Breaking News on Contract Research, Manufacturing & Clinical Trials

All news articles > March 2009

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31-Mar-2009

Preclinical CRO Porsolt expands in France, US

Porsolt, a French contract research organisation (CRO) specialising in preclinical pharmacology services, has said it plans to open a new facility in Europe as well as boost its presence on the other side of the Atlantic.

Nutra Pharma branches out into contract services

ReceptoPharm, a subsidiary of US biotechnology company Nutra Pharma, is to start offering contract research and manufacturing services for life science companies.

Lilly seals cardiovascular R&D deal with Zydus

Eli Lilly’s pursuit of outsourcing deals continues unabated with the pharma major entering into a cardiovascular R&D collaboration with Zydus Cadila that has been described as a “new paradigm for global alliances”.

SDTech and Malvern team up on process optimisation

Custom micronisation and milling firm SDTech has bolted on particle size analysis to its suite of drug industry offerings through a new collaboration with UK analysis specialist Malvern Instruments.

News in brief

Patheon bolsters regulatory offering through Swiftwater deal

Patheon has teamed up with drug development consultant Swiftwater to offer customers advice and guidance on regulatory and compliance issues.

30-Mar-2009

Patheon seeks legal advice on JLL hostile bid

The committee set up by Patheon to review the unsolicited bid by private equity firm JLL to take control of the firm has asked for advice on the legality of the move.

Pharma outsourcing: people on the move

Outsourcing-Pharma.com presents its periodic round-up of executive appointments in the contract services sector and pharmaceutical industry.

News in brief

Almac completes 1st stage construction of US facility

Almac Clinical Service finished the first stage of construction at its $78m (€59m) facility in Pennsylvania, US last week, setting the final piece of steel framing in place in a ceremony attended by division president Robert Dunlop.

SAFC launches service to secure supply chain

SAFC has launched its Vendor Audit Services that are designed to increase clients’ confidence in the supply chain by providing traceability and quality confirmation of raw materials.

Drugmakers still confused by CFR-21 parts 210 and 211, says West

Since coming into effect late last year, US Code of Federal Regulations-21 parts 210 and 211 testing rules have been the subject of much confusion in the pharmaceutical industry, according to West Pharmaceutical Services.

26-Mar-2009

Flexibility is key for processing sector says Millipore

Flexibility is going to be a key driver for the pharmaceutical market in the next few years, according to Millipore's VP of downstream processing Paul Chapman.

Grassley and Torti face-off over whistleblowers

Senator Grassley has raised concerns that an email by acting Commissioner Torti to FDA employees could be viewed as an attempt to suppress whistleblowers following recent releases of internal agency documents.

Borealis film stays clear even post-sterilisation

Borealis is launching a new cast film that it claims offers best-in-class transparency, high purity and can be tailored to a client’s needs, making it ideal for packaging manufacturers needing clear coverings.

J-Pac hopes to become Doyen of contract thin-film cutting and sealing

Contract manufacturing and packaging firm J-PAC’s addition of thin film converting and sealing capacity to its roster of services completes its offering according to CEO Richard Eagling.

25-Mar-2009

Pharma mega mergers a boon for Patheon's restructuring service, says CEO

The global economic downturn, impending blockbuster patent expiries and the wave of consolidation sweeping the pharmaceutical industry will drive demand for Patheon’s restructuring service according to CEO Wesley Wheeler.

News in brief

Cosmo predicts recovery of CMO business

Italy’s Cosmo Pharmaceuticals says that royalty and milestone income from its contract drug manufacturing business will return to growth this year after dropping for the quarter ended December 31.

AstraZeneca and BioDuro expand discovery contract

The Chinese unit of US contract drug discovery firm BioDuro says that AstraZeneca has expand its relationship with the firm to include the optimization of discovery research operations focused on drugs for respiratory and inflammatory disease.

Systems Biology Worldwide buys 4Pharma

Contract drug development group Systems Biology Worldwide (SBW) says the acquisition of Finnish data management specialist 4Pharma will facilitate its entry into the clinical trials sector.

24-Mar-2009

Snapshot of technologies at Interphex 2009

St Patrick’s Day celebrations weren’t the only thing bringing people together in New York last week as the pharmaceutical manufacturing and outsourcing industries gathered at the Jacob K Javits convention centre for Interphex 2009.

Vetter launches VPI subsidiary

Vetter Pharma-Fertigung (VPF), a specialist provider of pre-filled injection systems, has formed a new subsidiary, Vetter Pharma International (VPI) to take charge of sales, marketing and customer services.

HP claims it can cut costs for 80% flexo printing

Hewlett-Packard has made its high-volume digital press commercially available, which it claims can cut waste, warehousing and environmental impact compared to analogue printing.

23-Mar-2009

Packaging feeling effects of downturn, says Alcan pharmaceutical packaging president

Michael Schmitt, president of Alcan Global Pharmaceutical Packaging, believes a recovery in the global economy, the increasing demand for quality and the emergence of markets like India and Brazil will be key drivers for the packaging sector over the next few years.

