Late-stage cancer trials are the biggest challenge for pharmaceutical and biotech firms according to data presented at the Biotechnology Industry Organisation's (BIO) CEO and investor conference in Washington DC, US this week.
Takeda Pharmaceuticals has joined the growing list of pharma companies to forge strategic deals with contract research organisations (CRO) by signing new deals with Covance and Quintiles.
PPD and Charles River Laboratories (CRL) finished 2010 with very different quarters, each posting results that illustrate trends within the CRO sector.
Pfizer’s Centres for Therapeutic Innovation (CTI) has teamed up with seven New York research hospitals to accelerate biomedical research into life-saving medicines, with a focus on biologics.
Oncology registries may be ineffective for recruiting large, representative samples of adolescent cancer survivors to clinical trials, according to research.
ShangPharma has opened a multi-purpose pharmaceutical development cGMP manufacturing facility in Fengxian, China, and started operations on the initial phase of production.
Ecron Acunova has expanded its Mangalore, India, clinical pharmacology unit to house 80 beds as demand rises from US and Canadian clients for pharmacokinetic and pharmacodynamic (PK/PD) studies.
The FDA has issued guidance on electronic data in clinical trials to help eliminate duplication, reduce transcription errors and promote real-time entry.
Merck plans to cash in on the biogenerics industry after forming a partnership with Parexel to develop copies of biologic drugs within its Merck BioVentures division.
PRO Consulting has expanded its range of Patient Reported Outcomes (PRO) offerings to better support drug and medical device developers using PROs in all stages of their clinical development programs.
Serious consideration was given to transferring MHRA clinical trial functions to the HRA after it faced criticism including reports of unprofessional and intimidating GCP inspections.
Creation of a “one-stop shop” for health research approval would free the UK from overly burdensome regulations that are stifling innovation, according to a report.
Biopharm is increasingly using the functional service provider (FSP) model, in areas such as medical affairs and statistical services, while continuing to globalise trials, according to Chiltern.
Novartis will build a new $500m (€379.9m) pharmaceutical manufacturing plant in St Petersburg, Russia after signing a Memorandum of Understanding (MoU) with the city.
INC Research has shifted its headquarters to new and larger offices as part of the firm’s wider plan to ramp up its clinical trials outsourcing operations in Research Triangle, US.
PharmaNet has launched its Initiator data capture and PKS analysis platforms in a bid to speed up data acquisition and processing of Phase I trial reports.
US CRO Dedicated Phase I (DPI) says plan to set up first in human (FIH) unit at Phoenix hospital reflects growing drug industry demand for studies in this setting.
PKPD modelling and simulation is now “ingrained” in drug development and its importance will continue to grow as approaches evolve in “very exciting” coming years, according to an Icon VP.
Understanding cultural and regulatory differences in BRIC countries could help multinational CROs move to the forefront of clinical development and compete with local CROs for drug trial contracts, say researchers.
Pfizer hired investigators to expose corrupt behaviour of the former Nigerian attorney general to ‘pressure’ him to drop legal action against the contentious Trovan drug trial, according to a leaked US embassy cable.
An urgent overhaul of ICH GCP is needed to “reverse the harm” caused by guidance that is bureaucratic, wastes resources and impedes scientific progress, according to a journal.
Kerri Weingard, research director for Accumed, says the growing numbers of patients enrolling in multiple clinical trials are threatening the integrity of the clinical development process.
New research suggests pharmas trialing drugs in BRIC countries are opting to work with smaller, home-grown contract research organisations (CROs) with local knowledge rather than multinational players.
The Christie cancer centre in Manchester, UK, has opened a £35m (€41m) early phase clinical trial unit to help develop new treatments for a range of cancers.
Clinical trials in Latin America recruited 91 per cent more patients per site than studies conducted in the US from 2005 to 2009, according to EU MAA data.
The Association of Clinical Research Organisations (ACRO) has welcomed new trial inspection guidance released by India’s Central Drugs Standard Control Organisation.
Last week everything from co-processed excipients to Viagra-stuffed teddies were discussed at AAPS 2010. Now, with the show having finished, we present our personal take on the event.
An academic clinical research centre that claims CROs markedly increase costs and reduce trial monitoring to box ticking, statements disputed by ACRO, has described its adoption of an in-house system.
Patient recruitment is boosted by health condition awareness strategies and financial incentives, according to research, but various methods of randomisation and consent design have no impact.
PPD signs clinical imaging and formulation development collaborations, reorganises reporting units and cites “improved performance in emerging markets” and spending controls as key to third quarter gains.
Indian CRAs need knowledge of ethics, clinical trial execution and general topics, such as the drug development process, according to a survey into training needs.
Revision to FDA guidance on adverse event reporting is a positive step and forms part of a welcome increased focus on safety, says the CEO of Prism Ideas.