Breaking News on Contract Research, Manufacturing & Clinical Trials

QSI installs ERP system

Infosys Technologies has helped CRO Quantum Solutions India (QSI) implement Microsoft Dynamics NAV 2009 which will allow data management, process harmonisation and reduce delays.

IQWiG calls for EU trial disclosure laws, says Pfizer delayed report

IQWiG says Pfizer’s refusal to make some data available “hindered” its report on antidepressants and called for EU mandated trial registration and publication rules.

World Courier network meets GxP requirements

World Courier has GxP compliant status for its whole distribution network, covering more than 140 offices in 50 countries, which it believes no other business in the sector has achieved on such a large scale.

News in brief

Dishman Netherlands opens HPAPI lab

Dishman’s Dutch subsidiary has formally opened a new potent API development, testing and scale-up manufacturing laboratory.

Few pharma plants will be sold to CMOs; report

The recent wave of M&A will lead to manufacturing over-capacity at pharma companies but only a small number of these sites will be sold to CMOs, in part because of the facilities’ suboptimal locations, according to a report.

Synexus hails recruitment for vaccine trial

Synexus has recruited more than 2,000 children in three months for a Phase III rotavirus vaccine study, which it believes validates its methods and demonstrates they are particularly effective in late stage vaccine trials.

News in brief

Jubilant partners with US researchers on drug development

Indian CRAMS firm Jubilant Organosys has teamed up with the University of Alabama (UAB) and the Southern Research Institute (SRI) to develop affordable treatments for cancer, infection and metabolic disorders.

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PX'Therapeutics expands manufacturing site

PX'Therapeutics SA, formerly called Protein'eXpert, has set up an additional biomanufacturing unit dedicated to producing therapeutic proteins and monoclonal antibodies in mammalian cells.

Lonza to make trial stocks of Micromet cancer MAb

Lonza will produce trial supplies of Micromet’s candidate blood cancer treatment blinatumomab under a contract announced today.

CMO market worth $33.7bn by 2014

The market for contract manufacturing organisations (CMO) will be worth $33.7bn (€22.4bn) by 2014, according to a report which says developing biologics capabilities is a key imperative for growth.

NexMed to buy CRO Bio-Quant to boost Nasdaq compliance bid

US pharmaceutical firm NexMed hopes the planned acquisition of preclinical CRO Bio-Quant will help maintain its Nasdaq listing.

Icon eyeing China

Icon is looking to expand its bioanalytical capacity in Asia, notably in China, and bolster its genomics, proteomics and cell-based assay capabilities, according to a VP who discussed diversification of the business.

Sistemic setting up in US

Sistemic is targeting the US by setting up an office in Boston, Mass, from which it will promote its services that use miRNA to identify and understand a compound’s activity in a simpler way than genomics or proteomics.

News in brief

CDAS & Prestwick partner

CDAS has entered into a strategic partnership with Prestwick Chemical to provide customised outsourced medicinal chemistry and in vitro and in vivo preclinical biology programmes.

14 C "synth to clinic" simplifies development process, says Quotient CEO

UK contract services firm Quotient Bioresearch says its "Synthesis-to-clinic" service for 14 C labelled compounds can simplify early drug development.

MDS restructuring had little impact on early stage; VP

The splitting up of MDS Pharma Services had little impact on the remaining business as there was limited integration anyway, according to a VP who detailed how the divestitures have allowed resources to be focused on core strengths.

People on the move: pharma outsourcing jobs

Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Patheon, Pharmarama and Omnia Biologics.

News in brief

Pharma must change how it sells products, Deloitte consulting

The drug industry must “fundamentally change” how it sells products and make greater use of advanced analytics to measure performance, according to a report by Deloitte Consulting.

PPD targets NJ, PA

PPD’s acquisition of Merck’s vaccine testing laboratory will give it a geographic location from which it can compete for business with its “number one competitor”, which is well established in the north east of the US.

Further boost for Covance’s biomarker offering in RBM deal

Covance will outsource biomarker activities to US laboratory group Rules-Based Medicine (RBM) in an exclusive deal announced yesterday.

