Collaboration between four companies is supporting clients’ serialisation and ePedigree needs to ensure patient safety, prevent counterfeiting and limit diversion.
Overseas offices will help the FDA schedule inspections more quickly in times of crisis but, as yet, employees based abroad have visited relatively few facilities.
Cost cutting measures helped Parexel to one of its most profitable quarters after taking lower-than-expected revenues on project delays and cancellations.
Inaccurate predictions based on animal models are the biggest cause of clinical failure according to Scottish CRO Biopta, which says use of human tissue samples for preclinical development would cut attrition rates.
Minipigs are a practical and flexible model for safety testing which probably provide better prediction of toxicity in humans than rats and dogs, according to EU funded research.
BioClinica’s Optimiser software has bagged the firm a new five-year deal with a “top-ten” pharma company which intends to use the tool for all its clinical trial operations.
Quintiles and Dako, a Danish-based cancer diagnostics firm, are teaming up to help speed development of personalised medicine by collaborating on the co-development of targeted oncology therapies and diagnostics.
Pfizer has widen its recall of the cholesterol-fighting drug, Lipitor, after two more complaints of a musty odour emanating from the product’s bottles.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at INC Research, Emerald BioStructures and ClinOps.
ACRO wants the US FDA’s overseas offices to play more of a role in monitoring clinical trials, and is calling for an additional $35m (€25.3m) to fund the work.
Aoxing Pharma and Johnson Matthey team up to research, develop, manufacture and market active pharmaceutical ingredients (APIs) for narcotics and neurological drugs in China.
SAGE Labs has unveiled plans to create rodent autism models for preclinical drug discovery and development in collaboration with advocacy group Autism Speaks.
Overseas FDA offices have realised immediate benefits but strategic planning is needed to ensure the ventures, critical aspects of the agency’s ability to ensure drug quality, are long-term successes according to the GAO.
Drug industry demand for chemical intermediates and development projects has rebounded significantly in the last 12 months according to UK group Endeavour Specialty Chemicals.
UK-drugmaker GlaxoSmithKline (GSK) must pay $750m to settle a law suit criticising manufacturing practices at plant in Cidra, Puerto Rico that was shut down in 2009.
Parexel Consulting has released its annual analysis of FDA new drug review trends, which indicates there is a “new normal” emerging in the drug review and approval process.
Lonza is seeing increased capacity utilisation and project pipelines in custom manufacturing but warned more stringent regulatory approval is creating volatility.
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.
PPD is collaborating with the Himalayan Institute and Hospital Trust (HIHT University) to form a large investigator site and expand its network of investigators in Northern India.
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.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Jennerex, a new KV subsidiary and Takeda.
The United States Pharmacopeial Convention (USP) and six government drug control laboratories in the Middle East and Northern Africa (MENA) join to launch a drug quality improvement Network.
Icon reported a two per cent rise in Q3 net revenue, but saw profits dwindle in its central lab business after a growing backlog of work failed to convert to revenue as quickly as expected.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Trident, Agilux and Clinical Trials of America.
Predictive Biomarker Sciences (PBS-Bio) is collaborating with ENDECE, Revalesio and Unibioscreen to help bring new cancer drugs to the marketplace faster.
Horizon Discovery will use its X-MAN human disease cell line models to identify patients likely to benefit from Cylene Pharmaceuticals’ candidate cancer drug, CX-4945.
iGPS is offering what it claims is the world’s first pallet rental service to supply plastic pallets with embedded radio frequency identification (RFID) tags to the pharmaceutical and life sciences industries.
The WHO is today initiating a pilot prequalification programme for selected APIs used in drugs for HIV and related diseases, antimalarials and anti-tuberculosis medications.
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.