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Canadian CMO Patheon has set up a pharmaceutical development services (PDS) sterile products suite at its manufacturing facility in Ferentino, Italy.
US based chromatography services provider Chiral Technologies says its new separations laboratory in Illkirch, France is open for business.
Clinical trials of cancer vaccines should enrol patients with no evidence of residual disease, according to FDA guidance, but this will increase development times compared to cytotoxic agents.
Axiom Accelerated Patient Recruitment hopes its new range of SMS, text messaging, services can help CROs and pharma sponsors reach more potential study participants.
ClearTrial has expanded its eClinical offering to create “the only system in the industry” that can provide fast and accurate project tracking, management of accrued liabilities and midstream study adjustments.
US companies Savvion and Patni Life Sciences hope their new alliance help pharmas biotechs and CROs meet regulatory challenges “across the drug development cycle.”
Canadian biologics CMO BioVectra has been contracted to make trial supplies of the candidate cancer treatment Prolanta by US biopharmaceutical firm Oncolix.
Fierce competition from India and China means it is unlikely that CROs and CMOs in CEE can generate sustainable growth, according to a report that believes the service model must be a “stepping stone” to creating innovative R&D businesses.
Dutch contract delivery services firm OctoPlus says it will cut 35 jobs as part of ongoing efforts to boost efficiency, improve competitiveness and broaden its client base and revenue streams.
Increased use of adaptive clinical trials and biomarkers will benefit smaller laboratory services companies, according to Pacific Biometrics (PBI) that turned its operating income from loss to profit in fiscal 2009.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Catalent, MedSource and IGI Laboratories and PHT.
Japanese CRO CMIC says rising demand for Medidata Solutions’ Rave EDC system in Asia drove its decision to seek top-level provider status under the US firm’s accreditation scheme.
Contract manufacturer Richter-Helm BioLogics has completed the modernisation of its GMP standard biologics facility in Hannover, Germany.
West has opened its first manufacturing facility in China to meet rising demand but the process has taken since 2006 and been “very tedious”, its president of West Asia Pacific told Outsourcing-Pharma.
US CRO Health Decision says the new “Monitor View” module for its HD360 trial management system makes assessing study site performance an easier and more cost effective process.
The Pan-African Clinical Trials Registry (PACTR) has become the first such database to be endorsed by the WHO, providing the world with access to studies on the continent and improving efficiencies.
Northern Ireland-based contract services firm Almac has been cleared to expand its HQ in Portadown, creating up to 500 new jobs.
Having filed for bankruptcy in December Introgen Therapeutics has sold its assets, including management and technical team, to Vivante, a company that formed last week as a contract manufacturing organisation (CMO).
US CMO Catalent has had its Lovaza softgel manufacturing contract with UK drug major GSK extended.
Quintiles has opened its expanded facility near Edinburgh, Scotland, which has doubled its central lab capacity with the intention of improving the CRO’s service offering in Europe.
ethica Clinical has added biomarker data analysis technology to its roster of services in a C$1.25m (€782,899) deal with fellow Canadian CRO Matrix Pharma.
A US court has ordered the USDA to disclose 1,017 pages of animal testing documents relating to its investigation into HLS, despite testimonies stating that their release could be detrimental to the CRO’s business.
The Chao Center for Industrial Pharmacy and contract manufacturing is to donate $360,000 worth of the antibiotic Seromycin to the Global Health Committee’s fight against multidrug rtesistant tuberculosis (MDR-TB) in Cambodia and Ethiopia.
UK based contract API maker Aesica Pharmaceuticals has been granted a Home Office license to make controlled substances at its facility in Cramlington, Northumberland.
In exchange for services Azopharma is set to take almost 100 per cent equity in ImmuneRegen Biosciences, a biotech with products that are approaching Phase I and being eyed by big pharma, according to its CEO.
US contract research organisation (CRO) GenScript will provide assay development services for Roche’s drug R&D unit in China.
Improved access to data and the ability for users to share comments are among the features added to latest version of Veracity, an electronic data capture (EDC) system from Kika Clinical Solutions.
Datatrak has signed deals for two worldwide studies that it believes demonstrate the ability of its end-to-end eClinical software to serve both academia and industry.