Further boost for Covance’s biomarker offering in RBM deal

Covance will outsource biomarker activities to US laboratory group Rules-Based Medicine (RBM) in an exclusive deal announced yesterday.

News in brief

Almac completes work on Durham expansion

Almac hopes new capacity at its US facility in Durham, North Carolina will promote greater synergy between its clinical services and diagnostics units for the benefit of its customers.

Work needed to close gender knowledge gap

Regulators, industry and academia must do more to close the knowledge gap created by a historic shortage of women in clinical trials, according to speakers at AAPS 2009.

eClinical definition is changing; SVP

Phase Forward is moving towards offering integrated systems to meet pharma’s need to maximise cost effectiveness and deal with upcoming EDC market saturation, according to a SVP at the company.

News in brief

PharmaNet lands Scancell trial contract

US CRO PharmaNet will conduct early phase clinical trials of therapeutic cancer vaccines being developed by UK group Scancell under a contract announced yesterday.

PPD awarded $330m development contract with Janssen

PPD will work with J&J’s Belgian subsidiary, Janssen Pharmaceutica, on drugs for bowel, skin and lung diseases in a $330m in a deal announced yesterday.

Icon plans for 35,000 sq ft site at hospital

Icon is currently planning to occupy over a third of the 100,000 sq ft redeveloped hospital in Manchester, UK, which is due to open in 2012 and will become a flagship site for the CRO.

News in brief

Lonza to manufacture GSK’s Arzerra

Lonza is manufacturing GlaxoSmithKline’s (GSK) and Genmab’s antibody Arzerra (ofatumumab), which was recently approved by the FDA, under a long-term supply deal.

WuXi grows in Q3

WuXi PharmaTech’s operating income increased by 35 per cent in the third quarter, underpinned by strong growth in China-based laboratory services, but its manufacturing operations continue to struggle.

Catalent: Irish pack plant gets ISO 15378; Swindon job cuts

US contract manufacturing organisation (CMO) Catalent’s packaging facility in Dublin, Ireland has achieved ISO 15378:2006 under the ISO’s quality scheme.

People on the move: pharma outsourcing jobs

Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including multiple appointments at Almac and a new chairman at TranScrip Partners.

Pharma turning to SAAS

Pharma’s increasing collaboration and budget cuts have made hosted software more attractive to companies, according to Symyx which has made its lab notebook available on this platform.

News in brief

CSM partners to enter EU

US-based Clinical Supplies Management (CSM) has partnered with CRID Pharma, a French company with CMC expertise, to share resources, broaden their global distribution network and cut costs and times.

Delivery Science teams up with URI for testing services

US contract polymer maker Delivery Science has ramped up its formulation and analytical testing offering in a partnership with the University of Rhode Island’s (URI) College of Pharmacy.

Parexel adds cardiac tech

Parexel has entered into an alliance with Mortara Instrument to bolster its early phase cardiac safety capabilities and improve the assesment of new compounds.

Galenix and DSM sign manufacturing and marketing accord

French drug delivery specialist Galenix has named DSM’s pharmaceutical products unit as its manufacturing and co-marketing partner as it continues to efforts build its global presence.

News in brief

Stanford joins NIH ResearchMatch recruitment organisation

Stanford University Medical School has become the latest institution to sign up to the US NIH’s ResearchMatch trial recruitment network.

AAPS - trends in turbulent times

AAPS 2009 has drawn to a close but over the three days numerous trends and debates emerged, including the strategies CROs are using in the downturn, and we take a look at these in our conference round up.

Biovail highlights contract biostats offering at AAPS

Canada’s Biovail Contract Research says its stand-alone biostatistics unit will help sponsors “anticipate roadblocks ahead of time and create a sound statistical analysis plan for optimal results.”

News in brief

Seventh Wave and TNO announce GI modelling pact at AAPS

Seventh Wave Laboratories will apply gastrointestinal modelling to the analysis of early stage drug candidates being developed by its customers.

Genmab selling plant and turning to CMOs

Genmab has put its Brooklyn Park, Minnesota, US facility up for sale, which will reduce its headcount by 300, and plans to use CMOs to cover for the loss of capacity.

AAPS - round up of day one

Following the first full day of AAPS 2009 in Los Angeles, California, US we take a look at the major developments and talking points.

