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.
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.
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.
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.
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.
US CRO PharmaNet will conduct early phase clinical trials of therapeutic cancer vaccines being developed by UK group Scancell under a contract announced yesterday.
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.
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.
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.
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.
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.”
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
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.
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.
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.
Novotech says its new “management hub” in Kuala Lumpur, Malaysia will serve as a base for expansion in the booming Asia-Pacific contract research sector.
inVentiv Clinical Solutions' new Clinical Global Alliance will help meet industry demand for rapid access to “concentrated patient populations” according to CEO Michael Hlinak.
Quintiles is collaborating with Guy’s and St Thomas’ NHS Foundation Trust and King’s College London to establish a 30 bed Phase I site which will help meet demand for early-stage research conducted in patients.
Comparative effectiveness research (CER) represents a “historical market opportunity”, according to a VP at Quintiles who explained that pharmas that do the work will be “properly rewarded for their innovations”.
Health Decisions is “effectively franchising” its clinical trial model to other CROs to create a network of partners that it believes will offer “great flexibility” to clients, according to its COO.
Encorium has abandoned plans to sell its Finnish unit, Encorium OY, citing its new strategic focus and recent contract wins as the basis for the decision.
A spectrum of systems could eventually replace animal testing and provide a more ethical and economical route through preclinical, according to Kate Darley, business development manager at Kirkstall.
Indian CRO Siro Clinpharma has ramped up clinical trial manufacturing capacity at its facility in Mumbai in response to growing demand from pharma and biotech firms.
Lonza says that to the Indian market was a key motivation for its acquisition of Simbiosys Biowares India preclinical cell and molecular biology assets.
NextPharma Technologies has added clinical trial services to its US offering to meet what product development services MD Sean Marett described as growing demand for single source outsourcing solutions.
Quintiles and Cerner are combining their “unique sets of experience and expertise” to improve the efficiency of late phase research, the market for which exceeds $1bn (€677m), according to a SVP at the CRO.
Following a “significant increase in demand” GVK Biosciences has partnered with Quantitative Solutions (QS) to develop and market clinical trial outcome databases, which they believe can improve drug development.
Pharmatek has enhanced its preclinical and early stage clinical GMP supply capabilities by installing Capsugel’s Xcelodose system, becoming the first CDMO on the West Coast, US to have the equipment.
CROs believe that finding the right principal investigators is the hardest part of recruitment, according to a survey that adds that 80 per cent of respondents would prefer to reach enrolment goals 10 per cent quicker than cut costs by 20 per cent.
Hungarian drugmaker Gedeon Richter will use Phase Forward’s Clintrial software package to manage its study programmes under a deal signed late last week.
Diabetes focused drugmaker Diamyd Medical has called in CRO Inclinix Medical to help recruit patients for “rapidly expanding” late-stage trials of its candidate diabetes vaccine Diamyd.
The AAHRPP has issued a major revision of its standards, the first time it has done so, adding sections on transnational research and the separation of business interests from ethics review.
US companies Savvion and Patni Life Sciences hope their new alliance help pharmas biotechs and CROs meet regulatory challenges “across the drug development cycle.”
Axiom Accelerated Patient Recruitment hopes its new range of SMS, text messaging, services can help CROs and pharma sponsors reach more potential study participants.
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.
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.
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.
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.
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.
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.