US approval for Sanofi-Aventis’ H1N1 vaccine last week is an “example of extremely rapid action by [the] FDA” that should be used more widely, according to Parexel Consulting’s VP of global strategy services Alberto Grignolo.
GATC Biotech has expanded its human genome sequencing services and, having performed a pilot study, is “amazed” by the potential the techniques have for cancer research and diagnostics.
The FDA is hoping to increase the likelihood of a clinical trial being successful by making best use of science and alternative study designs and has issued end-of-Phase IIa (EOP2A) meeting guidance to explain the process.
Swiss CMO Bachem has been contracted to make supplies of the active pharmaceutical ingredient (API) for development of ImmuneRegen BioSciences’ candidate anti-infective Homspera.
The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing a FDA audit.
US CMO Florida Biologix (FB) says its new contract with America Stem Cell (ASC) shows that demand for trial-phase biologics manufacturing is starting to recover.
LGC Standards has made the “next logical step” in its “concerted effort” to expand internationally by opening an office in St Petersburg, Russia, less than six months after it moved into China.
Portugese CMO Hovione has had its captisol manufacturing contract extended until 2019 in a new agreement with US specialty drugmaker CyDex Pharmaceuticals.
Outsourcing-Pharma views the wages of CEOs at six major CROs using interactive charts to explore their basic salary, incentives and how much they get paid compared to company revenues.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing space, including appointments at IMS Health, CPTC and LAB Research Canada.
New Jersey-based communications group Advogent has had its sales logistics contract renewed by US drugmaker Bristol-Myers Squibb (B-MS).
The Sentinel Initiative will help pharma and CROs pinpoint study objectives, according to a director at PRA who told Outsourcing-Pharma about the company’s postmarketing safety surveillance.
San Diego’s TriLink BioTechnologies has restarted its contract oligonuclotide radio-labelling service after receiving “anxious phone calls” from pharma customers, according to CEO Richard Hogrefe.
Dalton Pharma Services has rolled out a new formulation development service that completes the firm’s contract drug manufacturing offering according to CEO Peter Pekos.
US firm New England Peptide (NEP) says its new PepCRO contract peptide design and characterisation service is a first for the drug industry.
US CRO Symyx has adopted the Safe-BioPharma Associations digital signature standards for its electronic laboratory notebook to” ensure that sensitive intellectual property is securely captured and managed.”
Quintiles has targeted Africa as the next non-traditional area to develop new medicines and the opening of its office in Ghana, which is now fully operational, is a major step in this process, Gillian Corken, head of Quintiles in Africa, told Outsourcing-Pharma.
Funding increases have failed to boost pharma drug development productivity and, with budgets tightening, the industry must revise its operations to improve output, according to a research paper.
UK CMO SCM Pharma says its new commercial supply service, due to be officially launched at next month’s ICSE conference in Madrid, has already won two long-term manufacturing contracts.
Novasep’s API manufacturing facility in Le Mans, France has been certified under the potent compound safety programme run by occupational health and safety specialist SafeBridge Consultants.
Recruiting patients with rare diseases for clinical trials could become easier if the US Congress passes a bill to allow patients on supplemental security income (SSI) benefits to receive compensation.
Lab Research (LRI) aims to boost its Korean presence in a new agency deal with Safe Chemicals that, CEO Luc Mainville says, will meet growing demand for large molecule contract R&D.
A totally outsourced model of discovery is “probably valid”, according to a report that believes pharma must overhaul its operations because its business model is in danger of becoming “irrelevant”.
Market intelligence giant IMS Health has extended its KPO market and sales analytics offering and signed a new collaboration deal with Indian IT contracting group Tata Consultancy Services (TCS).
Phase Forward has adopted technologies from BMC Software to improve its operational efficiency, make “substantial cost savings” and ensure its systems maintain the availability, reliability and compliance demanded by clients.
Perceptive Informatics (PI) has added Optasia’ KneeAnalyzer to its clinical offering, positioning itself for the anticipated surge in number of trials examining musculoskeletal drugs over the next few years
In 25 years most biotechs will be virtual, according to a director of preclinical CRO L2D who formed the company with a “completely novel business model” to target this huge growth opportunity.