Parexel forms Expert Office

Parexel has established The Expert Office to provide a single point of contact for clients which want the CRO’s team to assist them with optimising all aspects of the clinical trial process

People on the move: jobs in pharma outsourcing

Outsourcing-Pharma presents its latest round up of movements in the pharmaceutical outsourcing sector, including appointments at PharmaNet, Kendle and INC Research.

News in brief

Catalent teams up with Endotis on oral oligo delivery

Catalant will work with Endotis Pharma on the development of orally-deliverable formulations of oligosaccharides under a deal signed last week.

PharmaForm rolls out contract spray-drying service

US CMO PharmaForm has added spray-drying to its contract offering to capture a share of the ever-present market for drug bioavailability enhancement.

News in brief

Shire extends Medidata trial management contract

Medidata Solutions has won a multi-year extension to its benchmarking and analysis contract with drugmaker Shire.

Lonza buys into immunogenicity

Lonza has bolstered its protein design capabilities by acquiring Algonomics, a CRO with technologies which predict immunogenicity to improve development of protein therapeutics and vaccines.

Catalent unveils ulta-sensitive melamine test for drugs

US contract services firm Catalent has launched a new test service capable of detecting trace amounts of the toxic chemical melamine in pharmaceuticals.

CTI buys German research staffing firm CRS

Ohio, US-based CTI Clinical Trial and Consulting Services (CTI) has bought German trial staffing specialist CRS Clinical Research Services (CRS) to build its presence in Europe’s contract research sector.

West laying off 100 staff

West Pharmaceutical Services is laying off 100 staff as part of restructuring efforts after its third quarter results fell short of expectations, despite operating profit increasing by 45 per cent.

Charles River cuts guidance as sales fall

The availability of preclinical capacity and uncertainty created by mergers and healthcare reform have led to pharma exerting pricing pressure on Charles River, decreasing its sales by 13.1 per cent, and it expects the situation to worsen in Q4.

AFMPS OK for NextPharma's sterile product development centre

NextPharma’s sterile product development centre (SPDC) is set to become operational after clearance by Belgian regulators.

PharmaNet and Phase Forward sign EDC deal

PharmaNet will offer Phase Forward’s InForm EDC and trial management platform to customers under a new deal announced today.

News in brief

Cambrex up in Q3

Cambrex’s operating profit grew by 24 per cent year-on-year supported by higher volumes of an API using its polymeric drug delivery technology and higher controlled substances and custom development revenues.

News in brief

Toxikon wins preclinical Kevetrin contract

US CRO Toxikon will conduct early-phase studies of candidate cancer treatment Kevetrin in a deal with developer Cellceutix.

Quintiles inks pharma deals

Quintiles is continuing to build alliances with large pharmas, inking deals to perform “the majority” of AstraZeneca’s (AZ) clinical pharmacology work and develop six oncology products in Eisai’s pipeline.

Penn completes phase one of Tredegar plant expansion

Welsh contract services firm Penn Pharmaceuticals has reorganised its transport and delivery infrastructure in the first phase of a £12m (€13.3m) expansion at its facility in Tredegar.

People on the move: pharma outsourcing jobs

Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Synteract, Quintiles, Quanticate and ClinOps.

News in brief

IRB Schulman sets up Canadian operation

US IRB Schulman Associates has opened an office in Canada in response to growing customer demand for clinical trial review services in the country.

Phase Forward plans bright 2010

In Q3 Phase Forward’s revenues from CROs grew by 44 per cent year-on-year and it predicts a bright 2010, as a backlog of delayed trials are started and big pharma attempts to cut IT costs.

Lonza cuts 2009 guidance 14% and plans workforce cuts

Lonza cuts 2009 earning guidance and may reduce its workforce under “Project Bond” cost cutting plan after a Q3 characterized by an “accumulation of unexpected events”

MDS’ Central Labs becomes Clearstone Central Laboratories

MDS’ Central Labs has been rebranded as Clearstone Central Laboratories following its acquisition by Czura Thornton, which is looking to expand the business and that of Chiltern, a CRO also owned by the investment company, into new geographies, according to its co-founder.