Catalent closing site in re-jigging of US ops

Catalent is adjusting its packaging operations by closing one facility and simultaneously expanding another, which it believes will improve the service offered to its folding carton customers.

Honeywell wins US Shire contract

Industrial manufacturing specialist Honeywell has been contracted to manage and control production processes at the newly constructed US operations of UK biotechnology company Shire.

SGS opens new micro test lab in China

SGS Life Science Services opened a new microbiology testing laboratory in Shanghai, China to offer cGMP compliant API testing services for method development and validation.

19-Mar-2009

News in brief

PLF International appoints new sales director

PLF International has appointed a new sales director to drive organic growth and take the packaging machinery firm into new market sectors.

Real-time analysis of tablet surfaces

UK company Paraytec has introduced a new instrument designed to allow formulation scientists to visualise – in real time – what is happening at a tablet surface when it dissolves.

Braille standard drawn up for US pharma packaging

A US trade organisation has drawn up its own set of standards for Braille on pharmaceutical packaging in the absence of any legislative decision by the US.

18-Mar-2009

CIT adds MAb testing as demand rises

CIT is launching a tissue cross-reactivity service, which will allow biotechs to screen monoclonal antibody-based therapies for tissue binding, in response to rising market demand.

MDS earnings blitzed by slumping revenues

The tough operating climate facing contract research organisations (CROs) seems to have hit Canada’s MDS particularly hard, with a 13 per cent drop in fiscal first quarter revenues to $257m.

Covance boosts Phase I capacity with SPC buy

Covance has expanded its clinical pharmacology capabilities via the purchase of Swiss Pharma Contract, a 50-bed clinical research company based in Basel.

EMEA reflects on non-EU clinical data

The European Medicines Agency (EMEA) has called for “in-depth, prospective analysis of potential ethnic factors” when considering whether clinical trials conducted outside the EU will be acceptable in marketing authorisation applications.

17-Mar-2009

Pharmacopoeias diverging on heavy metals testing?

The three main international pharmacopoeias in the US, Europe and Japan are experiencing a difference of opinion on the tricky topic of testing pharmaceutical ingredients for heavy metals.

FDA raises standards for import testing labs

The safety of drugs imported into the US remains high on the FDA’s agenda, with the agency publishing new draft guidance that raises standards for labs inspecting products made overseas.

Meet our team at Interphex 2009

Planning to visit Interphex 2009 at the Jacob Javits Convention Center in New York City? Then why not visit our Booth 731 in Exhibition Hall D?

16-Mar-2009

IPECs may emerge in Latin America, India

The International Pharmaceutical Excipients Council (IPEC) – currently represented by divisions in Europe, the Americas, Japan and China – could see sister organisations open up in Latin America and India in the coming months.

Falling biopharma sales hurt Pall’s Q2; but Asia shows promise

Pall CEO Eric Krasnoff says delayed drug industry capital expenditure and moves to conserve inventory in the current global gloom caused life science sales to fall 8 per cent for the second quarter.

Cel-Sci’s contract cold filling process could improve biologics

US Biotechnology firm Cel-Sci has unveiled a new manufacturing process, cold 4°C Aseptic Filling, that it claims can improve the shelf-life and potency of biologic drugs produced using stem cells.

Second lyophilizer goes online at Formatech in Andover

US CMO Formatech has brought a new Virtis Benchmark 3000 luophilizer into service at its manufacturing facility in Andover, Massachusetts, boosting capacity by 13,000 vials per production run.

12-Mar-2009

JLL starts Patheon acquisition bid

Private equity firm JLL Patheon Holdings went ahead yesterday with its unsolicited $2-per-share bid for Patheon that would take the company into private ownership.

ACM binds Pivotal into the central laboratory fold

US contract research organisation ACM Global Central Laboratory has bought its longstanding business partner Pivotal Laboratories of the UK in a bid to boost its international reach.

Driam launches cycled continuous tablet coating system

German coating technology specialist Driam hopes its new Driaconti-T continuous tablet coating platform will win over manufacturers wishing to improve process efficiency in times of economic gloom.

PDII losses mount in “very disappointing” ‘08

The slashing of pharma’s in-house teams did not help contract sales provider PDII in 2008, with the company recording an operating loss of $36.4m (€28.5m), compared with a $14.3m deficit the previous year.

11-Mar-2009

UCB taps Proteros for crystallography services

Belgian biopharmaceutical company UCB has contracted Proteros Biostructures of Germany to provide support in the structure-based discovery of small-molecule drugs.

Richmond launches new data management offering

UK CRO Richmond Pharmacology has unveiled a new data management offering for the drug industry that it claims will help trial sponsors cut costs, save time and help guarantee data integrity.

Biofocus swings to profit in 2008

BioFocus DPI, the service division of Belgian drug discovery firm Galapagos, made a profit of €3.4m on revenues a little over €56m in 2008, reversing a loss of about the same magnitude in 2007.