Pharma companies can cut the risk of taking a TKI into Phase I by using the HemoRANK in vitro test, according to ReachBio that has developed the assay to evaluate a molecules clinical hematotoxicity.
QPS’ bioanalytical laboratory in Taiwan is the first in the country to be certified as compliant with good laboratory practice (GLP) standards by the Department of health (DoH), according to unit president Vincent Yen.
IT provider DZS Software Solutions’ says its ClinPlus CTMS system has been selected to manage an upcoming trial of PhotoThera’s transcranial laser technology in patients who have suffered acute ischemic stroke.
BioClinica is continuing to acquire companies in the wake of the collapse of its etrials bid, buying software and services provider Tourtellotte Solutions just over two weeks after its last takeover.
Orasi Medical claims CROs and pharmas can cut the cost and length of Alzheimer’s trials, and improve accuracy, by using its brain function measuring service, which is now being promoted in Japan.
Outsourcing to a well known CRO with a good reputation is vital to ensuring that data is well received by regulatory authorities, according to a CEO that just inked a deal for preclinical safety testing.
Quintiles believes there is a “dire need” for trial sites that can raise standards and reduce inefficiencies in the clinical research process and is expanding its Prime Site programme to meet this demand.
Virtify says the new online version of its Virtx CTRR system can help drugmakers comply with the increasingly complex disclosure rules that regulators worldwide apply to clinical trials, in an automated approach that saves time and money.
US contract research organisation (CRO) PPD has set its sights on the Asian biopharma sector with new a lab at the heart of Singapore’s rapidly expanding drug development and trial industry.
Ireland based contract research organization (CRO) Icon has received accreditation for several of its laboratories in Singapore and the UK.
CRO employment levels have soared in recent years, almost doubling at some companies, and this rise, and recent dip, is presented and discussed by Outsourcing-Pharma using an interactive animated chart.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Hovione, Agilux, McKesson and CIT.
Indian CRAMS firm Suven Life Sciences says its discovery partnership with US drugmaker Eli Lilly is beginning to yield results.
Patheon has posted “disappointing” Q3 results, with manufacturing difficulties in Puerto Rico, a slowdown in demand for development services and reduced client demand for some products impacting on revenues.
Colorado trial support services group nSpire Health says its Koko spirometry and PiKoLogic ePro technologies were crucial factors in winning more than $9m (€6.1m) worth of clinical research contracts.
US firms Xybion Medical Systems and Locus Technology say their new animal management and data analysis partnership will help streamline preclinical development and reduce research costs.
A significant number of articles in six of the top 10 medical journals in 2008 were ghostwritten, according to study by editors of JAMA that found responding authors reported a 10.9 per cent rate in the NEJM.
Hyderabad, India-based Makro Care says its GCP “helpdesk” website has already proved to be an invaluable information source for contract research organisations (CRO), investigators and pharma trial sponsors.
Dishman is pushing ahead with its international expansion, increasing efforts to win contracts in the US and Japan and nearing completion of a facility Shanghai, China, which is the first it has built outside of India.
Canadian group Clinical Logistics (CL) and US analysis specialist Gentris have teamed up to develop a dedicated low temperature storage service for clinical cell and DNA samples collected during drug trials.
Angel Biotechnology has inked a deal to manufacture the CTX stem cell line, which can now be frozen and thawed when needed, at its dedicated cell-based therapies plant that is equipped and licensed for the task.
Octoplus has signed a new contract with develop and manufacture Axentis Pharma’s lead product, a candidate cystic fibrosis treatment.
The outsourcing “market is poised to return to healthier growth rates in 2010”, according to the president of MDS Pharma Services who also told Outsourcing-Pharma that CROs will play an increasingly important role in drug development.
US contract research organisation (CRO) Advion BioServices has expanded its biomarker business in an effort to meet growing industry demand for pharmacological analysis.
IT group TechTeam Global and the eClinical Forum are asking Outsourcing-Pharma’s readers to take part in an online survey examining the use of eClinical technologies and electronic data capture (EDC).
