The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.
The Government of India will now defer EU trade negotiations as part of its effort to support local CRO GVK Biosciences, which was accused of data manipulation by the EMA (European Medicines Agency).
update - GVK is 'respectful' of EMA recommendation and is working with customers
Indian CRO GVK Biosciences has been named as a preferred provider by a consortium, Product Development Partners (PDP), which is focused on drugs for neglected diseases.
Outsourcing-pharma presents a round up of all the latest deals and developments in the contract research space. This week Synexus closes ClinPharm deal, GVK joins ResearchPoint Global and CliniPace wins gNO contract.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including changes at SRC, Pacific Biometrics, GVK Biosciences and DPT Laboratories.