10-Mar-2009

Pharma outsourcing: people on the move

Outsourcing-Pharma.com presents its periodic round-up of executive appointments in the contract services sector and pharmaceutical industry.

etrials CEO says ‘08 was ‘challenging’

eClinical company etrials saw losses increase in the fourth quarter of 2008, but pointed to a healthy increase in orders as evidence of the underlying strength of the business.

Cost cutting shows Q1 benefits for Patheon; but manufacturing earnings fall

Patheon chief Wes Wheeler says the drop in Q1 losses the firm recently reported is due to the “restructuring activities and rigorous cost containment efforts” it enacted towards the end of last year.

09-Mar-2009

Tigermed aims big with MacroStat alliance

Tigermed is continuing with its plan of partnering to become the top Chinese CRO through an alliance with MacroStat to improve its range of statistical services, further broadening its business.

PPD doesn’t expect alogliptin milestone this year

PPD says it is unlikely to receive a $25m (€20m) milestone for US approval of Takeda’s diabetes drug alogliptin this year after the FDA said that cardio vascular (CV) safety data filed as part of the NDA are insufficient.

Alleged mistreatment of apes provokes anger

An undercover investigation at a primate centre that conducts preclinical research has raised allegations of routine and unlawful mistreatment of the apes and wastage of taxpayers’ money.

News in brief

Burgopak uses consultancy to protect IP

Burgopak has employed the services of PA Consulting Group to ensure its intellectual property (IP) is well protected prior to partnering with a high volume manufacturing company.

05-Mar-2009

Penn Pharma expands in Wales

At a time when many companies are downsizing, UK-based contract manufacturer Penn Pharmaceuticals has just announced a £12m (€13.5m) redevelopment project that could see the creation of 133 new jobs.

Struggling PharmaNet launches new flexible staffing service

US CRO PharmaNet hopes its new trial staffing service will provide an additional revenue stream and help stave-off plummeting 2008 incomes and compensate for a series of painful contract cancellations.

C&QP partners to launch Evolution of GMP services

Evolution is collaborating with C&QP to offer a more comprehensive range of GMP services to clients, covering plant and equipment qualification, calibration and maintenance.

"Fundamentals for contract research remain strong," says F&S' Barath Shankar

With M&A activity dominating Big Pharma's agenda at the moment, the contract research market is having to evolve and adapt to the turbulent environmnet. Outsourcing-pharma asked Frost & Sullivan analyst Barath Shankar to offer his opinion on the state of the sector and to predict how it will develop.

News in brief

SCM completes lisinpril supply for major RA trial

UK CMO SCM Pharma has completed a supply contract to make lisinopril tablets for a University of Cambridge trial investigating the drug in Rheumatoid arthritis.

04-Mar-2009

PFC to run Swiss Oxyctye Ph II trials

Swiss CRO PFC Pharma Focus has won the contract to conduct Phase II trials of for Oxygen Therapeutics’ candidate perfluorocarbon (PFC) therapeutic oxygen carrier Oxycyte for the treatment of traumatic brain injury (TBI).

Imaging service aims to save trial sponsors time and money

Money can be saved throughout early-stage and Phase II trials by using the Collect, Ready, Hold service in preemption of a central review of imaging data, according to WorldCare Clinical.

Slowdown affecting rebranded eResearch Technology

Cardiology and eClinical specialist eResearch Technology missed analysts estimates of sales and earnings in the fourth quarter of 2008, but still posted a near-14 per cent increase in operating profit.

03-Mar-2009

CML and Novacta team up to target process outsourcing sector

UK firms Cambridge Major Laboratories (CML) and Novacta Biosystems are to collaborate and develop a range of process development, custom synthesis and biocatalysis offerings for the pharmaceutical industry.

InVentiv posts loss despite rising revenues

Sales and marketing service specialist InVentiv Health slid to a loss in the fourth quarter of 2008, despite posting a 16 per cent hike in net revenues to $248m.

Pain continues for PharmaNet in Q4

Nose-diving net income in Q4 brought PharmaNet’s torrid year to an end, with the CRO hoping what may be its last financial release as a public company marks the start of its revival.

News in brief

Reprint service aims to save pharma’s cash

Reprints Desk has launched a new group purchasing software service, which will see the company assist pharmaceutical firms in consolidating their article reprint buying.

02-Mar-2009

Partnership aims for complete toxicology model

Genstruct and Gene Logic are partnering to improve their service offerings, with the collaboration hoping to produce network models that fully capture the toxicity potential of any compound.

ChanTest buys GPCR specialist

Contract research company ChanTest has acquired fellow US firm Applied Clinical Sciences, a specialist in the development of drugs that affect G-protein coupled receptors (GPCR), one of the most fertile areas of drug discovery.

ISO 15378:2006 award is competitive advantage for French plants, says Alcan

Three plants owned by contract packaging maker Alcan have been cleared to produce containers for pharmaceutical products under the International Organization for Standardization’s ISO 15378:2006 guidelines.

News in brief

Improvements to infusion studies on up to 300 lab animals

Instech Solomon and Xybion Medical Systems Controlling are collaborating to ease the process of controlling flow rate and administration volumes to large numbers of lab animals.

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