Russia-based CRO SynRG has cut the time to prepare a detailed proposal from two weeks to two hours, giving the company a competitive advantage over its rivals, and established a presence in the US to target small to mid-sized companies.
The new partnership with Indian CRO Abridge Clinical Research (ACR) is a unique collaboration offering cost efficient and timely trial solutions according to Global Pharmaceutical Services (GPSI) spokesperson Keith Russell.
Biotechs that partner or outsource in emerging markets are better equipped to innovate and prosper, according to research that warns “if you are not in Shanghai, Mumbai, or Dubai, watch out".
UK API maker and contract manufacturing organization (CMO) Aesica Pharmaceutical has landed a multi-year deal to produce and package drugs on behalf of Amdipharm.
Encorium has outlined plans to specialise in vaccines, which it believes is an area it can be more flexible than big CROs, and inked a swine flu deal as part of $8.7m (€6m) of new contracts.
With Lonza and JLL competing over Patheon Outsourcing-Pharma looks at what the CMO offers to a prospective buyer, analysing its global manufacturing capacity and backlog using interactive maps and graphs.
A top 5 CRO has licensed QTinno from NewCardio, which believes the company will be able to capture additional revenue by providing more accurate and efficient cardiac safety studies.
Covance says its new clinical development offices in Brazil and Mexico will increase access to treatment-naïve patients and, ultimately, save pharmaceutical sponsors money.
Aushon BioSystems has added laboratory and manufacturing capacity to its corporate headquarters to meet rising demand from clinical trials for some of its protein biomarker services.
FDA warning letters to clinical trial investigators have increased by 50 per cent in 2009 as a consequence of improved processes at DSI, a spokesperson told Outsourcing-Pharma.
New multi-million dollar R&D contracts with top three pharma and biotech players go someway to “alleviating” the negative impact of downturn, according to Lab Research CEO Luc Mainville.
Bangladesh represents a “huge opportunity” to pharma, according to the CEO of Amreteck Pharma who believes that CMOs will be attracted by the low costs, which undercut China, and help the industry grow to $10bn (€6.9m) in 10 years.
The Gulf presents a number of opportunities in manufacturing and biotech, according to the president of Majestic MRSS that has recently expanded its operations in the region.
Transcrip Partners’ “augmentation” solution for contract R&D “differs from the normal consultancy alternative by fielding ‘doers’ who can think strategically and ‘thinkers’ who are happy to get their hands dirty” according to senior partner Paul Branthwaite.
US discovery chemistry contractor ChemBridge has made some of its most popular small molecule libraries available on-line through a partnership with preclinical data specialist Collaborative Drug Discovery (CDD).
Where are more clinical trials being conducted, Italy or Illinois, Macau or Mongolia? Outsourcing-Pharma explores these questions and more using interactive maps displaying trials registered with clinicaltrials.gov.
Indian contract research organisation (CRO) Vivo Bio Tech will set up a primate laboratory in Malaysia’s Melaka State in a collaborative effort to boost the regions pre-clinical testing capability.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Cytovance, MPI Research and UBC.
Phlexglobal’s new contract with UCB will improve how the Belgian drug firm manages trials and is indicative of a wider industry move towards eTMF, according to CEO Nicola Murgatroyd.
Bristol-Myers Squibb (B-MS) has outsourced the manufacture of some of its products to Sigma Pharmaceuticals, an Australia-based company that also bought a facility from the big pharma for A$60m ($51.7m).
CMO Encap has expanded its colonic delivery offering and is combining the technology with liquid dosage forms to provide clients with a way to administer a wide range of therapeutics to the region.
Growing demand for independent research staff and shrinking drug R&D spending were the key motivations behind ResearchPoint’s new staffing affiliate ResourcingPoint, according to spokesman Morgan Seaman.
CMO Avid Bioservices’ revenues rose by 74 per cent to $2.1m (€1.5m) in Q2, generating a further $7m from its parent company, and it has plans to boost output and become a leader in mammalian cell culture production.
US CRO and central laboratory services provider Pacific Biometrics (PBI) has entered into a $4m (€2.7m) loan agreement that it says will help further the development of its contract biomarkers business.
