in-PharmaTechnologist.com presents its latest round-up of movers and shakers in the world of pharmaceuticals, including news from Cipla, Dr. Reddy’s and Immunogen.
The bioavailability market lacks a leader that can offer comprehensive solutions according to Merck Millipore, which has set its sights on filling the gap through investments and a new lab.
The USP has delayed new elemental impurities standards but is still confident they can be harmonized with ICH Q3D even if May 2014 implementation target is kept.
Euticals Limited has halted API production at its Welsh site after local authorities found it was housing “substantial” quantities of a potentially explosive chemical.
Outsourcing-Pharma.com presents its weekly round-up of the latest movers and shakers in the world of pharmaceutical outsourcing, including news from Onyx, Pacific Biomarker and Rx&D.
The US FDA wants IRBs to remember it is their responsibility to check investigator qualifications, make sure sites are up to code and say if an IND is necessary for the proposed trial.
Outsourcing-pharma.com readers want the acronym CRO to stand for 'contract research organisation' according to the results of a snap poll we ran yesterday.
Outsourcing-pharma.com witnessed a fascinating debate on the definition of ‘CRO’ yesterday with terms like 'collaboration' and 'release' being suggested as potential alternatives.
More analysis suggests that collecting data for non-core endpoints costs individual sponsors millions per clinical trial and the industry billions each year.
UK Government proposals to hand oversight of tissue handling to a non-specialist body would have a negative impact on the preclinical services sector says the Human Tissue Authority.
in-PharmaTechnologist.com presents its weekly round-up of the latest appointments in the pharmaceutical industry, including news from Dendreon, Shire and Targacept.
CMO Synerlab has added lyophilisation and solid dosage form development capabilities to its offering with the acquisition of LyoFal and IDD-Tech Orleans.
A European industry group says EU efforts to ensure the quality of API made by manufactureres outside the region are inadequate and that mandatory inspections of overseas plants are a must.
Domestic regulatory efforts to improve ingredient quality will increase costs but Indian industry will remain competitive, according to the Secretary of Commerce.