delivery specialist Hospira has set up a “biologics clock” that counts the amount spent on cell culture-derived medications in the US in a bid to highlight the potential savings greater use of generics could provide.

Catalent expands capacity at Irish pack printing plant

Contract pharmaceutical services provider Catalent is to install a 10 colour press at its printed components facility in the Irish capital Dublin as part of a company wide effort to expand European operations.

News in brief

Ocimum launches genomic services in Europe

Ocimum Biosolutions BV is launching its genomic services on the Affymetrix platform in Europe from its facility in IJsselstein, The Netherlands.

One-way, temp-controlled shipping will cut export costs, says Pharmafreight

Pharmafreight and Kryotrans have teamed up to offer a one-way, temperature-controlled shipping service that they claim will help pharmaceutical exporters cut costs and boost efficiency.

Perceptive’s Alzheimer’s imaging aims to cut costs

Perceptive Informatics has expanded its offering for trials involving Alzheimer's disease with a new medical imaging method, which it claims produces higher quality, reproducible and regulatory compliant assessments.

San Diego plant will help clients concentrate on R&D, says Althea

Althea Technologies’ biologics and injectables contract development, manufacturing and testing facility in San Diego, US is open for business, bringing to an end the firm’s two year campaign to expand capacity.

News in brief

Bemis confirms talks to buy Alcan Packaging

Bemis has confirmed that “confidential efforts are ongoing” in its attempt to acquire Alcan Packaging, which has been up for sale since mining giant Rio Tinto bought its parent company.

Pharma outsourcing: people on the move

Outsourcing-Pharma provides its latest round up of movements in the pharmaceutical outsourcing sector, including appointments at Cardiocore and HUNT Biosciences.

Biomodels provides screening services to APS

Biomodels is providing preclinical services to Applied Protein Sciences (APS) under the terms of a strategic alliance, which is intended to speed product development and expand pipeline.