Cloud Packaging Solutions has said the acquisition of Toll Packaging will boost its ability to meet the increased demand for shorter packing runs triggered by the current global economic crisis.
CRO Averion is planning to become a private company to reduce expenditure on auditor fees, which could realise savings of $805,000 (€561,000), and allow management to better focus on long-term goals.
Soon CMOs seeking GMP accreditation in India will need to contact the Drug Controller General of India (DCGI), which will be the only body issuing certificates from next month onwards.
AstraZeneca (AZ) has dramatically cut the time taken to initiate a Phase I oncology trial by working with its strategic partner to improve administrative processes and eliminate delays, according to research.
US investment group JLL has described Lonza’s rival offer for Patheon as “a hostile attempt to adversely impact [the Canadian contractor’s] competitive position.”
By acquiring a stake in India-based RSIPL Evotec believes it can offer clients quicker drug development services, an important aspect of coping with attrition, because larger teams of chemists are available in emerging markets.
Following a review of the backlog of postmarketing studies the FDA has initiated changes to improve its processes, including developing Manuals of Policies and Procedures (MAPP) to track the status of trials.
Chiltern has become the sole provider of clinical research staff for monitoring clinical trials for all studies conducted in Western Europe by a top pharma company.
US contract services firm PharmaForm has cut its workforce to 65 employees in a restructuring plan that parent company Akela Pharma said optimises its client support infrastructure.
An “enormous leap in productivity” can be achieved by applying the principles of adaptive trials to broader operations, such as recruitment, according to a CEO that thinks CROs have to adopt the method.
Biotechnology firm Cel-Sci claims the “True Cold” low-temperature fill and finish service at its new manufacturing facility near Baltimore, Maryland is a first for the global contracting sector.
Clinical trials registered in India have soared in the past 12 months, as the nation has shifted its policy on recording full study details from voluntary to advisory and in June to mandatory.
Facing “unparalleled” challenges MDS is seeking a buyer for its Pharma Services division, and claims to have begun discussions with two interested parties, to allow it to focus on its Nordion business.
Stemedica Cell Technologies’ new license to make stem cells for trials positions the firm as a “valuable resource for front line researchers,” according to VP of business development Dave McGuigan.
Raland Technologies is targeting growth in pharma and biotech sectors once its proposed merger with Premier Technical Services is complete.
The Californian budget deficit presents a “real risk to future biotech investments”, according to the CEO of BayBio who explained to how the industry now has a difficult relationship with the state.
Synexus is meeting the rising demand for its services, which it says can dramatically increase recruitment rates, by acquiring clinical trial sites in Poland and is hoping to expand in India soon.
With the next round of financial results coming up Outsourcing-Pharma takes a look at the growth of seven CROs over the past three years and how the downturn has impacted on them.
US firm PerkinElmer has opened a second plant to meet growing demand for radiolablled compounds for ADME and, it hopes, ultimately help drugmakers make go/no go development decisions earlier.
US CRO Clinilabs hopes its new link up with Chinese counterpart H&J CRO International will allow it to “manage early phase and specialty studies in the US, while offering our clients the cost efficiencies found in the Asian labour market.”
Summit has sold Dextra, its analytical and manufacturing services division, to NZP but believes operating the contract business has been beneficial to its industry standing and R&D capabilities.
Sweden’s XSpray Microparticles says its new particle plant proves its RightSize tech can be scaled-up for industrial applications and will be a boost for its contract services offering.
Cobra Biomanufacturing’s new Adenovirus manufacturing and process services contract is further evidence of the health of EU biologicals market, according to business development manager Philip Ridley-Smith.
Drug development partnering site goBalto’s addition of Latin American clinical sites to its database in a deal with Chilean CRO Clinical Trials Support (CTS) is timely given the pharma and biotech industry’s focus on emerging markets.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Laxai, LabConnect, ERT and Avid Bioservices.
CMO SynCo Bio Partners has entered the Japanese biologics production market, which it views as a growth opportunity, by signing its first contract with an emerging company based in the country.
Pharmaceutical and cosmetics contract manufacturing organisations (CMOs) in India can now claim tax credit on their advertising spend following a recent appeal court victory for US beverage giant Coca-Cola.
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